Clinical trial NCT00766480: 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
Official title: An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: squamous cell carcinoma of the esophagus
stage IIA esophageal cancer
stage IIB esophageal cancer
stage IIIA esophageal cancer
stage IIIB esophageal cancer
stage IIIC esophageal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-10-06
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: 1-year progression-free survival
measure: 1-year local progression-free survival
measure: 3-year progression-free survival
measure: 3-year overall survival
measure: Complete histological response
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Kurume
country: Japan
facility: Kurume University School of Medicine
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Gunma University Graduate School of Medicine
state: Gunma
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Kurashiki
country: Japan
facility: Kawasaki Medical School
state: Okayama
city: Nishiharacho
country: Japan
facility: Graduate School of Medical Science at the University of Ryukyu
state: Okinawa
city: Osakasayama
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Suita
country: Japan
facility: Osaka University Graduate School of Medicine
state: Osaka
city: Fukuoka
country: Japan
facility: National Kyushu Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Asa Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
city: Tokyo
country: Japan
facility: Mita Hospital at the International University of Health and Welfare
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
city: Toyama
country: Japan
facility: Toyama University Hospital
Study officials:
affiliation: University of Toyama
name: Yutaka Shimada, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: