Overview

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

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
Summary
A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute of Oncology Ljubljana
Treatments:
Capecitabine
Criteria
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