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

Primary Purpose

Locally Advanced Rectal Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Radiation

Capecitabine

Irinotecan

Oxaliplatin

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Cancer focused on measuring Neoadjuvant Chemoradiation, Irinotecan, UGT1A1

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Capecitabine Alone

Capecitabine with Irinotecan

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pathologic Complete Response

Secondary Outcome Measures

Overall Survival

Disease-free Survival

Local Control rate

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

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

Surgical complications

Full Information

NCT ID

NCT02605265

First Posted

November 9, 2015

Last Updated

December 5, 2016

Sponsor

Fudan University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02605265

Brief Title

Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Rectal Cancer

Keywords

Neoadjuvant Chemoradiation, Irinotecan, UGT1A1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine Alone

Arm Type

Active Comparator

Arm Description

Arm Title

Capecitabine with Irinotecan

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

Pelvic Radiation: 50Gy/25Fx

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Other Intervention Name(s)

CPT-11

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Primary Outcome Measure Information:

Title

Pathologic Complete Response

Time Frame

Surgery scheduled 6-8 weeks after the end of chemoradiation

Secondary Outcome Measure Information:

Title

Overall Survival

Time Frame

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

Title

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

Title

Local Control rate

Description

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

Time Frame

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

Title

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

Time Frame

Up to 2 years

Title

Surgical complications

Time Frame

Surgery scheduled 6-8 weeks after the end of chemotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ji Zhu, MD

Phone

+86-2164175590

Ext

81607

leo.zhu@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhen Zhang, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ji Zhu, MD

leo.zhu@126.com

First Name & Middle Initial & Last Name & Degree

Zhen Zhang, MD

First Name & Middle Initial & Last Name & Degree

Ji Zhu, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34178635

Citation

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.

Results Reference

derived

PubMed Identifier

33119477

Citation

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.

Results Reference

derived

PubMed Identifier

31761724

Citation

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.

Results Reference

derived

PubMed Identifier

31217818

Citation

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.

Results Reference

derived

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Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1

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