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

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ClinicalTrials.gov Identifier: NCT02605265
Recruitment Status : Recruiting
First Posted : November 16, 2015
Last Update Posted : December 7, 2016
Sponsor:
Collaborators:
The First Affiliated Hospital with Nanjing Medical University
Hubei Cancer Hospital
First Affiliated Hospital of Chongqing Medical University
Ruijin Hospital
Information provided by (Responsible Party):
Zhen Zhang, Fudan University

Brief 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. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.

Condition or disease Intervention/treatment Phase
Locally Advanced Rectal Cancer Radiation: Radiation Drug: Capecitabine Drug: Irinotecan Drug: Oxaliplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1 in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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

Radiation: Radiation
Pelvic Radiation: 50Gy/25Fx

Drug: Capecitabine
Other Name: Xeloda

Drug: Oxaliplatin
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

Radiation: Radiation
Pelvic Radiation: 50Gy/25Fx

Drug: Capecitabine
Other Name: Xeloda

Drug: Irinotecan
Other Name: CPT-11

Drug: Oxaliplatin



Primary Outcome Measures :
  1. Pathologic Complete Response [ Time Frame: Surgery scheduled 6-8 weeks after the end of chemoradiation ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605265


Contacts
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Contact: Ji Zhu, MD +86-2164175590 ext 81607 leo.zhu@126.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ji Zhu, MD       leo.zhu@126.com   
Principal Investigator: Zhen Zhang, MD         
Sub-Investigator: Ji Zhu, MD         
Sponsors and Collaborators
Fudan University
The First Affiliated Hospital with Nanjing Medical University
Hubei Cancer Hospital
First Affiliated Hospital of Chongqing Medical University
Ruijin Hospital
Investigators
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Principal Investigator: Zhen Zhang, MD Fudan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhen Zhang, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02605265    
Other Study ID Numbers: FDRT-R005
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Keywords provided by Zhen Zhang, Fudan University:
Neoadjuvant Chemoradiation
Irinotecan
UGT1A1
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors