Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.
NCT ID: NCT02277158
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
18 participants
INTERVENTIONAL
2014-11-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Chemoradiotherapy
S-1 CCRT
Interventions
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Chemoradiotherapy
S-1 CCRT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
Responsible Party
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Zhen-zhou Yang
Professor
Locations
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Zhenzhou-Yang
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DP03182014
Identifier Type: -
Identifier Source: org_study_id