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Completed

NCT Number: NCT02605265

Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1

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.

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Key information

Conditions

Locally Advanced Rectal Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation

Radiation

Pelvic Radiation: 50Gy/25Fx

Capecitabine

Drug

Other names: Xeloda

Irinotecan

Drug

Other names: CPT-11

Oxaliplatin

Drug

Primary outcomes

  1. Pathologic Complete Response

    Time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation

Secondary outcomes

  1. Overall Survival

    Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years

  2. 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

  3. 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

  4. Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0

    Time frame: Up to 2 years

  5. Surgical complications

    Time frame: Surgery scheduled 6-8 weeks after the end of chemotherapy

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CinClare

Important dates

Study start
2015
Primary completion
2017
Study completion
2023
First posted
Nov 16, 2015
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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