Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1
NCT ID: NCT02605265
Last Updated: 2025-08-28
Study Results
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Basic Information
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COMPLETED
PHASE3
356 participants
INTERVENTIONAL
2015-10-31
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Radiation
Pelvic Radiation: 50Gy/25Fx
Capecitabine
Oxaliplatin
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
Radiation
Pelvic Radiation: 50Gy/25Fx
Capecitabine
Irinotecan
Oxaliplatin
Interventions
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Radiation
Pelvic Radiation: 50Gy/25Fx
Capecitabine
Irinotecan
Oxaliplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Hubei Cancer Hospital
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Ruijin Hospital
OTHER
Fudan University
OTHER
Responsible Party
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Zhen Zhang
Professor
Principal Investigators
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Zhen Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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References
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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 Sep 3. doi: 10.1002/cac2.70058. Online ahead of print.
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.
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.
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.
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. Therap Adv Gastroenterol. 2019 Jun 6;12:1756284819852293. doi: 10.1177/1756284819852293. eCollection 2019.
Other Identifiers
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FDRT-R005
Identifier Type: -
Identifier Source: org_study_id
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