Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2005 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Federation Francophone de Cancerologie Digestive
Collaborators:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
European Organisation for Research and Treatment of Cancer - EORTC
UNICANCER
Societe Francaise de Radiotherapie Oncologique
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00047112
First received: October 3, 2002
Last updated: July 20, 2010
Last verified: February 2005
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | May 2002 |
OBJECTIVES:
- Compare the overall survival of patients with resectable thoracic esophageal cancer treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone.
- Compare the disease-free survival of patients treated with these regimens.
- Compare the surgical mortality and morbidity of patients treated with these regimens.
- Compare the resectability of patients treated with these regimens.
- Determine the validation of new prognostic factors for survival of these patients and/or the efficacy of this neoadjuvant treatment.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to histology (epidermoid carcinoma vs adenocarcinoma vs undifferentiated carcinoma), stage (I vs IIA vs IIB), tumor location (above the carina vs below the carina), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy daily 5 days a week for 5 weeks. Patients receive fluorouracil IV continuously on days 1-4 and 29-32 and cisplatin IV on days 1 or 2 and 29 or 30 (or a lower dose on days 1-5 and 29-33). Within 4-8 weeks after completion of radio-chemotherapy, patients undergo surgical resection.
- Arm II: Patients undergo surgical resection. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 380 patients (190 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | up to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of stage I or II thoracic esophageal cancer
- Tumor no greater than 3 cm with no invasion of mediastinal structures with or without extension to the lymph nodes (T1-2, N0-1, M0) OR
- Tumor greater than 3 cm with no invasion of mediastinal structures and no adenopathy greater than 1 cm (T3, N0, M0)
- Epidermoid carcinoma or adenocarcinoma
- Previously untreated
- Deemed resectable with curative intent
- No carcinoma in situ
- No small cell anaplastic carcinoma (i.e., chromogranin negative)
- No small cell neuroendocrine carcinoma (i.e., chromogranin positive)
- No multifocal esophageal carcinoma (i.e., 2 or more distinct lesions 5 or more cm apart)
- No involvement of the pharyngoesophageal junction and the first 4 cm of the esophagus (i.e., where the proximal edge of the tumor is less than 19 cm from the dental arch)
- No evidence of extension to the tracheobronchial tree at endoscopy, ultrasound, or CT scan (simple compression allowed)
- No signs of mediastinal involvement on CT scan
- No palpable subclavicular lymph nodes or involvement after cytology needle aspiration
No lymph nodes from the origin of the celiac greater than 1 cm on CT scan
- Perigastric lymph nodes far from the celiac trunk and deemed resectable allowed unless tumor is more than 30 mm on CT scan
PATIENT CHARACTERISTICS:
Age
- Under 75
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- SGOT/SGPT ratio no greater than 1
- Albumin at least 35 g/L
- Total protein greater than 80%
- No liver cirrhosis with previous failure
- No ascites
- No jaundice
- No rupture of varicose esophageal veins
- No presence of varicose esophageal veins
Renal
- Creatinine no greater than 1.25 times normal
Cardiovascular
- Arterial O_2 greater than 60 mm Hg
- Arterial CO_2 no greater than 45 mm Hg
- No myocardial infarction within the past 6 months
- No progressive coronary artery disease grade 2 or greater
- No recent left ventricular failure
- No arterial disease stage II-IV
Pulmonary
- FEV_1 greater than 1 L/sec
Other
- Able to receive either study treatment
- No recurrent paralysis
- No weight loss greater than 10% from baseline
- No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant
- Fertile patients must use effective contraception during and for 3 months after completion of chemotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047112
Show 73 Study Locations
Show 73 Study LocationsSponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
European Organisation for Research and Treatment of Cancer - EORTC
UNICANCER
Societe Francaise de Radiotherapie Oncologique
Investigators
| Study Chair: | J. P. Triboulet | Centre Hospitalier Regional et Universitaire de Lille |
| Study Chair: | Gerard Ganem, MD | Centre Jean Bernard |
| Investigator: | Jean-Francois Bosset, MD | Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz |
| Investigator: | Thierry Conroy, MD | Centre Alexis Vautrin |
| Study Chair: | Jean-Francois Seitz, MD | Institut Paoli-Calmettes |
| Study Chair: | Francoise Mornex, MD, PhD | Centre Hospitalier Lyon Sud |
More Information
Additional Information:
Publications:
Mariette C, Seitz JF, Maillard E, et al.: Surgery alone versus chemoradiotherapy followed by surgery for localized esophageal cancer: analysis of a randomized controlled phase III trial FFCD 9901. [Abstract] J Clin Oncol 28 (Suppl 15): A-4005, 2010.
| ClinicalTrials.gov Identifier: | NCT00047112 History of Changes |
| Other Study ID Numbers: | CDR0000257600, FFCD-9901, EORTC-22001, EORTC-40001, FRE-FNCLCC-FFCD-9901, FRE-GERCOR-FFCD-9901, SFRO-FFCD-9901, EU-20215 |
| Study First Received: | October 3, 2002 |
| Last Updated: | July 20, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage I esophageal cancer stage II esophageal cancer |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Cisplatin Fluorouracil |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013