NCT01674959

Postoperative IMRT Combined With Capecitabine for Advanced Gastric Cancer Patients

Phase II Study of Postoperative Intensity-modulated Radiotherapy (IMRT) Combined With Capecitabine for Stage II/III Gastric Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Radiation therapy plus concurrent chemotherapy has been demonstrated a significant improvement in overall and disease-free survival according to Intergroup Trial 0116 in patients with gastric cancer after surgical complete resection. Advantage of application of IMRT has been shown in planning comparison studies for postoperative gastric patients. So the investigators designed the trial to see safety and efficacy of postoperative concurrent chemoradiotherapy of capecitabine combined with IMRT for stage II/II gastric cancer.

Detailed description

In Intergroup 0116, only 64% patients in concurrent chemoradiation group completed treatment as planed, but in recently reported ARTIST trial, capecitabine was admitted to concurrent with radiotherapy,patients who completed treatment as planed in concurrent group reach high as 80%. IMRT is an advanced radiotherapy technology which allows high conformal dose distribution to Planing Tumor Volume (PTV) and low dose to organ at risk. The purpose of this study is to evaluate feasibility and efficacy of concurrent IMRT combined with capecitabine for the treatment of gastric cancer patients after D1/2 surgery.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
RADIATION	concurrent chemoradiation	postoperative Intensity-modulated radiotherapy (IMRT) combined with capecitabine for high risk gastric cancer patients Radiation: concurrent chemoradiotherapy Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 6MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy 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. Postoperative chemotherapy regimen: capecitabine( 1,600 mg/m2 per day for 5 weeks).

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-12-01
• Completion: 2017-12-01
• First posted: 2012-08-29
• Last updated: 2015-02-05

Locations

1 site across 1 country: China