Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma
|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: NCT01711242|
Recruitment Status : Unknown
Verified April 2016 by xie congying, Wenzhou Medical University.
Recruitment status was: Recruiting
First Posted : October 22, 2012
Last Update Posted : April 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: Capecitabine Drug: Oxaliplatin Radiation: Radiotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase III Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
sequence chemoradiotherapy following radical resection
sequence chemoradiotherapy two cycles of XELOX + concurrent chemoradiotherapy + two cycles of XELOX.
Postoperative radiotherapy regimen: Radiotherapy consisted of 4500 centigray of radiation at 180 centigray per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.
Concurrent chemotherapy regimen: capecitabine 825 mg/m² twice daily Postoperative chemotherapy regimen: see arm 2
Active Comparator: capecitabine/Oxaliplatin
chemotherapy alone following radical resection
Drug: chemotherapy alone following radical resection Postoperative chemotherapy regimen: The XELOX regimen was administrated: Oxaliplatin, 130mg/m2/day on day1, i.v. 2h; Capecitabine 1000mg/m²/day twice daily d1-14; every 21 days repeated, for 4 cycles.
- disease free survival [ Time Frame: 3-year ]
- 5 year Overall Survival [ Time Frame: 5 years ]
- Health-related quality of life [ Time Frame: five years after enrollment ]assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: during treatment ]assessed by NCI Common Terminology Criteria v3.0
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): NCT01711242
|The First Affiliated Hospital of Wenzhou Medical College||Recruiting|
|Wenzhou, Zhejiang, China, 325000|
|Contact: congying xie, MD 86-0577-8806-9316 firstname.lastname@example.org|
|Principal Investigator:||congying xie, MD||First Affiliated Hospital of Wenzhou Medical University|
|Principal Investigator:||xiaolei chen, MD||First Affiliated Hospital of Wenzhou Medical University|