Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1

Locally Advanced Rectal Cancer Clinical Trial

— CinClare  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02605265
• Other study ID #: FDRT-R005
• Status: Recruiting
• Phase: Phase 3
• First received: November 9, 2015
• Last updated: December 5, 2016
• Start date: October 2015
• Est. completion date: December 2020

Study information

• Verified date: December 2016
• Source: Fudan University
• Contact: Ji Zhu, MD
• Phone: +86-2164175590
• Email: leo.zhu[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Radiation
Pelvic Radiation: 50Gy/25Fx

Drug:
• Capecitabine

• Irinotecan

• Oxaliplatin

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Fudan University	First Affiliated Hospital of Chongqing Medical University, Hubei Cancer Hospital, Ruijin Hospital, The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response		Surgery scheduled 6-8 weeks after the end of chemoradiation	No
Secondary	Overall Survival		From date of randomization until the date of death from any cause, assessed up to 10 years	No
Secondary	Disease-free Survival		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	No
Secondary	Local Control rate	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	No
Secondary	Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0		Up to 2 years	Yes
Secondary	Surgical complications		Surgery scheduled 6-8 weeks after the end of chemotherapy	Yes