Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 57
- Locations
- 2
- Primary Endpoint
- complete pathological remission rate
Study Overview
Brief Summary
A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •A history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix
Outcomes
Primary Outcomes
complete pathological remission rate
Time Frame: 9 weeks
after pathological examination of resected specimen
Secondary Outcomes
- the rate of sphincter preservation in low-sited tumours(9 weeks)
- toxicity of combined modality treatment (Number of Participants with Adverse Events)(5 weeks)
- long-term rectal and urogenital morbidity(2 years after the surgery)
- overall downstaging rate(9 weeks)
- overall survival(5 years)
- local control(5 years)
- relapse-free survival(5 years)