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

April 28, 2022 updated by: Ziqiang Wang,MD, West China Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Guoxue Road 37#,West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chemotherapy group
patients receive 4 cycles of Xelox
Drug: XELOX
Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor volume
Time Frame: At the end of Cycle 2 (each cycle is 3 weeks)
tumor volume measured by MRI
At the end of Cycle 2 (each cycle is 3 weeks)
tumor area in endoscopy
Time Frame: At the end of Cycle 2 (each cycle is 3 weeks)
tumor area measured in endoscopy
At the end of Cycle 2 (each cycle is 3 weeks)
tumor volume
Time Frame: At the end of Cycle 4 (each cycle is 3 weeks)
tumor volume measured by MRI
At the end of Cycle 4 (each cycle is 3 weeks)
tumor area in endoscopy
Time Frame: At the end of Cycle 4 (each cycle is 3 weeks)
tumor area measured in endoscopy
At the end of Cycle 4 (each cycle is 3 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood DNA test
Time Frame: At the end of Cycle 2 (each cycle is 3 weeks)
blood DNA test
At the end of Cycle 2 (each cycle is 3 weeks)
blood DNA test
Time Frame: At the end of Cycle 4 (each cycle is 3 weeks)
blood DNA test
At the end of Cycle 4 (each cycle is 3 weeks)
tumor thickness in TRUS
Time Frame: At the end of Cycle 4 (each cycle is 3 weeks)
tumor thickness in TRUS
At the end of Cycle 4 (each cycle is 3 weeks)
tumor thickness in TRUS
Time Frame: At the end of Cycle 2 (each cycle is 3 weeks)
tumor thickness in TRUS
At the end of Cycle 2 (each cycle is 3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Study Chair: Ziqiang Wang, MD, West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

August 18, 2018

First Submitted That Met QC Criteria

September 9, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-CT-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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