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Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

Primary Purpose

Advanced Rectal Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)
standard chemoradiotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Rectal Cancer focused on measuring Rectal cancer, neoadjuvant chemoradiotherapy, optimization

Eligibility Criteria

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

Inclusion Criteria:

  • Pathological confirmed rectal cancer
  • Clinical stage T3-4 or T any N1
  • No metastasis
  • Distance of tumor is no more than 10cm from anal verge
  • No previous radiotherapy
  • Age ranged from 18 to 70
  • Eastern Cooperative Oncology Group score system 0-1

Exclusion Criteria:

  • Clinical stage T1-2 N0
  • Distance metastasis
  • Multiple primary tumor
  • Cachexy

Sites / Locations

  • Sun Yat-Sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard chemoradiotherapy

induction and gap chemotherapy

Arm Description

Standard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy )

induction chemotherapy (Capecitabine 2000mg/m2 +oxaliplatine 130mg/m2) + 2 cycles of chemoradiotherapy (Capecitabine 2000mg/m2 +oxaliplatine 100mg/m2 combined with radiotherapy) + gap chemotherapy (Capecitabine 2000mg/m2 + oxaliplatine 130mg/m2)

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease free survival
Disease free survival
Respond rate

Full Information

First Posted
December 30, 2013
Last Updated
August 23, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02031939
Brief Title
Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer
Official Title
Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2014 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Rectal Cancer
Keywords
Rectal cancer, neoadjuvant chemoradiotherapy, optimization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
556 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard chemoradiotherapy
Arm Type
Active Comparator
Arm Description
Standard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy )
Arm Title
induction and gap chemotherapy
Arm Type
Experimental
Arm Description
induction chemotherapy (Capecitabine 2000mg/m2 +oxaliplatine 130mg/m2) + 2 cycles of chemoradiotherapy (Capecitabine 2000mg/m2 +oxaliplatine 100mg/m2 combined with radiotherapy) + gap chemotherapy (Capecitabine 2000mg/m2 + oxaliplatine 130mg/m2)
Intervention Type
Drug
Intervention Name(s)
Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)
Intervention Description
All rectal cancer patients in this group will receive induction, gap chemotherapy (capecitabine combined with oxaliplatin) alone with chemoradiotherapy (capecitabine combine with oxaliplatin) before surgery.
Intervention Type
Radiation
Intervention Name(s)
standard chemoradiotherapy
Intervention Description
All rectal patients in this group will receive standard radiotherapy and surgical resection.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
disease free survival
Time Frame
3 years
Title
Disease free survival
Time Frame
5 years
Title
Respond rate
Time Frame
One week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathological confirmed rectal cancer Clinical stage T3-4 or T any N1 No metastasis Distance of tumor is no more than 10cm from anal verge No previous radiotherapy Age ranged from 18 to 70 Eastern Cooperative Oncology Group score system 0-1 Exclusion Criteria: Clinical stage T1-2 N0 Distance metastasis Multiple primary tumor Cachexy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen-Hai Lu, Prof.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

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Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

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