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

November 30, 2014 updated by: Zhen-zhou Yang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 To evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemoradiotherapy
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
Drug: Chemoradiotherapy
S-1 CCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD)
Time Frame: 6weeks (42 days)
6weeks (42 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose Limiting Toxicities (DLTs)
Time Frame: 6weeks (42 days)
6weeks (42 days)
Quality of Life
Time Frame: 6weeks (42 days)
6weeks (42 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 26, 2014

First Posted (Estimate)

October 28, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 30, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP03182014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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