Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus

This study has been terminated.
(completed administratively due to poor acrual)
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003118
First received: November 1, 1999
Last updated: September 27, 2013
Last verified: September 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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 Alliance for Clinical Trials in Oncology:

Estimated Enrollment: 500
Study Start Date: October 1997
Study Completion Date: March 2000
Estimated Primary Completion Date: March 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy + Radiation + Surgery Drug: cisplatin Drug: fluorouracil Procedure: surgical procedure Radiation: radiation therapy
Active Comparator: Surgery Procedure: surgical procedure

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 38 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
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

Publications:
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.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003118     History of Changes
Other Study ID Numbers: CDR0000065873, U10CA031946, CLB-C9781, E-C9781, NCCTG-C9781, RTOG-9716
Study First Received: November 1, 1999
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus

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

ClinicalTrials.gov processed this record on September 16, 2014