Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer

Phase 2

• Conditions: Stomach Neoplasms

• Registration Number: NCT00420394
• Lead Sponsor: Soroka University Medical Center

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 gastric cancer results in significant tumoral downstaging with improved rate of curative resections.

Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and postoperative chemoradiation for locally advanced adenocarcinoma of stomach and gastroesophageal cancer

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-01
• Study First Submitted: 2007-01-09
• Study First Submitted QC: 2007-01-09
• Study First Posted: 2007-01-11
• Study Start: 2007-04
• Last Update Submitted: 2007-06-19
• Last Update Posted: 2007-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
2. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
3. Disease must be clinically limited to the stomach or GEJ.
4. Pre-treatment Port-a-Cath insertion obligatory
5. No prior chemotherapy.
6. No prior radiotherapy.
7. Patients must be surgical candidates as determined by the treating surgeon.
8. Adequate organ function defined as:
9. Patients must have an ECOG Performance Status < 1.
10. Patients must be able to sign the informed consent document.

Exclusion Criteria

1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
2. Patients with primary carcinomas of the esophagus.
3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
4. Patients with evidence of metastatic disease are not eligible.
5. New York Heart Association Class III or IV heart disease.
6. Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized by complications of the study treatment.
7. Pregnant or lactating women or men unable or unwilling to practice contraception are excluded.
8. Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer).
9. Clinically significant hearing loss.
10. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
11. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
12. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the study regimen.

Secondary Outcome Measures

Name	Time	Method
Rate of R0 resection following chemotherapy.
Morbidity and mortality of surgery following chemotherapy.
Overall and progression free survival following the study treatment plan

Trial Locations

Locations (1)

Soroka University Medical Center,Oncology Center; 🇮🇱 Beer-sheva, Israel