Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Under 75 Other FFCD-9901 EORTC-22001, EORTC-40001, FRE-FNCLCC-FFCD-9901, FRE-GERCOR-FFCD-9901, SFRO-FFCD-9901, EU-20215, NCT00047112

Objectives

1. Compare the overall survival of patients with resectable thoracic esophageal cancer treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone.
2. Compare the disease-free survival of patients treated with these regimens.
3. Compare the surgical mortality and morbidity of patients treated with these regimens.
4. Compare the resectability of patients treated with these regimens.
5. Determine the validation of new prognostic factors for survival of these patients and/or the efficacy of this neoadjuvant treatment.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• Under 75

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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 O₂ greater than 60 mm Hg
• Arterial CO₂ 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

• FEV₁ 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

Expected Enrollment

A total of 380 patients (190 per treatment arm) will be accrued for this study within 3 years.

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.

Trial Contact Information

Trial Lead Organizations

Federation Francophone de Cancerologie Digestive

J. Triboulet, Protocol chair		Ph: 33-3-20-44-42-04

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Gerard Ganem, MD, Protocol chair		Ph: 334-339-1300

European Organization for Research and Treatment of Cancer

Jean-Francois Bosset, MD, Study coordinator		Ph: 33-381-668310 Email: jean-francois.bosset@ufc-chu.univ-fcomte.fr
Thierry Conroy, MD, Study coordinator		Ph: 33-3-8359-8460

Federation Nationale des Centres de Lutte Contre le Cancer

Jean-Francois Seitz, MD, Protocol chair		Ph: 33-4-9122-3302

Societe Francaise de Radiotherapie Oncologique

Francoise Mornex, MD, PhD, Protocol chair		Ph: 33-478-864-253 Email: francoise.mornex@chu-lyon.fr

Registry Information
Official Title		Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable
Trial Start Date		2002-05-17
Registered in ClinicalTrials.gov		NCT00047112
Date Submitted to PDQ		2002-07-10
Information Last Verified		2005-02-23

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