NCT01584544

Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.

Detailed description

It is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage II/III rectal cancer patients. But elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility. Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out. The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.

Conditions

• Rectal Neoplasms

Interventions

Type	Name	Description
DRUG	capecitabine	oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
DRUG	Capecitabine	oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
DRUG	Capecitabine	oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
DRUG	Capecitabine	oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
DRUG	Capecitabine	oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-04-25
• Last updated: 2015-04-20
• Results posted: 2015-04-20

Locations

1 site across 1 country: China