Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00766480
Other study ID # CDR0000615602
Secondary ID TOYAMAU-TRIEC060
Status Recruiting
Phase N/A
First received October 3, 2008
Last updated August 23, 2013
Start date January 2007

Study information

Verified date July 2009
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility 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

Study Design

Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
cisplatin
Given IV
fluorouracil
Given IV
Radiation:
radiation therapy
Patients undergo radiotherapy

Locations

Country Name City State
Japan National Kyushu Cancer Center Fukuoka
Japan Hiroshima City Asa Hospital Hiroshima
Japan Kagoshima University Kagoshima
Japan National Cancer Center Hospital East Kashiwa Chiba
Japan Kawasaki Medical School Kurashiki Okayama
Japan Kurume University School of Medicine Kurume Fukuoka
Japan Kyoto University Hospital Kyoto
Japan Gunma University Graduate School of Medicine Maebashi-shi Gunma
Japan Iwate Medical University Hospital Morioka Iwate
Japan Aichi Cancer Center Nagoya Aichi
Japan Niigata Cancer Center Hospital Niigata
Japan Niigata University Medical and Dental Hospital Niigata
Japan Graduate School of Medical Science at the University of Ryukyu Nishiharacho Okinawa
Japan Hyogo College of Medicine Nishinomiya Hyogo
Japan Osaka Medical Center for Cancer and Cardiovascular Diseases Osaka
Japan Kinki University School of Medicine Osakasayama Osaka
Japan Osaka University Graduate School of Medicine Suita Osaka
Japan Mita Hospital at the International University of Health and Welfare Tokyo
Japan Tokyo Women's Medical University Tokyo
Japan Toyama University Hospital Toyama

Sponsors (1)

Lead Sponsor Collaborator
University of Toyama

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1-year progression-free survival No
Primary 1-year local progression-free survival No
Primary 3-year progression-free survival No
Primary 3-year overall survival No
Primary Complete histological response No
See also
  Status Clinical Trial Phase
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
Not yet recruiting NCT05542680 - Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer N/A
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Completed NCT00003864 - Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus Phase 2
Recruiting NCT05491616 - Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Completed NCT03756597 - PAN-study: Pan-Cancer Early Detection Study (PAN)
Completed NCT00400114 - Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT04615806 - The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy N/A
Active, not recruiting NCT04566367 - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer N/A
Active, not recruiting NCT03962179 - Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent) N/A
Terminated NCT01446874 - Prevention of Post-operative Pneumonia (POPP) Phase 2/Phase 3
Completed NCT03468634 - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy N/A
Active, not recruiting NCT02869217 - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors Phase 1
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT02544737 - Apatinib for Metastatic Esophageal Cancer. Phase 2