Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
NCT ID: NCT01268943
Last Updated: 2015-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2010-11-30
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1000mg
capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine
oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
1200mg
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
1400mg
capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine
oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
1500mg
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Interventions
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Capecitabine
oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Capecitabine
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Capecitabine
oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Capecitabine
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* interval between surgery and enrollment no less than two week and no more than 3 months.
* KPS status no less than 70; life expectancy no less than 6 months.
* without life-threatening complications, such as severe hypertension, coronary heart disease, cerebral vascular disease, uncontrolled diabetes, etc.
* without severe drug allergy history.
* hemoglobin \>= 100g/L, white blood cell \>= 3.5\*10E9/L, neutrophil \>= 1.5\*10E9/L, platelet \>= 100\*10E9/L.
* Creatin \<= 1.5\* ULN(upper limit of normal), Total bilirubin \<= 2.5 ULN, AST and AST \<= 2.5\* ULN, AKP \<= 2.5\*ULN
* do not receive chemotherapy before six months from enrollment.
* no previously pelvic irradiation history
* informed consent signed
Exclusion Criteria
* allergy history to thymidine phosphorylase
* previous pelvic irradiation history
* receiving adjuvant chemotherapy in six months before enrollment
* active infection existed
* severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
* life expectancy less than 6 months
* estimated cannot finish treatment
* attend other clinical trials in four weeks before enrollment
* receive other anti-cancer treatment currently
* other conditions which regarded illegal by censors with full reasons. for example, some conditions may conflict from the protocol.
71 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Jing Jin, M.D.
vice chair of radiation department
Principal Investigators
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Jing Jin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
radiation department, cancer hospital, CAMS
Yexiong Li, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Radiation Department, Cancer Hospital, CAMS
Locations
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radiation department, Cancer Hospital, CAMS
Beijing, Beijing Municipality, China
Countries
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References
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Other Identifiers
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CH-GI-013
Identifier Type: -
Identifier Source: org_study_id
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