Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer (TORCH-E2)

June 12, 2024 updated by: Zhen Zhang, Fudan University

A Prospective, Randomized, Phase II Trial of Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer

TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response [pCR] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

134

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 Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age 18-75 years old, female and male
  2. pathological confirmed adenocarcinoma
  3. clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm
  4. the distance from anal verge less than 5 cm
  5. without distance metastases
  6. KPS >=70
  7. with good compliance
  8. microsatellite repair status is MSS/pMMR
  9. without previous anti-cancer therapy or immunotherapy
  10. signed the inform consent

Exclusion Criteria:

  1. pregnancy or breast-feeding women
  2. pathological confirmed signet ring cell carcinoma
  3. clinical stage T1N0 and can be resected locally
  4. history of other malignancies within 5 years
  5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
  6. immunodeficiency disease or long-term using of immunosuppressive agents
  7. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
  8. DPD deficiency
  9. allergic to any component of the therapy

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short-course Radiotherapy plus immunochemotherapy group
The patients will receive short-course radiotherapy (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option.
Drug: Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Radiation: Short-course radiotherapy
Short-course radiotherapy: 25Gy/5Fx
Other Names:
  • SCRT
Drug: PD-1 antibody (Toripalimab)
Toripalimab 240mg d1 q3w
Other Names:
  • Toripalimab
Drug: Capecitabine
Xeloda
Other Names:
  • Xeloda
Experimental: Long-course Radiotherapy plus chemotherapy group
The patients will receive long-course radiotherapy (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option.
Drug: Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Drug: Capecitabine
Xeloda
Other Names:
  • Xeloda
Radiation: Long-course radiotherapy
Long-course radiation: 50Gy/25Fx
Other Names:
  • LCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete response (CR) rate
Time Frame: 1 month after the surgery or the decision of W&W
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy.
1 month after the surgery or the decision of W&W

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 year disease free survival rate
Time Frame: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Rate of 3 year disease free survival
From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3 year local recurrence free survival rate
Time Frame: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
Rate of 3 year local recurrence free survival
From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
3 year overall survival rate
Time Frame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
Rate of 3 year overall survival
From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
Grade 3-4 adverse effects rate
Time Frame: From date of randomization until 3 months after the completion neoadjuvant therapy
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
From date of randomization until 3 months after the completion neoadjuvant therapy
Organ preservation rate
Time Frame: from date of receiving neoadjuvant therapy, assessed up to 3 years
Organ preservation rate
from date of receiving neoadjuvant therapy, assessed up to 3 years
3 year Quality of Life
Time Frame: From date of initiation of treatment until the date of death from any cause, assessed up to 3 years
Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score.
From date of initiation of treatment until the date of death from any cause, assessed up to 3 years

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhen Zhang, M.D, PH.D, Fudan University

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)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-2023-377-3496

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.

Clinical Trials on Early Low Rectal Cancer

Clinical Trials on Oxaliplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe