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Locally Advanced Rectal CancerPhase 3CinClareNCT02605265

Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1

A Phase 3 study testing Radiation, Capecitabine and Irinotecan in people with Locally Advanced Rectal Cancer, run by Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Locally Advanced Rectal Cancer
What is being tested?
Radiation, Capecitabine and Irinotecan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
356 participants
Where
1 siteChina
Study dates
Oct 2015to Jun 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: 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.

Keywords
Neoadjuvant Chemoradiation, Irinotecan, UGT1A1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02605265
Study groupRoleWhat they receive
Capecitabine AloneActive comparatorConcurrent 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
Receives: Radiation: Radiation; Drug: Capecitabine; Drug: Oxaliplatin
Capecitabine with IrinotecanExperimentalConcurrent 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
Receives: Radiation: Radiation; Drug: Capecitabine; Drug: Irinotecan; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Complete Response

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

Secondary outcomes (5)

  1. Overall Survival

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

  2. Disease-free Survival

    Measured: 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

    Number of participants with pelvic failure after surgery, evaluated using Kaplan-Meier Curve

    Measured: From date of randomization until the date of first documented pelvic failure, assessed up to 10 years

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

    Measured: Up to 2 years

  5. Surgical complications

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2017
  4. Study completionJun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02605265
Sponsor's protocol ID
FDRT-R005
Acronym
CinClare
Status last verified
Aug 2025
First submitted
9 Nov 2015
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhang Z, Sun X, Liu A, Zhu Y, Zhang T, Liu L, Jia J, Tan S, Wu J, Wang X, Zhou J, Yang J, Zhang C, Zhang H, He X, Cai G, Huang C, Xia F, Wan J, Zhang H, Shen L, Wang L, Zhang W, Cai S, Zhu J. Neoadjuvant chemoradiotherapy with capecitabine and irinotecan guided by UGT1A1 status in patients with locally advanced rectal cancer: 5-year update of the CinClare trial. Cancer Commun (Lond). 2025 Nov;45(11):1417-1430. doi: 10.1002/cac2.70058. Epub 2025 Sep 3.

    PubMed 40899645

  • Zhang X, Fan J, Zhang L, Wang J, Wang M, Zhu J. Association Between Three-Dimensional Transrectal Ultrasound Findings and Tumor Response to Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer: An Observational Study. Front Oncol. 2021 Jun 4;11:648839. doi: 10.3389/fonc.2021.648839. eCollection 2021.

    PubMed 34178635

  • Zhu J, Liu A, Sun X, Liu L, Zhu Y, Zhang T, Jia J, Tan S, Wu J, Wang X, Zhou J, Yang J, Zhang C, Zhang H, Zhao Y, Cai G, Zhang W, Xia F, Wan J, Zhang H, Shen L, Cai S, Zhang Z. Multicenter, Randomized, Phase III Trial of Neoadjuvant Chemoradiation With Capecitabine and Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer. J Clin Oncol. 2020 Dec 20;38(36):4231-4239. doi: 10.1200/JCO.20.01932. Epub 2020 Oct 29.

    PubMed 33119477

  • Yao Y, Xu X, Yang L, Zhu J, Wan J, Shen L, Xia F, Fu G, Deng Y, Pan M, Guo Q, Gao X, Li Y, Rao X, Zhou Y, Liang L, Wang Y, Zhang J, Zhang H, Li G, Zhang L, Peng J, Cai S, Hu C, Gao J, Clevers H, Zhang Z, Hua G. Patient-Derived Organoids Predict Chemoradiation Responses of Locally Advanced Rectal Cancer. Cell Stem Cell. 2020 Jan 2;26(1):17-26.e6. doi: 10.1016/j.stem.2019.10.010. Epub 2019 Nov 21.

    PubMed 31761724

  • Guan Y, Shen Y, Xu Y, Li C, Wang J, Gu W, Lian P, Huang D, Cai S, Zhang Z, Zhu J. An expansion study of genotype-driven weekly irinotecan and capecitabine in combination with neoadjuvant radiotherapy for locally advanced rectal cancer with UGT1A1 *1*1 genotype. Ther Adv Gastroenterol. 2019 Jun 6;12:1756284819852293. doi: 10.1177/1756284819852293. eCollection 2019.

    PubMed 31217818

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiation, Capecitabine and Irinotecan in people with Locally Advanced Rectal Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response (time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02605265, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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