Early Evaluation of Chemosensitivity for Low-risk Stage II/III Rectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- XELOX
- Conditions
- Rectal Cancer
- Sponsor
- West China Hospital
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- tumor volume
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.
Detailed Description
Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.In future, a phase III trial that explore the effect of radiation or surgery in these chemoresistant patients.
Investigators
Ziqiang Wang,MD
professor
West China Hospital
Eligibility Criteria
Inclusion Criteria
- •.endoscopy and biopsy verified rectal cancer within 12cm from anal verge;
- •.primary MRI, TRUS, abdomino-chest CT diagnosed early or intermediate or bad Stage II/III rectal cancer;
- •.age from 20-75;
- •.with informed consent;
Exclusion Criteria
- •.refuse the further treatment after recruiting;
- •.diagnosis of peritoneal metastasis in the surgery;
Arms & Interventions
chemotherapy group
patients receive 4 cycles of Xelox
Intervention: XELOX
Outcomes
Primary Outcomes
tumor volume
Time Frame: At the end of Cycle 4 (each cycle is 3 weeks)
tumor volume measured by MRI
tumor area in endoscopy
Time Frame: At the end of Cycle 4 (each cycle is 3 weeks)
tumor area measured in endoscopy
Secondary Outcomes
- tumor thickness in TRUS(At the end of Cycle 2 (each cycle is 3 weeks))
- blood DNA test(At the end of Cycle 4 (each cycle is 3 weeks))