Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer

Institute of Oncology Ljubljana

Status and phase

Completed

Phase 2

Conditions

Resectable Rectal Cancer Clinical Stage II and III

Treatments

Drug: Capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT01152710

139/03/06

Details and patient eligibility

About

A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.

Full description

Preoperative chemoradiation has become a standard part of treatment protocols in stage II and III rectal cancer. Compared to postoperative chemoradiotherapy, the advantage of preoperative application of chemotherapeutics and irradiation includes improved compliance, reduced toxicity and downstaging of the tumour in a substantial number of patients. The latter may enhance the rate of curative surgery, permit sphincter preservation in patients with low-sited tumours and have a positive impact on the quality of life of these patients. Orally administered capecitabine (Xeloda®, Hoffmann - La Roche Ltd, Basel, Switzerland) mimics the pharmacokinetics of continuous 5-FU infusion and makes chemoradiotherapy more patient-friendly. The mechanism of capecitabine activation, preferably in tumour cells, may further enhance its efficacy and tolerability, offering the potential for an enhanced therapeutic ratio.The aim of the present phase II study was to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in patients with locally advanced rectal cancer. The primary endpoint of the study is a pathologically determined complete remission rate (pCR) of the disease locally and regionally. Secondly, the rate of sphincter preservation in low-sited tumours, overall downstaging rate,toxicity and survival parameters will be analysed.

Enrollment

57 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

histologically verified adenocarcinoma of the rectum,
resectable clinical stage II or III (IUCC TNM classification 2002);
no prior radiotherapy and/or chemotherapy;
World Health Organisation (WHO) performance status < 2;
age at diagnosis of 18 or older;
and adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease).

Exclusion criteria