Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00718913|
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : May 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: Docetaxel Drug: Cisplatin Drug: Capecitabine Radiation: Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
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: Taxotere
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: CDDP
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: Xeloda
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: RT
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
- 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 ]
- Toxicity profile [ Time Frame: Toxicity assessment on each cycle ]
- Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ]
- Overall survival [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|