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Phase 1 N=18 Treatment

Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

Rectal Neoplasms

Enrolled (actual)
18
Serious AEs
16.7%
Results posted
Mar 2015
Primary outcome: Primary: Dose Related Toxicity — 1; 0; 0; 3 event

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Capecitabine (Drug)
Age
Older Adult · 71+ yrs
Sex
All
Sponsor
Chinese Academy of Medical Sciences
Primary completion
Jan 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Dose Related Toxicity
1; 0; 0; 3

Summary

The purpose of this study is to seek the proper dose of capecitabine in post-operative concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical surgery, and evaluate the toleration of this modality in such patients.

Eligibility Criteria

Inclusion Criteria

  • rectal adenocarcinoma, pathological stage II/III(T3-4 or N+, UICC 2002), radical surgery received.
  • 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

  • other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01268943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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