Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer

Phase 2

Completed

• Conditions: Rectal Cancer
• Interventions: Drug: XELOX

• Registration Number: NCT03666442
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-08-18
• Study First Submitted QC: 2018-09-09
• Study First Posted: 2018-09-11
• Primary Completion: 2020-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. .endoscopy and biopsy verified rectal cancer within 12cm from anal verge;
2. .primary MRI, TRUS, abdomino-chest CT diagnosed early or intermediate or bad Stage II/III rectal cancer;
3. .age from 20-75;
4. .with informed consent;

Exclusion Criteria

1. .refuse the further treatment after recruiting;
2. .diagnosis of peritoneal metastasis in the surgery;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemotherapy group	XELOX	patients receive 4 cycles of Xelox

Primary Outcome Measures

Name	Time	Method
tumor volume	At the end of Cycle 4 (each cycle is 3 weeks)	tumor volume measured by MRI
tumor area in endoscopy	At the end of Cycle 4 (each cycle is 3 weeks)	tumor area measured in endoscopy

Secondary Outcome Measures

Name	Time	Method
tumor thickness in TRUS	At the end of Cycle 2 (each cycle is 3 weeks)	tumor thickness in TRUS
blood DNA test	At the end of Cycle 4 (each cycle is 3 weeks)	blood DNA test

Trial Locations

Locations (1)

Guoxue Road 37#,West China Hospital; 🇨🇳 Chengdu, Sichuan, China