Radiation Therapy and Combination Chemotherapy With or Without Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier:
NCT00416858
First received: December 27, 2006
Last updated: March 3, 2014
Last verified: April 2007
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain.

PURPOSE: This randomized phase III trial is studying radiation therapy together with combination chemotherapy to see how well they work with or without surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.


Condition Intervention Phase
Esophageal Cancer
Drug: cisplatin
Drug: fluorouracil
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Study of Adjuvant Radiochemotherapy After Surgery Versus Radiochemotherapy Alone in Patients With Locally Advanced Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Federation Francophone de Cancerologie Digestive:

Estimated Enrollment: 40
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the survival of patients with locally advanced esophageal cancer treated with neoadjuvant radiotherapy and chemotherapy comprising fluorouracil and cisplatin followed by surgery or radiotherapy and chemotherapy.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender, histology (epidermoid vs glandular), response to induction therapy (complete vs partial), and tumor differentiation (little differentiated vs undifferentiated/good vs moderately differentiated).

  • Induction therapy: All patients receive induction therapy comprising fluorouracil IV continuously over 24 hours on days 1-5 and cisplatin IV over 1 hour on days 1-5 or on day 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo radiotherapy twice daily on days 1-5 and 22-26 or once daily 5 days a week for 4½ weeks. Patients achieving complete or partial response are randomized to 1 of 2 treatment arms.
  • Arm I: Patients undergo surgery. Patients may receive 1 course of adjuvant chemotherapy (as in induction therapy) and undergo additional radiotherapy.
  • Arm II: Patients receive additional fluoroucacil and cisplatin as in induction therapy. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo additional radiotherapy once daily 5 days a week for 2 weeks.

Quality of life is assessed at baseline, after treatment on arms I or II, and then every 2 months (arm I) or every 6 months (arm II) thereafter.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed epidermoid or glandular cancer of the esophagus meeting the following criteria:

    • Tumor volume with or without mediastinal adenopathy, celiac, or subclavicular involvement
    • T3, N0-N1 disease
    • Tumor extends into fifth stratum by endosonographic scan
    • Resectable disease (palliative or curative)
  • No cervical tumor
  • No T1, T2, or T4 tumors
  • No tracheo-esophageal fistula or tracheal invasion
  • No gastric cardia cancer by gastroscopy
  • No visceral (e.g., lung, bone, brain, liver), ganglion, or clavicular metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Creatinine normal
  • WBC ≥ 3,000/mm^3
  • Neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Transaminases ≥ 60%
  • Bilirubin ≤ 2.0 mg/dL
  • No cirrhosis
  • DLCO ≥ 1.5 L with or without hypoxemia at rest
  • No progressive coronary insufficiency
  • Weight loss ≤ 15%
  • No other malignancy in the past 2 years
  • Must be able to maintain sufficient enteral nutrition (2,000 calories/day)

    • Laser photodestruction, dilation, or gastric balloon allowed
  • No contraindication to radiotherapy
  • No recurring left paralysis

PRIOR CONCURRENT THERAPY:

  • No concurrent nephrotoxic or myelotoxic drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416858

Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Study Chair: Laurent Bedenne, MD Federation Francophone de Cancerologie Digestive
  More Information

Additional Information:
Publications:
Jouve J, Michel P, Mariette C, et al.: Outcome of the nonrandomized patients in the FFCD 9102 trial: chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus. [Abstract] J Clin Oncol 26 (Suppl 15): A-4555, 2008.

Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT00416858     History of Changes
Other Study ID Numbers: CDR0000453783, FFCD-9102, EU-20539, ESSAI-FFCD-9102
Study First Received: December 27, 2006
Last Updated: March 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Federation Francophone de Cancerologie Digestive:
stage III 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
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014