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Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003118
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy and radiation therapy for cancer of the esophagus.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy and radiation therapy in treating patients who have cancer of the esophagus that can be surgically removed.


Condition Intervention Phase
Esophageal Cancer
Drug: cisplatin
Drug: fluorouracil
Procedure: surgical procedure
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Prospective Randomized Phase III Trial Comparing Trimodality Therapy (Cisplatin, 5-FU, Radiotherapy, and Surgery) to Surgery Alone for Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 500
Study Start Date: October 1997
Detailed Description:

OBJECTIVES: I. Compare overall five-year survival rates and treatment failures in patients receiving neoadjuvant cisplatin (CDDP) plus fluorouracil (5-FU) with concomitant radiotherapy followed by surgical resection versus patients receiving surgery alone. II. Assess and compare the toxicities of each approach. III. Compare the incidence and pattern of local (gastric or esophageal bed or regional lymph nodes) and distant (supraclavicular lymph node, liver, peritoneal carcinomatosis, or lung, brain, etc.) recurrence. IV. Evaluate the prognostic ability of noninvasive and minimally invasive pretreatment staging with regard to survival and recurrence. V.

Evaluate the ability of preresection adjuvant chemotherapy with concomitant radiation therapy to render tumors to lower stages. VI. Evaluate the impact of lymph nodes on survival and recurrence.

OUTLINE: This a two arm, randomized study. Patients are stratified by: cell type of cancer (squamous cell vs adenocarcinoma); lymph nodes (positive vs negative); and stage (invasive vs noninvasive). Patients in arm I undergo chemotherapy and radiotherapy within 24 hours of each other. Chemotherapy consists of cisplatin (CDDP) by bolus IV infusion over 30 minutes on day 1 and again on day 29. Fluorouracil (5-FU) is administered by continuous IV infusion for 4 days (on days 1-4 and 29-32) after completion of cisplatin. Radiotherapy is administered on days 1-5, 8-12, 15-19, 22-26, and 29-33, with a boost on days 36-38. If there is no disease progression or unresectable disease, surgery is performed within 3-8 weeks following completion of therapy. Patients in arm II undergo surgery alone no later than 6 weeks postrandomization. Patients are followed at least every 3 months for two years, then every 6 months for the next two years, and annually thereafter.

PROJECTED ACCRUAL: There will be 500 patients accrued into this study within 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus or gastroesophageal junction Stages I, IIA, IIB, or III Tumor must be considered surgically resectable No positive supraclavicular nodes (greater than 1.5 cm by CT) or palpable supraclavicular nodes No positive (greater than 1.5 cm by CT) nodes in levels 15-20 Lymph node involvement in levels 15, 16, and 20 that are no greater than 1.5 cm by CT allowed Patient without radiographical evidence of lymph node involvement in levels 15, 16, and 20 that are proven positive at time of presurgical staging also allowed Radiographically positive lymph node involvement in levels 17-19 allowed only if proven to be negative by biopsy No positive lymph node involvement in levels 17-19 even if there was no radiographic evidence of lymph node involvement No tumors with greater than 2 cm distal spread into the gastric cardia No distant metastases (suspicious lesions on CT should be tested by ultrasound, MRI or biopsy)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,800/mm3 Platelet count at least 100,000/mm3 Hepatic: If alkaline phosphatase is greater than 3 times normal, must undergo esophagoscopy with biopsy, barium esophagogram, CT scan of the chest and upper abdomen, and bone scan Renal: Creatinine clearance at least 50 mL/min Other: No other prior malignancy unless disease free for greater than 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this malignancy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy that would overlap the field(s) treated in this study Surgery: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003118

  Show 38 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Eastern Cooperative Oncology Group
Investigators
Study Chair: Mark J. Krasna, MD University of Maryland Greenebaum Cancer Center
Study Chair: Richard M. Goldberg, MD Mayo Clinic
Study Chair: Tyvin A. Rich, MD University of Virginia
Study Chair: Richard H. Feins, MD James P. Wilmot Cancer Center
  More Information

Additional Information:
Publications:
Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III Trial of Trimodality Therapy With Cisplatin, Fluorouracil, Radiotherapy, and Surgery Compared With Surgery Alone for Esophageal Cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92.
Krasna M, Tepper JE, Niedzwiecki D, et al.: Trimodality therapy is superior to surgery alone in esophageal cancer: results of CALGB 9781. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-4, 2006.
Tepper JE, Krasna M, Niedzwiecki D, et al.: Superiority of trimodality therapy to surgery alone in esophageal cancer: results of CALGB 9781. [Abstract] J Clin Oncol 24 (Suppl 18): A-4012, 2006.

Study ID Numbers: CDR0000065873, CLB-C9781, E-C9781, NCCTG-C9781, RTOG-9716
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003118     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus

Study placed in the following topic categories:
Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Squamous Cell Carcinoma
Immunosuppressive Agents
Carcinoma
Digestive System Diseases
Radiation-Sensitizing Agents
Cisplatin
Esophageal Disorder
Fluorouracil
Head and Neck Neoplasms
Epidermoid Carcinoma
Gastrointestinal Neoplasms
Esophageal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Digestive System Neoplasms
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Head and Neck Neoplasms
Fluorouracil
Therapeutic Uses
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on September 01, 2009