Clinical trial NCT01584544: Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer
Official title: Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rectal Neoplasms
Keywords: rectal neoplasms
aged
chemoradiotherapy
clinical trials, phase I
capecitabine
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2012-04-25
Enrollment: 24
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: It is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage II/III rectal cancer patients. But elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility.

Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out.

The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.

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

Primary outcomes:
measure: Number of Participants Experienced Dose Limited Toxicity
timeFrame: up to 7 weeks from start of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: radiation department, Cancer Hospital, CAMS
state: Beijing
Study officials:
affiliation: Chinese Academic Medical Science
name: Jing Jin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academic Medical Science
name: Yexiong Li, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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