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

NCT02277158 | Unknown Phase 1

• 1 other identifier: DP03182014
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Rectal Cancer

Keywords

Rectal cancer; S-1; Chemoradiotherapy; Phase I

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  6weeks (42 days)

Secondary Outcomes (2)

• Dose Limiting Toxicities (DLTs)

  6weeks (42 days)

• Quality of Life

  6weeks (42 days)

Study Arms (1)

Chemoradiotherapy

EXPERIMENTAL

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

Interventions

Chemoradiotherapy DRUG

S-1 CCRT

Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• R0 resection of histologically proved stage II/III rectal cancer;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Zhenzhou-Yang

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Zhenzhou Yang, MD, PhD

CONTACT

＋86-02368811229; yangzz1970@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 28, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

CN (1)