Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 (CinClare)

August 21, 2025 updated by: Zhen Zhang, Fudan University

A Randomized Phase III Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer

The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of participants will receive capecitabine alone together with neoadjuvant CRT, followed by a cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 3

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
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center

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

Description

Inclusion Criteria:

  • pathological confirmed adenocarcinoma
  • clinical stage T3-4 and/or N+
  • the distance from anal verge less than 12 cm
  • without distance metastases
  • KPS >=70
  • UGT1A1*28 6/6 or 6/7
  • without previous anti-cancer therapy
  • sign the inform consent

Exclusion Criteria:

  • pregnancy or breast-feeding women
  • serious medical illness
  • 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
  • DPD deficiency
  • UGT1A1*28 7/7

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
Active Comparator: Capecitabine Alone

Concurrent Chemoradiotherapy:

Radiation: 50Gy/25Fx; Capecitabine: 825mg/m2 bid Monday-Friday per week

Chemotherapy in Interval Between CRT and Surgery:

Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1

Surgery:

Scheduled 6-8 weeks after the completion of CRT

Adjuvant Chemotherapy:

Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles
Drug: Oxaliplatin
Drug: Capecitabine
Other Names:
  • Xeloda
Radiation: Radiation
Pelvic Radiation: 50Gy/25Fx
Experimental: Capecitabine with Irinotecan

Concurrent Chemoradiotherapy:

Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)

Chemotherapy in Interval Between CRT and Surgery:

Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1

Surgery:

Scheduled 6-8 weeks after the completion of CRT

Adjuvant Chemotherapy:

Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles
Drug: Oxaliplatin
Drug: Capecitabine
Other Names:
  • Xeloda
Drug: Irinotecan
Other Names:
  • CPT-11
Radiation: Radiation
Pelvic Radiation: 50Gy/25Fx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic Complete Response
Time Frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
Surgery scheduled 6-8 weeks after the end of chemoradiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 10 years
From date of randomization until the date of death from any cause, assessed up to 10 years
Disease-free Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years
Local Control rate
Time Frame: From date of randomization until the date of first documented pelvic failure, assessed up to 10 years
Number of participants with pelvic failure after surgery, evaluated using Kaplan-Meier Curve
From date of randomization until the date of first documented pelvic failure, assessed up to 10 years
Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0
Time Frame: Up to 2 years
Up to 2 years
Surgical complications
Time Frame: Surgery scheduled 6-8 weeks after the end of chemotherapy
Surgery scheduled 6-8 weeks after the end of chemotherapy

Collaborators and Investigators

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

Sponsor

Fudan University

Collaborators

The First Affiliated Hospital with Nanjing Medical University
Hubei Cancer Hospital
Ruijin Hospital
First Affiliated Hospital of Chongqing Medical University

Investigators

  • Principal Investigator: Zhen Zhang, MD, Fudan University

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

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)

October 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 13, 2015

First Posted (Estimated)

November 16, 2015

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-R005

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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