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Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chemoradiotherapy
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal cancer, S-1, Chemoradiotherapy, Phase I

Eligibility Criteria

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

Inclusion Criteria:

  • R0 resection of histologically proved stage II/III rectal cancer;
  • 18-75 years old;
  • No previous radiotherapy or chemotherapy for rectal cancer;
  • Performance status of ECOG 0,1;

  • Adequate organ function defined as below:

    i. WBC ≥ 4,000/mm^3 ii. ANC ≥ 1,500/mm^3 iii. Hemoglobin ≥ 10g/dL iv. Platelet ≥ 100,000/m^3 v. Total bilirubin ≤ 1.5ULN vi. AST/ALT ≤ 1.5ULN vii. Serum creatinine ≤ 1.5ULN or creatinine clearance rate ≥ 60ml/min、Urea nitrogen ≤ 1.5ULN viii. Protein in urine dipstick test<1+; if the test result >1+ ,total protein in urea must <500mg within 24 hours

  • Able to receive oral administration
  • Informed consent

Exclusion Criteria:

  • Hypersensitive to S-1 or its excipients
  • Pulmonary fibrosis or interstitial pneumonitis found within 28 days prior to registration
  • Significant co-morbid medical conditions, including, but not limited to, heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
  • Received any investigational drug or anti-cancer agent
  • Pregnant or lactating female or pregnancy test positive
  • Severe mental disorder
  • Judged ineligible by physicians for participation in the study due to safety concern.

Sites / Locations

  • Zhenzhou-YangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemoradiotherapy

Arm Description

There are four dose levels and one arm only. Level 1: S-1, 50 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 2: S-1, 65 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 3: S-1, 80 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 4: S-1, 90 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD)

Secondary Outcome Measures

Dose Limiting Toxicities (DLTs)
Quality of Life

Full Information

First Posted
October 22, 2014
Last Updated
November 30, 2014
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02277158
Brief Title
Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.
Official Title
A Phase I Study of Concurrent Radiotherapy and Tegafur, Gimeracil and Oteracil Potassium Capsule(S-1) as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer
Detailed Description
This stage I study is designed to evaluate the appropriate dose of S-1 plus radiotherapy for patients with R0 resection of rectal cancer for stage II-III patients(AJCC 7th). To evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal cancer, S-1, Chemoradiotherapy, Phase I

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiotherapy
Arm Type
Experimental
Arm Description
There are four dose levels and one arm only. Level 1: S-1, 50 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 2: S-1, 65 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 3: S-1, 80 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 4: S-1, 90 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks
Intervention Type
Drug
Intervention Name(s)
Chemoradiotherapy
Intervention Description
S-1 CCRT
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
Time Frame
6weeks (42 days)
Secondary Outcome Measure Information:
Title
Dose Limiting Toxicities (DLTs)
Time Frame
6weeks (42 days)
Title
Quality of Life
Time Frame
6weeks (42 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: R0 resection of histologically proved stage II/III rectal cancer; 18-75 years old; No previous radiotherapy or chemotherapy for rectal cancer; Performance status of ECOG 0,1; Adequate organ function defined as below: i. WBC ≥ 4,000/mm^3 ii. ANC ≥ 1,500/mm^3 iii. Hemoglobin ≥ 10g/dL iv. Platelet ≥ 100,000/m^3 v. Total bilirubin ≤ 1.5ULN vi. AST/ALT ≤ 1.5ULN vii. Serum creatinine ≤ 1.5ULN or creatinine clearance rate ≥ 60ml/min、Urea nitrogen ≤ 1.5ULN viii. Protein in urine dipstick test<1+; if the test result >1+ ,total protein in urea must <500mg within 24 hours Able to receive oral administration Informed consent Exclusion Criteria: Hypersensitive to S-1 or its excipients Pulmonary fibrosis or interstitial pneumonitis found within 28 days prior to registration Significant co-morbid medical conditions, including, but not limited to, heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes Received any investigational drug or anti-cancer agent Pregnant or lactating female or pregnancy test positive Severe mental disorder Judged ineligible by physicians for participation in the study due to safety concern.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenzhou Yang, MD, PhD
Phone
＋86-02368811229
Email
yangzz1970@163.com
Facility Information:
Facility Name
Zhenzhou-Yang
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenzhou Yang, PHD
Email
yangzz1970@163.com

12. IPD Sharing Statement

Learn more about this trial

Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.

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