Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 1

Conditions: Rectal Neoplasms

Treatments: Drug: capecitabine; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01584544

CH-GI-024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 5 patient groups

1000mg

Experimental group

Description:

capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.

Treatment:

Drug: capecitabine

1200mg

Experimental group

Description:

capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Treatment:

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine

1350mg

Experimental group

Description:

capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Treatment:

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine

1500mg

Experimental group

Description:

capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Treatment:

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine

1650mg

Experimental group

Description:

capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Treatment:

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine