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Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047112
First Posted: January 27, 2003
Last Update Posted: May 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 (Responsible Party):
Federation Francophone de Cancerologie Digestive
  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
Intervention Model: Parallel Assignment
Masking: None (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 Federation Francophone de Cancerologie Digestive:

Primary Outcome Measures:
  • overal survival [ Time Frame: 2010 ]

Secondary Outcome Measures:
  • recurrence free survival [ Time Frame: 2010 ]

Enrollment: 195
Study Start Date: May 2002
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy
Active Comparator: CHIRURGIE SEULE
CHIRURGIE SEULE
Procedure: conventional surgery

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 74 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047112


  Show 73 Study Locations
Sponsors 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: Jean-Francois Seitz, MD Institut Paoli-Calmettes
  More 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Federation Francophone de Cancerologie Digestive
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
First Submitted: October 3, 2002
First Posted: January 27, 2003
Last Update Posted: May 30, 2016
Last Verified: May 2016

Keywords provided by Federation Francophone de Cancerologie Digestive:
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage I esophageal cancer
stage II esophageal cancer

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
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs