A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

June 6, 2021 updated by: Jing Jin, M.D.
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.

Study Type

Interventional

Enrollment (Anticipated)

150

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 Contact

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
        • Contact:

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Rectal adenocarcinoma confirmed by histopathology
  2. MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)
  3. The age is 18-75 years old, no gender limit

3) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1

Exclusion Criteria:

  1. History of other malignant tumors;
  2. They were allergic to 5-FU, platinum, etc;
  3. The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;
  4. After the previous renal history, proteinuria or clinical renal function were found to be abnormal;
  5. History of gastrointestinal fistula, perforation or severe ulcer;
  6. At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group CRT
concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
Procedure: TME
Total mesorectal excision
Combination product: Concurrent Chemoradiotherapy Radiotherapy
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.
Other Names:
  • CRT
Drug: Adjuvant chemotherapy
2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles. 6 courses*3 weeks per course
Other Names:
  • XEOLX*6 courses
Experimental: Group SCRT
Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Procedure: TME
Total mesorectal excision
Radiation: Short-course Radiotherapy
25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Other Names:
  • SCRT
Drug: Consolidation chemotherapy
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses*3 weeks per course.
Other Names:
  • XEOLX*4 courses
Experimental: Group es-SCRT
Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Procedure: TME
Total mesorectal excision
Drug: Consolidation chemotherapy
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses*3 weeks per course.
Other Names:
  • XEOLX*4 courses
Radiation: Local dose increase of Short-course Radiotherapy
25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Other Names:
  • es-SCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: 1 year
R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3y OS
Time Frame: 3 years
3-year overall survival
3 years
3yDMFS
Time Frame: 3 years
3-year distant metastatic free survival
3 years
3yLRRFS
Time Frame: 3 years
3-year locoregional recurrence-free survival
3 years

Collaborators and Investigators

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

Sponsor

Jing Jin, M.D.

Investigators

  • Study Director: Yuan Tang, M.D., Chinese Academy of Medical Sciences and Peking Union Medical College

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)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

December 6, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 6, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3332019055

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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