NCT03142282

Consolidative Radiotherapy Plus Maintenance Chemotherapy for Metastatic Colorectal Cancer

Maintenance Chemotherapy Versus Consolidative Radiotherapy Plus Maintenance Chemotherapy for Unresectable Metastatic Colorectal Cancer: A Randomized Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a randomized phase II trial of maintenance chemotherapy versus consolidative radiotherapy plus maintenance chemotherapy for patients with unresectable metastatic colorectal cancer (MCRC).

Detailed description

Prior to accrual on the trial, patients with unresectable metastatic colorectal cancer will be treated with palliative chemotherapy. And patients who achieve a partial response or stable disease by imaging criteria will receive maintenance chemotherapy. In our study, these group patients will be randomized to maintenance chemotherapy or consolidative radiotherapy to all sites of disease (followed by maintenance chemotherapy at the medical oncologist's discretion). Choices of palliative and maintenance chemotherapy will be determined by the medical oncologist based on clinical appropriateness.

Conditions

• Metastatic Colorectal Cancer
• Radiotherapy

Interventions

Type	Name	Description
DRUG	maintenance chemotherapy	National Comprehensive Cancer Network (NCCN) or European Society for Medical Oncology (ESMO) suggested maintenance chemotherapy regimens: xeloda, bevacizumab
RADIATION	Consolidative Radiotherapy	Stereotacticbodyradiationtherapy (SBRT) or intensity modulated radiation therapy (IMRT) for metastatic sites (less than 5)

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-08-31
• Completion: 2024-08-31
• First posted: 2017-05-05
• Last updated: 2018-09-07

Locations

1 site across 1 country: China