Locally advanced non-resectable rectal cancer MedDRA version: 6.0 Level: LLT Classification code 10038050
Conditions
Interventions
Trade Name: Uftoral
Product Name: Uftoral
Product Code: 20662
Pharmaceutical Form: Capsule*
INN or Proposed INN: Tegafur, Uracil
Trade Name: Eloxatin
Product Name: Eloxatin
Pharmaceutical Form: Powde
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven adenocarcinoma of the rectum - Locally advanced (surgically unresectable) or recurrent rectal cancer - Primarily unresectable: fixation of tumor to sacral bone or pelvic wall or invation into pelvic soft tissue (e.g. nerves, blood vessels, bladder, prostate) - WHO perforamnce 0-2 - Disease confined to the pelvis - A life expectancy of at least 3 months - Age >18 years -Adequate hematological (White Blood Cell counts (WBC) =3.0 x 109/l and platelets =100 x 109/l), hepatic (bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Adjuvant chemotherapy or immunotherapy within 12 months - Previous RT to the pelvic area - Exploratory laparotomy within 4 weeks - Patients with any contraindication to the planned chemotherapy or RT - Other active malignant disease within 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix - Other experimental theapy while treated according to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess toxicity and feasibility of TEGAFOX followed by radiochemotherapy (UFT + oxaliplatin) in patients with LARC;Secondary Objective: The number of patients achieving complete pathological response (pCR) Survival;Primary end point(s): Phase I Toxicity and feasibility Phase II Number of patients achieving complete pathological response (pCR) Survival | — |
Countries
Denmark
Outcome results
None listed