Status:
UNKNOWN
Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer
Lead Sponsor:
Soroka University Medical Center
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in locally advanced...
Eligibility Criteria
Inclusion
- Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
- T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
- Disease must be clinically limited to the stomach or GEJ.
- Pre-treatment Port-a-Cath insertion obligatory
- No prior chemotherapy.
- No prior radiotherapy.
- Patients must be surgical candidates as determined by the treating surgeon.
- Adequate organ function defined as:
- Patients must have an ECOG Performance Status \< 1.
- Patients must be able to sign the informed consent document.
Exclusion
- Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
- Patients with primary carcinomas of the esophagus.
- Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
- Patients with evidence of metastatic disease are not eligible.
- New York Heart Association Class III or IV heart disease.
- Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized by complications of the study treatment.
- Pregnant or lactating women or men unable or unwilling to practice contraception are excluded.
- Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer).
- Clinically significant hearing loss.
- Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
- Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
- Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00420394
Start Date
April 1 2007
Last Update
June 20 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Soroka University Medical Center,Oncology Center
Beersheba, Israel