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Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

Primary Purpose

Locally Advanced Rectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Radiation

Capecitabine

Irinotecan

Amifostine

About this trial

This is an interventional prevention trial for Locally Advanced Rectal Cancer focused on measuring Neoadjuvant Chemoradiotherapy, amifostine, irinotecan, capecitabine

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
performance status score: 0~1
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 and Irinotecan without Amifostine

Capecitabine and Irinotecan with Amifostine

Arm Description

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: depends on patients pathological review.

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) Amifostine: 400mg/m2 per week 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: depends on patients pathological review.

Outcomes

Primary Outcome Measures

the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0

Secondary Outcome Measures

Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire and EORTC-QLQ-C30 questionnaire

pathological response rate

the morbidity of late radiation proctitis

Full Information

NCT ID

NCT03702985

First Posted

June 14, 2018

Last Updated

January 19, 2019

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03702985

Brief Title

Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

Official Title

A Phase II Trial of Capecitabine and Irinotecan With or Without Amifostine in Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 28, 2018 (Actual)

Primary Completion Date

November 1, 2019 (Anticipated)

Study Completion Date

March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine 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 it will depends which regimens the patient would receive according to his or her pathological results.

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 Chemoradiotherapy, amifostine, irinotecan, capecitabine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine and Irinotecan without Amifostine

Arm Type

Active Comparator

Arm Description

Arm Title

Capecitabine and Irinotecan with Amifostine

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 Description

625mg/m2 bid Monday-Friday per week

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)

Intervention Type

Drug

Intervention Name(s)

Amifostine

Intervention Description

400mg/m2 per week

Primary Outcome Measure Information:

Title

the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0

Time Frame

during neoadjuvant chemoradiation.

Secondary Outcome Measure Information:

Title

Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire and EORTC-QLQ-C30 questionnaire

Time Frame

during neoadjuvant chemoradiation.

Title

pathological response rate

Time Frame

Surgery scheduled 6-8 weeks after the end of chemoradiation.

Title

the morbidity of late radiation proctitis

Time Frame

late radiation proctitis is measured 9 months after the end of chemoradiation.

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 performance status score: 0~1 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

Learn more about this trial

Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

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