Stomach Neoplasms
Conditions
Keywords
Neoadjuvant chemotherapy, Adjuvant chemoradiotherapy, Adenocarcinoma of stomach and gastroesophageal junction
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
Interventions
PROCEDUREChemotherapy
PROCEDUREsurgery
PROCEDUREradiotherapy
Sponsors
Soroka University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the study regimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of R0 resection following chemotherapy. | — |
| Morbidity and mortality of surgery following chemotherapy. | — |
| Overall and progression free survival following the study treatment plan | — |
Countries
Israel
Contacts
Primary ContactMargarita Tokar, MD
Backup ContactDmitri Bobilev, MD
Outcome results
None listed