Phase 1 N=24 Treatment

Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

Rectal Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT01584544 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Apr 2015

Primary outcome: Primary: Number of Participants Experienced Dose Limited Toxicity — 0; 1; 1; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: capecitabine (Drug)
Age: Older Adult · 75+ yrs
Sex: All
Sponsor: Chinese Academy of Medical Sciences
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Experienced Dose Limited Toxicity	0; 1; 1; 0; 1	—

Summary

This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.

Eligibility Criteria

Inclusion Criteria

rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
KPS status no less than 70; Charlson comorbidity no more than 3.
life expectancy more than 6 months.
hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
do not have allergy history to thymidine phosphorylase.
do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
no previously pelvic irradiation history
informed consent signed

Exclusion Criteria

other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
previous pelvic irradiation history
receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
allergy history to thymidine phosphorylase
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.
anticipate other clinical trials in four weeks before enrollment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01584544). 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.