General Information

Cellular Classification

Stage Information

Treatment Option Overview

Stage 0 Esophageal Cancer

Stage I Esophageal Cancer

Stage II Esophageal Cancer

Stage III Esophageal Cancer

Stage IV Esophageal Cancer

Recurrent Esophageal Cancer

GENERAL INFORMATION

The incidence of esophageal cancer has risen in recent decades, coinciding with a shift in histologic type and primary tumor location.[1,2] Adenocarcinoma of the esophagus is now more prevalent than squamous cell carcinoma in the United States and western Europe, with most tumors located in the distal esophagus. The cause for the rising incidence and demographic alterations is unknown.

Gastrointestinal stromal tumors can occur in the esophagus and are usually benign. (Refer to the PDQ summary on Adult Soft Tissue Sarcoma Treatment for more information.)

While risk factors for squamous cell carcinoma of the esophagus have been identified (tobacco, alcohol, diet, etc.), the risk factors associated with esophageal adenocarcinoma are less clear.[2] The presence of Barrett's esophagus is associated with an increased risk of developing adenocarcinoma of the esophagus, and chronic reflux is considered the predominate cause of Barrett's metaplasia. The results of a population-based, case-controlled study from Sweden strongly suggest that symptomatic gastroesophageal reflux is a risk factor for esophageal adenocarcinoma. The frequency, severity, and duration of reflux symptoms were positively correlated with increased risk of esophageal adenocarcinoma.[3]

Esophageal cancer is a treatable disease that is rarely curable. The overall 5-year survival rate in patients amenable to surgery ranges from 5% to 20%. The occasional patient with very early disease has a better chance of survival. Patients with severe dysplasia in distal esophageal Barrett's mucosa often have in situ or even invasive cancer within the dysplastic area. Following resection, these patients usually have an excellent prognosis.

Primary treatment modalities include surgery alone or chemotherapy with radiation therapy. Combined modality therapy (chemotherapy plus surgery, or chemotherapy and radiation therapy plus surgery) is under clinical evaluation. Effective palliation may be obtained in individual cases with various combinations of surgery, chemotherapy, radiation therapy, stents,[4] photodynamic therapy,[5-7] and endoscopic therapy with Nd:YAG laser.[8]

One of the major difficulties in allocating and comparing treatment modalities for patients with esophageal cancer is the lack of precise pre-operative staging. Standard noninvasive staging modalities include computed tomography (CT) of the chest and abdomen, and endoscopic ultrasound (EUS). The overall tumor depth staging accuracy of EUS is 85% to 90%, as compared to 50% to 80% for CT; the accuracy of regional nodal staging is 70% to 80% for EUS and 50% to 70% for CT.[9,10] EUS-guided fine-needle aspiration (FNA) for lymph node staging is under prospective evaluation; one retrospective series reported a 93% sensitivity and 100% specificity of regional nodal staging with EUS- FNA.[11] Thoracoscopy and laparoscopy have been used in esophageal cancer staging at some surgical centers.[12-14] Noninvasive positron emission tomography using the radiolabeled glucose analog 18-F-fluoro-deoxy-D-glucose for pre-operative staging of esophageal cancer is under clinical evaluation and may be useful in detecting stage IV disease.[15]

References:

1. Devesa SS, Blot WJ, Fraumeni JK Jr: Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer 83(10): 2049-2053, 1998.
2. Blot WJ, McLaughlin JK: The changing epidemiology of esophageal cancer. Seminars in Oncology 26(5 suppl 15): 2-8, 1999.
3. Lagergren J, Bergstrom R, Lindgren A, et al.: Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. New England Journal of Medicine 340(11): 825-831, 1999.
4. Tietjen TG, Pasricha PJ, Kalloo AN: Management of malignant esophageal stricture with esophageal dilation and esophageal stents. Gastrointestinal Endoscopy Clinics of North America 4(4): 851-862, 1994.
5. Lightdale CJ, Heier SK, Marcon NE, et al.: Photodynamic therapy with porfimer sodium versus thermal ablation therapy with Nd:YAG laser for palliation of esophageal cancer: a multicenter randomized trial. Gastrointestinal Endoscopy 42(6): 507-512, 1995.
6. Kubba AK: Role of photodynamic therapy in the management of gastrointestinal cancer. Digestion 60(1): 1-10, 1999.
7. Heier SK, Heier LM: Tissue sensitizers. Gastrointestinal Endoscopy Clinics of North America 4(2): 327-252, 1994.
8. Bourke MJ, Hope RL, Chu G, et al.: Laser palliation of inoperable malignant dysphagia: initial and at death. Gastrointestinal Endoscopy 43(1): 29-32, 1996.
9. Ziegler K, Sanft C, Zeitz M, et al.: Evaluation of endosonography in TN staging of oesophageal cancer. Gut 32(1): 16-20, 1991.
10. Tio TL, Coene PP, den Hartog Jager FC, et al.: Preoperative TNM classification of esophageal carcinoma by endosonography. Hepato-gastroenterology 37(4): 376-381, 1990.
11. Vazquez-Sequeiros E, Norton ID, Clain JE, et al.: Impact of EUS-guided fine-needle aspiration on lymph node staging in patients with esphogeal cancer. Gastrointestinal Endoscopy 53(7): 751-757, 2001.
12. Bonavina L, Incarbone R, Lattuada E, et al.: Preoperative laparoscopy in management of patients with carcinoma of the esophagus and of the esophagogastric junction. Journal of Surgical Oncology 65(3): 171-174, 1997.
13. Sugarbaker DJ, Jaklitsch MT, Liptay MJ: Thoracoscopic staging and surgical therapy for esophageal cancer. Chest 107(suppl 6): 218S-223S, 1995.
14. Luketich JD, Schauer P, Landreneau R, et al.: Minimally invasive surgical staging is superior to endoscopic ultrasound in detecting lymph node metastases in esophageal cancer. Journal of Thoracic and Cardiovascular Surgery 114(5): 817-823, 1997.
15. Flamen P, Lerut A, Van Cutsem E, et al.: Utility of positron emission tomography for the staging of patients with potentially operable esophageal carcinoma. Journal of Clinical Oncology 18(18): 3202-3210, 2000.

CELLULAR CLASSIFICATION

Gastrointestinal stromal tumors can occur in the esophagus and are usually benign. (Refer to the PDQ summary on Adult Soft Tissue Sarcoma Treatment for more information.)

STAGE INFORMATION

TNM definitions

TX: Primary tumor cannot be assessed
T0: No evidence of primary tumor
Tis: Carcinoma in situ
T1: Tumor invades lamina propria or submucosa
T2: Tumor invades muscularis propria
T3: Tumor invades adventitia
T4: Tumor invades adjacent structures

NX: Regional lymph nodes cannot be assessed
N0: No regional lymph node metastasis
N1: Regional lymph node metastasis

MX: Distant metastasis cannot be assessed
M0: No distant metastasis
M1: Distant metastasis

Tumors of the lower thoracic esophagus:

M1a: Metastasis in celiac lymph nodes
M1b: Other distant metastasis

Tumors of the midthoracic esophagus:

M1a: Not applicable
M1b: Nonregional lymph nodes and/or other distant metastasis

Tumors of the upper thoracic esophagus:

M1a: Metastasis in cervical nodes
M1b: Other distant metastasis

AJCC stage groupings

Stage 0

Tis, N0, M0

Stage I

T1, N0, M0

Stage IIA

T2, N0, M0
T3, N0, M0

Stage IIB

T1, N1, M0
T2, N1, M0

Stage III

T3, N1, M0
T4, Any N, M0

Stage IV

Any T, Any N, M1

Stage IVA

Any T, Any N, M1a

Stage IVB

Any T, Any N, M1b

References:

1. Esophagus. In: American Joint Committee on Cancer: AJCC Cancer Staging Manual. Philadelphia, Pa: Lippincott-Raven Publishers, 5th ed., 1997, pp 65-69.
2. Parameters linked to ten-year survival in Japan of resected esophageal carcinoma. Japanese Committee for Registration of Esophageal Carcinoma Cases. Chest 96(5): 1005-1011, 1989.
3. Korst RJ, Rusch VW, Venkatraman E, et al.: Proposed revision of the staging classification for esophageal cancer. Journal of Thoracic and Cardiovascular Surgery 115(3): 660-670, 1998.

TREATMENT OPTION OVERVIEW

In the presence of complete esophageal obstruction, without clinical evidence of systemic metastasis, surgical excision of the tumor with mobilization of the stomach to replace the esophagus has been the traditional means of relieving the dysphagia. In the United States, the median age of patients who present with esophageal cancer is 67 years of age.[2] The results of a retrospective review of 505 consecutive patients who were operated on by a single surgical team over 17 years found no difference in the perioperative mortality, median survival, or palliative benefit of esophagectomy on dysphagia when the group of patients older than 70 were compared to their younger peers.[3][Levels of evidence: 3iiA, 3iiB] All of the patients in this series were selected for surgery based on potential operative risk. Age alone should not determine therapy for patients with potentially resectable disease.

There is controversy as to the optimal surgical procedure. One approach advocates transhiatal esophagectomy with anastomosis of the stomach to the cervical esophagus. A second approach advocates abdominal mobilization of the stomach and transthoracic excision of the esophagus with anastomosis of the stomach to the upper thoracic esophagus or the cervical esophagus. In patients with partial esophageal obstruction, dysphagia may, at times, be relieved by placement of an expandable metallic stent [4] or by radiation therapy if the patient has disseminated disease or is not a candidate for surgery. Alternative methods of relieving dysphagia have been reported, including laser therapy and electrocoagulation to destroy intraluminal tumor.[5-8]

Surgical treatment of resectable esophageal cancers results in 5-year survival rates of 5% to 20%, with higher survival rates in patients with early stage cancers. This is associated with a less than 10% operative mortality rate.[9] In an attempt to avoid this perioperative mortality and to relieve dysphagia, definitive radiation therapy in combination with chemotherapy has been studied. One series from Fox Chase, evaluating radiation therapy and chemotherapy with fluorouracil and mitomycin, produced a 75% local control rate, associated with improved swallowing, and a 30% actuarial disease-free survival (18% overall survival) at 5 years for stage I and stage II patients.[10] An Intergroup randomized trial, Radiation Therapy Oncology Group (RTOG) 85-01, of chemotherapy and radiation therapy versus radiation therapy alone resulted in an improvement in 5-year survival for the combined modality group (27% versus 0%).[11][Level of evidence: 1iiA] Eight-year follow-up of this trial demonstrated an overall survival rate of 22% for patients receiving chemotherapy.[12] An Eastern Cooperative Oncology Group trial of 135 patients showed that chemotherapy plus radiation provided a better 2-year survival rate than radiation therapy alone,[13] similar to that shown in the Intergroup trial.[11][Level of evidence: 1iiA] In an attempt to improve upon the results of RTOG 85-01, Intergroup 0123 (RTOG 94-05) randomized 236 patients with localized esophageal tumors to chemoradiation with high-dose radiation therapy (64.5 Gy) and 4 monthly cycles of 5-FU with the same chemotherapy schedule.[14] No statistical differences were observed between the high-dose and conventional-dose radiation therapy arms in median survival (13 months versus 18 months), 2-year survival (31% versus 40%), or local/regional failures (56% versus 52%).[14][Level of evidence: 1iiA] Although originally designed to accrue 298 patients, this trial was closed in 1999 after a planned interim analysis showed that it was statistically unlikely that there would be any advantage using high-dose radiation. A number of phase II studies have suggested improved survival with induction chemoradiotherapy followed by resection when compared with surgery-only historical controls.[15-21] Approximately 25% of patients achieve a complete pathologic response, albeit in some series at the cost of increased postoperative morbidity and mortality.

Phase III trials have compared preoperative concurrent chemoradiotherapy to surgery alone for patients with esophageal cancer.[22-24] A multicenter prospective randomized trial in which preoperative combined chemotherapy (cisplatin) and radiation therapy (3,700 cGy in 370 cGy fractions) followed by surgery was compared to surgery alone in patients with squamous cell carcinoma, showed no improvement in overall survival and a significantly higher postoperative mortality (12% versus 4%) in the combined modality arm.[22] In patients with adenocarcinoma of the esophagus, a single institution phase III trial demonstrated a modest survival benefit (16 months versus 11 months) for patients treated with induction chemoradiotherapy consisting of 5-fluorouracil, cisplatin, and 4,000 cGy (267 cGy fractions) plus surgery over resection alone.[23] Finally, a single institution trial randomized patients (75% with adenocarcinoma) to 5-fluorouracil, cisplatin, vinblastine, and radiation therapy (1.5 Gy twice daily to a total of 45 Gy) plus resection versus esophagectomy alone.[24] At a median follow-up of over 8 years, there was no significant difference between the surgery alone and combined modality therapy with respect to median survival (17.6 months versus 16.9 months), overall survival (16% versus 30% at 3 years), or disease-free survival (16% versus 28% at 3 years). Based on the results of these 3 prospective randomized trials, preoperative chemoradiotherapy should still be considered under clinical evaluation.

Two randomized trials have also shown no significant overall survival benefit for postoperative radiation therapy over surgery alone.[25,26] All newly diagnosed patients should be considered candidates for new therapies and clinical trials comparing various treatment modalities.

Special attention to nutritional support is indicated in any patient undergoing treatment of esophageal cancer.

The designations in PDQ that treatments are "standard" or "under clinical evaluation" are not to be used as a basis for reimbursement determinations.

References:

1. Lerut T, Coosemans W, Van Raemdonck D, et al.: Surgical treatment of Barrett's carcinoma: correlations between morphologic findings and prognosis. Journal of Thoracic and Cardiovascular Surgery 107(4): 1059-1066, 1994.
2. Ginsberg RJ: Cancer treatment in the elderly. Journal of the American College of Surgeons 187(4): 427-428, 1998.
3. Ellis FH Jr, Williamson WA, Heatley GJ: Cancer of the esophagus and cardia: does age influence treatment selection and surgical outcomes? Journal of the American College of Surgeons 187(4): 345-351, 1998.
4. Saxon RR, Morrison KE, Lakin PC, et al.: Malignant esophageal obstruction and esophagorespiratory fistula: palliation with a polyethylene-covered Z-stent. Radiology 202(2): 349-354, 1997.
5. Campbell WR, Taylor SA, Pierce GE, et al.: Therapeutic alternatives in patients with esophageal cancer. American Journal of Surgery 150(6): 665-668, 1985.
6. Mellow MH, Pinkas H: Endoscopic therapy for esophageal carcinoma with Nd:Yag laser: prospective evaluation of efficacy, complications, and survival. Gastrointestinal Endoscopy 30(6): 334-339, 1984.
7. Fleischer D, Sivak MV: Endoscopic Nd-YAG laser therapy as palliation for esophagogastric cancer: parameters affecting initial outcome. Gastroenterology 89(4): 827-831, 1985.
8. Karlin DA, Fisher RS, Krevsky B: Prolonged survival and effective palliation in patients with squamous cell carcinoma of the esophagus following endoscopic laser therapy. Cancer 59(11): 1969-1972, 1987.
9. Kelsen DP, Bains M, Burt M: Neoadjuvant chemotherapy and surgery of cancer of the esophagus. Seminars in Surgical Oncology 6(5): 268-273, 1990.
10. Coia LR, Engstrom PF, Paul AR, et al.: Long-term results of infusional 5-FU, mitomycin-C, and radiation as primary management of esophageal carcinoma. International Journal of Radiation Oncology, Biology, Physics 20(1): 29-36, 1991.
11. Cooper JS, Guo MD, Herskovic A, et al.: Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG-85-01). JAMA: Journal of the American Medical Association 281(17): 1623-1627, 1999.
12. Cooper JS, Guo MD, Herskovic A, et al.: Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG-85-01). JAMA: Journal of the American Medical Association 281(17): 1623-1627, 1999.
13. Smith TJ, Ryan LM, Douglass HO Jr., et al.: Combined chemoradiotherapy vs. radiotherapy alone for early stage squamous cell carcinoma of the esophagus: a study of the Eastern Cooperative Oncology Group. International Journal of Radiation Oncology, Biology, Physics 42(2): 269-276, 1998.
14. Minsky BD, Pajak TF, Ginsberg RJ, et al.: INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. Journal of Clinical Oncology 20(5): 1167-1174, 2002.
15. Forastiere AA, Orringer MB, Perez-Tamayo C, et al.: Preoperative chemoradiation followed by transhiatal esophagectomy for carcinoma of the esophagus: final report. Journal of Clinical Oncology 11(6): 1118-1123, 1993.
16. Poplin E, Fleming T, Leichman L, et al.: Combined therapies for squamous cell carcinoma of the esophagus, a Southwest Oncology Group Study (SWOG-8037). Journal of Clinical Oncology 5(4): 622-628, 1987.
17. Stewart JR, Hoff SJ, Johnson DH, et al.: Improved survival with neoadjuvant therapy and resection for adenocarcinoma of the esophagus. Annals of Surgery 218(4): 571-578, 1993.
18. Urba SG, Orringer MB, Perez-Tamayo C, et al.: Concurrent preoperative chemotherapy and radiation therapy in localized esophageal adenocarcinoma. Cancer 69(2): 285-291, 1992.
19. Stahl M, Wilke H, Fink U, et al.: Combined preoperative chemotherapy and radiotherapy in patients with locally advanced esophageal cancer: interim analysis of a phase II trial. Journal of Clinical Oncology 14(3): 829-837, 1996.
20. Bates BA, Detterbeck FC, Bernard SA, et al.: Concurrent radiation therapy and chemotherapy followed by esophagectomy for localized esophageal carcinoma. Journal of Clinical Oncology 14(1): 156-163, 1996.
21. Lew JI, Gooding WE, Ribeiro U, et al.: Long-term survival following induction chemoradiotherapy and esphagectomy for esophageal carcinoma. Archives of Surgery 136(7): 737-742, 2001.
22. Bosset JF, Gignoux M, Triboulet JP, et al.: Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus. New England Journal of Medicine 337(3): 161-167, 1997.
23. Walsh TN, Noonan N, Hollywood D, et al.: A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. New England Journal of Medicine 335(7): 462-467, 1996.
24. Urba SG, Orringer MB, Turrisi A, et al.: Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. Journal of Clinical Oncology 19(2): 305-313, 2001.
25. Teniere P, Hay JM, Fingerhut A, et al.: Postoperative radiation therapy does not increase survival after curative resection for squamous cell carcinoma of the middle and lower esophagus as shown by a multicenter controlled trial. French University Association for Surgical Research. Surgery, Gynecology and Obstetrics 173(2): 123-130, 1991.
26. Fok M, Sham JS, Choy D, et al.: Postoperative radiotherapy for carcinoma of the esophagus: a prospective, randomized controlled study. Surgery 113(2): 138-147, 1993.

STAGE 0 ESOPHAGEAL CANCER

References:

1. Rusch VW, Levine DS, Haggitt R, et al.: The management of high grade dysplasia and early cancer in Barrett's esophagus. A multidisciplinary problem. Cancer 74(4): 1225-1229, 1994.
2. Heitmiller RF, Redmond M, Hamilton SR: Barrett's esophagus with high-grade dysplasia. An indication for prophylactic esophagectomy. Annals of Surgery 224(1): 66-71, 1996.

STAGE I ESOPHAGEAL CANCER

Surgery.

Treatment options under clinical evaluation:

Clinical trials as outlined in treatment overview. Information about ongoing clinical trials is available from the NCI (Http: //cancer.gov/clinical_trials).

STAGE II ESOPHAGEAL CANCER

Surgery.

Treatment options under clinical evaluation:

Chemotherapy plus radiation therapy with or without subsequent surgery.[1,2] Information about ongoing clinical trials is available from the NCI (Http: //cancer.gov/clinical_trials).

References:

1. Cooper JS, Guo MD, Herskovic A, et al.: Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG-85-01). JAMA: Journal of the American Medical Association 281(17): 1623-1627, 1999.
2. Herskovic A, Al-Sarraf M: Combination of 5-fluorouracil and radiation in esophageal cancer. Seminars in Radiation Oncology 7(4): 283-290, 1997.

STAGE III ESOPHAGEAL CANCER

Surgical resection of T3 lesions.

Treatment options under clinical evaluation:

Chemotherapy plus radiation therapy with or without subsequent surgery.[1,2] Information about ongoing clinical trials is available from the NCI (Http: //cancer.gov/clinical_trials).

References:

1. Cooper JS, Guo MD, Herskovic A, et al.: Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG-85-01). JAMA: Journal of the American Medical Association 281(17): 1623-1627, 1999.
2. Herskovic A, Al-Sarraf M: Combination of 5-fluorouracil and radiation in esophageal cancer. Seminars in Radiation Oncology 7(4): 283-290, 1997.

STAGE IV ESOPHAGEAL CANCER

Standard treatment options:

1. Endoscopic-placed stents to provide palliation of dysphagia.[2]

2. Radiation therapy with or without intraluminal intubation and dilation.

3. Intraluminal brachytherapy can also provide palliation of dysphagia.[3,4]

4. Nd:YAG endoluminal tumor destruction or electrocoagulation.[5]

5. Chemotherapy has provided partial responses for patients with metastatic
distal esophageal adenocarcinomas.[6,7]

Treatment options under clinical evaluation:

Many agents are active in esophageal cancer. Objective response rates of 30% to 50% and median survivals of less than 1 year are commonly reported with platinum-based combination regimens with fluorouracil, taxanes, or topoisomerase inhibitors.[1] The HLFP regimen (5-FU and cisplatin in combination with hydroxyurea and leucovorin) has resulted in objective response rates of 57% and a median overall survival rate of 12.7 months.[8]

Clinical trials evaluating single-agent or combination chemotherapy. Information about ongoing clinical trials is available from the NCI (Http: //cancer.gov/clinical_trials).

References:

1. Enzinger PC, Ilson DH, Kelsen DP: Chemotherapy in esophageal cancer. Seminars in Oncology 26(5, suppl 15): 12-20, 1999.
2. Baron TH: Expandable metal stents for the treatment of cancerous obstruction of the gastrointestinal tract. New England Journal of Medicine 344(22): 1681-1687, 2001.
3. Sur RK, Levin CV, Donde B, et al.: Prospective randomized trial of HDR brachytherapy as a sole modality in palliation of advanced esophageal carcinoma--an International Atomic Energy Agency study. International Journal of Radiation Oncology, Biology, Physics 53(1): 127-133, 2002.
4. Gaspar LE, Nag S, Herskovic A, et al.: American Brachytherapy Society (ABS) consensus guidelines for brachytherapy of esophageal cancer. International Journal of Radiation Oncology, Biology, Physics 38(1): 127-132, 1997.
5. Bourke MJ, Hope RL, Chu G, et al.: Laser palliation of inoperable malignant dysphagia: initial and at death. Gastrointestinal Endoscopy 43(1): 29-32, 1996.
6. Waters JS, Norman A, Cunningham D, et al.: Long-term survival after epirubicin, cisplatin and fluorouracil for gastric cancer: results of a randomized trial. British Journal of Cancer 80(1/2): 269-272, 1999.
7. Ross P, Nicolson M, Cunningham D, et al.: Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. Journal of Clinical Oncology 20(8): 1996-2004, 2002.
8. Taieb J, Artru P, Baujat B, et al.: Optimisation of 5-fluorouracil (5-FU)/cisplatin combination chemotherapy with a new schedule of hydroxyurea, leucovorin, 5-FU and cisplatin (HLFP regimen) for metastatic oesophageal cancer. European Journal of Cancer 38(5): 661-666, 2002.

RECURRENT ESOPHAGEAL CANCER

Standard treatment options:

Palliative use of any of the standard therapies, including supportive care.

Treatment options under clinical evaluation:

Clinical trials as outlined in treatment overview. Information about ongoing clinical trials is available from the NCI (Http: //cancer.gov/clinical_trials).

Date Last Modified: 11/2002

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