Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer
A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.
Resectable Rectal Cancer Clinical Stage II and III
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer|
- complete pathological remission rate [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]after pathological examination of resected specimen
- the rate of sphincter preservation in low-sited tumours [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]after the operation
- toxicity of combined modality treatment (Number of Participants with Adverse Events) [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]During preoperative treatment, patients will be evaluated weekly for acute toxicity and compliance with the protocol. Clinical examination and complete blood count will be performed and body weight was measured. Toxic side effects will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) (version 2.0). Patients will be followed every three month for the first two years after the last cycle of adjuvant chemotherapy and thereafter every six month up to 5th year.
- overall downstaging rate [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]after the pathological examination of resected specimen
- overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Overall survival is defined as the time from inclusion to the date of death from any cause or to the date of last follow-up.
- local control [ Time Frame: 5 years ] [ Designated as safety issue: No ]Local control is defined as the time from inclusion to the date of local recurrence
- relapse-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Relapse-free survival iss defined as the time from inclusion to the first occurrence of disease relapse (local or distant), death or date of last follow-up.
- long-term rectal and urogenital morbidity [ Time Frame: 2 years after the surgery ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Study Completion Date:||April 2010|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
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.