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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277158
Recruitment Status : Unknown
Verified November 2014 by Zhen-zhou Yang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : October 28, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Zhen-zhou Yang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Chemoradiotherapy Phase 1

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 To evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

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




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 6weeks (42 days) ]

Secondary Outcome Measures :
  1. Dose Limiting Toxicities (DLTs) [ Time Frame: 6weeks (42 days) ]
  2. Quality of Life [ Time Frame: 6weeks (42 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277158


Contacts
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Contact: Zhenzhou Yang, MD, PhD +86-02368811229 yangzz1970@163.com

Locations
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China, Chongqing
Zhenzhou-Yang Recruiting
Chongqing, Chongqing, China
Contact: Zhenzhou Yang, PHD       yangzz1970@163.com   
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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Responsible Party: Zhen-zhou Yang, Professor, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT02277158    
Other Study ID Numbers: DP03182014
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Keywords provided by Zhen-zhou Yang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:
Rectal cancer
S-1
Chemoradiotherapy
Phase I
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases