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

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
XELOX
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer;, neoadjuvant Chemotherapy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Guoxue Road 37#,West China Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemotherapy group

Arm Description

patients receive 4 cycles of Xelox

Outcomes

Primary Outcome Measures

tumor volume
tumor volume measured by MRI
tumor area in endoscopy
tumor area measured in endoscopy
tumor volume
tumor volume measured by MRI
tumor area in endoscopy
tumor area measured in endoscopy

Secondary Outcome Measures

blood DNA test
blood DNA test
blood DNA test
blood DNA test
tumor thickness in TRUS
tumor thickness in TRUS
tumor thickness in TRUS
tumor thickness in TRUS

Full Information

First Posted
August 18, 2018
Last Updated
April 28, 2022
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03666442
Brief Title
Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer
Official Title
Early Evaluation of Chemosensitivity for Low-risk Stage II/III Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer;, neoadjuvant Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
a group of patients receive 4 cycle of Xelox chemotherapy, MRI,TRUS, DE,endoscopy, blood DNA test,before, between and after chemotherapy was compared to detect the effect of chemotherapy in 2 cycles.
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chemotherapy group
Arm Type
Experimental
Arm Description
patients receive 4 cycles of Xelox
Intervention Type
Drug
Intervention Name(s)
XELOX
Intervention Description
Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks
Primary Outcome Measure Information:
Title
tumor volume
Description
tumor volume measured by MRI
Time Frame
At the end of Cycle 2 (each cycle is 3 weeks)
Title
tumor area in endoscopy
Description
tumor area measured in endoscopy
Time Frame
At the end of Cycle 2 (each cycle is 3 weeks)
Title
tumor volume
Description
tumor volume measured by MRI
Time Frame
At the end of Cycle 4 (each cycle is 3 weeks)
Title
tumor area in endoscopy
Description
tumor area measured in endoscopy
Time Frame
At the end of Cycle 4 (each cycle is 3 weeks)
Secondary Outcome Measure Information:
Title
blood DNA test
Description
blood DNA test
Time Frame
At the end of Cycle 2 (each cycle is 3 weeks)
Title
blood DNA test
Description
blood DNA test
Time Frame
At the end of Cycle 4 (each cycle is 3 weeks)
Title
tumor thickness in TRUS
Description
tumor thickness in TRUS
Time Frame
At the end of Cycle 4 (each cycle is 3 weeks)
Title
tumor thickness in TRUS
Description
tumor thickness in TRUS
Time Frame
At the end of Cycle 2 (each cycle is 3 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziqiang Wang, MD
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Guoxue Road 37#,West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24419115
Citation
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Results Reference
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Citation
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Citation
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Citation
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Citation
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Citation
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25822672
Citation
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Citation
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Results Reference
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Links:
URL
https://www.nccn.org/professionals/physician_gls/pdf/rectal.pdf
Description
NCCN guideline

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

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