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

Rectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02277158
• Other study ID #: DP03182014
• Status: Recruiting
• Phase: Phase 1
• First received: October 22, 2014
• Last updated: November 30, 2014
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Zhenzhou Yang, MD, PhD
• Phone: +86-02368811229
• Email: yangzz1970[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 To evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Chemoradiotherapy
S-1 CCRT

Locations

Country	Name	City	State
China	Zhenzhou-Yang	Chongqing	Chongqing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)		6weeks (42 days)	Yes
Secondary	Dose Limiting Toxicities (DLTs)		6weeks (42 days)	Yes
Secondary	Quality of Life		6weeks (42 days)	No