NCT02291744

A Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients

A Randomized Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients With Unresectable Metastatic Lesions

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary endpoint is to evaluate the TFS (time to failure of strategy).

Detailed description

The primary endpoint is to evaluate the time to failure of strategy, that is the second progression time after induction therapy by the use of XELOX regimen, comparing XELOX regimen chemotherapy combined with or without surgical resection of the primary lesion from the time of randomization to maintenance therapy and reapplication of induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment.

Conditions

• Metastatic Colon Cancer

Interventions

Type	Name	Description
PROCEDURE	resection of primary lesion	Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle, and resection of primary lesion with metastatic colon cancer
DRUG	XELOX	Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle,

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2014-11-14
• Last updated: 2015-11-11

Locations

1 site across 1 country: China