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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
Sponsor:
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
History of Changes

October 3, 2002
July 20, 2010
May 2002
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Complete list of historical versions of study NCT00047112 on ClinicalTrials.gov Archive Site
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Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable

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.

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.
Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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
Both
up to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Netherlands
 
NCT00047112
CDR0000257600, FFCD-9901, EORTC-22001, EORTC-40001, FRE-FNCLCC-FFCD-9901, FRE-GERCOR-FFCD-9901, SFRO-FFCD-9901, EU-20215
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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
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
National Cancer Institute (NCI)
February 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP