Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer
This study will determine the feasibility of adjuvant chemotherapy and chemo-radiotherapy for patients with surgically resected adenocarcinoma of the stomach and gastro-esophageal junction.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction|
- The proportion of patients completing protocol therapy (feasibility) [ Time Frame: The feasibility will be defined as the proportion of patients who receive adjuvant chemotherapy and chemo-radiation over total registered ] [ Designated as safety issue: No ]
- Toxicity profile [ Time Frame: Toxicity assessment on each cycle ] [ Designated as safety issue: Yes ]
- Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
TCX ->RT -> TCX
Docetaxel will be given at 60 mg/m2, as a 60-minute infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Docetaxel 60 mg/m2.
Other Name: TaxotereDrug: Cisplatin
Cisplatin will be given at 60 mg/m2, as 2-hour infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Cisplatin at 60 mg/m2.
Other Name: CDDPDrug: Capecitabine
Capecitabine will be given orally at 1800 mg/m2 days 1 through 14 divided in two daily doses before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Capecitabine at 1800 mg/m2 days 1 through 14 (divided in two daily doses).
Other Name: XelodaRadiation: Radiation
At the end of the second cycle of chemotherapy and one week of rest (day 27), a total of 45 Gy (1.8 Gy fx/d) of radiotherapy will be given.
Other Name: RTDrug: Capecitabine
Capecitabine will be administered orally during radiotherapy for radiosensitization(1650 mg/m2 per day divided in two daily doses, 5 days/week, on Monday through Friday).
Other Name: Xeloda
Patients with localized gastric cancer often relapse either locally or systemically. A strategy to reduce relapses at common sites would be beneficial. Our prior trial has proved the feasibility of administering FOLFIRI regimen as adjuvant chemotherapy combined with adjuvant chemoradiation in patients with excised with curative intend gastric cancer. It would be important to improve the treatment involving active regimen as adjuvant chemotherapy and optimizing chemoradiation by introducing capecitabine as a radiosensitizer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718913
|University Hospital of Crete Dept of Medical Oncology|
|Heraklion, Crete, Greece|
|University General Hospital of Alexandroupolis, Dep of Medical Oncology|
|"IASO" General Hospital of Athens, 1st Dep of Medical Oncology|
|"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine|
|401 Military Hospital of Athens|
|Air Forces Military Hospital of Athens|
|General Hospital of Larissa Dept of Medical Oncology|
|"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology|
|Principal Investigator:||Ioannis Boukovinas, MD||"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology|