Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer - Full Text View

Sponsors and Collaborators:	Federation Francophone de Cancerologie Digestive Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) European Organization for Research and Treatment of Cancer Federation Nationale des Centres de Lutte Contre le Cancer Societe Francaise de Radiotherapie Oncologique
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00047112

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 Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Cisplatin Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable

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

Study Start Date:

May 2002

Detailed Description:

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

Sponsors and Collaborators

Federation Francophone de Cancerologie Digestive

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

European Organization for Research and Treatment of Cancer

Federation Nationale des Centres de Lutte Contre le Cancer

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	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Study Chair:	Francoise Mornex, MD, PhD	Centre Hospitalier Lyon Sud

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 23, 2008
ClinicalTrials.gov Identifier:	NCT00047112
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

Study placed in the following topic categories:

Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Squamous cell carcinoma
Carcinoma
Epidermoid carcinoma
Digestive System Diseases
Cisplatin

Fluorouracil
Head and Neck Neoplasms
Carcinoma, squamous cell
Gastrointestinal Neoplasms
Esophageal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma
Esophageal neoplasm

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009