Study of Tissue Samples in Predicting How Well Chemotherapy and Radiation Therapy Will Kill Cancer Cells in Patients With Squamous Cell Carcinoma of the Esophagus

University of Toyama

Status: Unknown

Conditions: Esophageal Cancer

Treatments: Drug: fluorouracil; Radiation: radiation therapy; Drug: cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00766480

TOYAMAU-TRIEC0601

CDR0000615602

Details and patient eligibility

About

RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying tissue samples in predicting how well chemotherapy and radiation therapy will kill cancer cells in patients with squamous cell carcinoma of the esophagus.

Full description

OBJECTIVES:

• To search for chemoradiosensitivity-related genes using a pre-treatment biopsy sample in patients with esophageal squamous cell carcinoma treated with cisplatin, fluorouracil, and concurrent radiotherapy.
• To establish an algorithm for prediction of chemoradiosensitivity in these patients.

OUTLINE: Patients receive 1 of the following treatment regimens:

• Regimen 1: Patients receive low-dose cisplatin IV on days 1 and 29 and low-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy on days 1-4 and 29-32. Patients undergo salvage surgery if needed.
• Regimen 2: Patients receive high-dose cisplatin IV on days 1 and 29 and high-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy and salvage surgery as in regimen 1.

Pre-operative biopsy samples are analyzed by DNA microarray chip to establish an algorithm for prediction of chemoradiosensitivity.

After completion of study therapy, patients are followed at 12 months.

Enrollment: 160 estimated patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the thoracic esophagus

  • Stage IIA, IIB, or III (except T4) disease
  • Tumor diameter < 8 cm

• No tumor extension to the cervical esophagus or cardia of the stomach

• No multiple and different histological types of cancer

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• WBC ≥ 4,000/mm³
• Absolute neutrophil count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL
• AST and ALT ≤ 100 IU/L
• Total serum bilirubin ≤ 1.5 mg/dL
• Creatinine ≤ 1.2 mg/dL
• Creatinine clearance ≥ 60mL/min
• SpO_2 (room air) ≥ 95%
• Not pregnant or nursing
• No abnormal ECG findings requiring treatment
• No interstitial pneumonitis or no pulmonary fibrosis
• No severe complication (e.g., heart failure, renal failure, hepatic failure, or uncontrollable diabetes mellitus)
• No collagen disease (e.g., PSS or dermatomyositis)
• No mental disease
• No active bacterial infection
• No virus infection (i.e., HBV, HCV, PTHA, or HIV)

PRIOR CONCURRENT THERAPY:

• No prior surgery for esophageal cancer
• No prior chemotherapy
• No prior chest radiotherapy

Trial design

160 participants in 2 patient groups

Regimen 1

Experimental group

Description:

Patients receive low-dose cisplatin IV on days 1 and 29 and low-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy on days 1-4 and 29-32. Patients undergo salvage surgery if needed.

Treatment:

Radiation: radiation therapy

Drug: cisplatin

Drug: fluorouracil

Regimen 2

Experimental group

Description:

Patients receive high-dose cisplatin IV on days 1 and 29 and high-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy and salvage surgery as in regimen 1.

Treatment:

Radiation: radiation therapy

Drug: cisplatin

Drug: fluorouracil