Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Confirmed diagnosis of inoperable/recurrent rectal cancer
Age > 18 years
At least 1 measurable lesion should be present
WHO performance score < 2
Life expentancy of at least 12 weeks
Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
Documented informed consent to participate in the trial

Exclusion Criteria:

Previous systemic chemotherapy
Previous radiotherapy to the planned exposure area
Subjects with distant metastases
(a)white blood cell < 4.0x109/L (unless absolute neutrophil count is >2.0x109/L or (b) Platelet count < 100x109/L
Serum creatinine above the upper limit of the normal range
(a) Serum bilirubin > 1.25 times the upper limit of the normal range or (b) Asparate aminotransferase(AST) or Alanine amiontransferase (ALT) >2.5 times the upper limit of the normal range
Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial period
Pregnancy or breast feeding. Women of childbearing age must use effective contraception
Previous or current malignancies at other sites, with the exception of adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
Patient participation in other studies