Status:
COMPLETED
Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Resectable Rectal Cancer Clinical Stage II and III
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- A history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01152710
Start Date
June 1 2004
End Date
April 1 2010
Last Update
June 29 2010
Active Locations (1)
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1
Institute of Oncology
Ljubljana, Slovenia, Slovenia, 1000