Clinical trial NCT00420394: Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer
Official title: Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: Neoadjuvant chemotherapy
Adjuvant chemoradiotherapy
Adenocarcinoma of stomach and gastroesophageal junction
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the study regimen.
Secondary outcomes:
measure: Rate of R0 resection following chemotherapy.
measure: Morbidity and mortality of surgery following chemotherapy.
measure: Overall and progression free survival following the study treatment plan
Other outcomes:
Locations:
city: Beer-sheva
country: Israel
facility: Soroka University Medical Center,Oncology Center
Study officials:
affiliation: Soroka University Medical Center and Ben-Gurion University of the Negev
name: Margarita Tokar, MD
role: STUDY_CHAIR
References: