Trial record 17 of 208 for:
Open Studies | "Esophageal Neoplasms"
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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Toyama University Hospital
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00766480
First received: October 3, 2008
Last updated: January 7, 2010
Last verified: July 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Esophageal Cancer |
Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- 1-year progression-free survival [ Designated as safety issue: No ]
- 1-year local progression-free survival [ Designated as safety issue: No ]
- 3-year progression-free survival [ Designated as safety issue: No ]
- 3-year overall survival [ Designated as safety issue: No ]
- Complete histological response [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: cisplatin
Given IV
Drug: fluorouracil
Given IV
Radiation: radiation therapy
Patients undergo radiotherapy
|
|
Experimental: 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.
|
Drug: cisplatin
Given IV
Drug: fluorouracil
Given IV
Radiation: radiation therapy
Patients undergo radiotherapy
|
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| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766480
Locations
| Japan | |
| Aichi Cancer Center | Recruiting |
| Nagoya, Aichi, Japan, 464-8681 | |
| Contact: Shunzo Hatooka 81-52-762-6111 | |
| National Cancer Center Hospital East | Recruiting |
| Kashiwa, Chiba, Japan, 277-8577 | |
| Contact: Keiko Minashi 81-4-7133-1111 | |
| Kurume University School of Medicine | Recruiting |
| Kurume, Fukuoka, Japan, 830-0011 | |
| Contact: Toshiaki Tanaka 81-942-35-3311 | |
| Gunma University Graduate School of Medicine | Recruiting |
| Maebashi-shi, Gunma, Japan, 371-8511 | |
| Contact: Hiroyuki Kuwano, MD, PhD 81-27-220-8224 hkuwano@med.gunma-u.ac.jp | |
| Hyogo College of Medicine | Recruiting |
| Nishinomiya, Hyogo, Japan, 663-8501 | |
| Contact: Koushi Oh 81-798-45-6582 | |
| Iwate Medical University Hospital | Recruiting |
| Morioka, Iwate, Japan, 020-8505 | |
| Contact: Kenichiro Ikeda 81-19-651-5111 | |
| Kawasaki Medical School | Recruiting |
| Kurashiki, Okayama, Japan, 701-01 | |
| Contact: Toshihiro Hirai 81-86-462-1199 | |
| Graduate School of Medical Science at the University of Ryukyu | Recruiting |
| Nishiharacho, Okinawa, Japan, 903-0215 | |
| Contact: Tadashi Nishimaki 81-98-895-3331 | |
| Kinki University School of Medicine | Recruiting |
| Osakasayama, Osaka, Japan, 589-8511 | |
| Contact: Takushi Yasuda 81-72-366-0221 | |
| Osaka University Graduate School of Medicine | Recruiting |
| Suita, Osaka, Japan, 565-0871 | |
| Contact: Masaichi Ohira 81-6-6645-3837 | |
| National Kyushu Cancer Center | Recruiting |
| Fukuoka, Japan, 811-1395 | |
| Contact: Yasushi Toh, MD, PhD 81-92-541-3231 | |
| Hiroshima City Asa Hospital | Recruiting |
| Hiroshima, Japan, 731-0293 | |
| Contact: Hidenori Mukaida 81-82-815-5211 | |
| Kagoshima University | Recruiting |
| Kagoshima, Japan, 890-8520 | |
| Contact: Shoji Natsugoe 81-99-275-5361 | |
| Kyoto University Hospital | Recruiting |
| Kyoto, Japan, 606-8507 | |
| Contact: Michihide Mitsumori 81-75-751-3417 | |
| Niigata University Medical and Dental Hospital | Recruiting |
| Niigata, Japan, 951-8510 | |
| Contact: Tatsuo Kanda, MD 81-25-227-2228 | |
| Niigata Cancer Center Hospital | Recruiting |
| Niigata, Japan, 951-8566 | |
| Contact: Hiroshi Yabusaki 81-25-266-5111 | |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | Recruiting |
| Osaka, Japan, 537-8511 | |
| Contact: Ryu Ishihara 81-6-6972-1181 | |
| Mita Hospital at the International University of Health and Welfare | Recruiting |
| Tokyo, Japan, 108-8329 | |
| Contact: Ken-ichi Mafune, MD 81-3-3451-8121 mafune@iuhw.ac.jp | |
| Tokyo Women's Medical University | Recruiting |
| Tokyo, Japan, 162-8666 | |
| Contact: Tsutomu Nakamura 81-3-3353-8111 | |
| Toyama University Hospital | Recruiting |
| Toyama, Japan, 930-8555 | |
| Contact: Yutaka Shimada, MD, PhD 81-76-434-7331 | |
Sponsors and Collaborators
Toyama University Hospital
Investigators
| Principal Investigator: | Yutaka Shimada, MD, PhD | Toyama University Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00766480 History of Changes |
| Other Study ID Numbers: | CDR0000615602, TOYAMAU- TRIEC0601 |
| Study First Received: | October 3, 2008 |
| Last Updated: | January 7, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
squamous cell carcinoma of the esophagus stage II esophageal cancer stage III esophageal cancer |
Additional relevant MeSH terms:
|
Esophageal Neoplasms Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013