Induction Chemotherapy, Preoperative Radiochemotherapy, Consolidation Chemotherapy, Operation and Adjuvant Chemotherapy in the Treatment of Locally Advanced Rectal Cancer- OIGIT 5-01 Phase II Trial
Inclusion Criteria:
- Male or female patients with histologically proven adenocarcinoma of the rectum
(tumour located below the peritoneum),
- T3/4 or any node positive disease (clinical stage according the TNM classification
system)
- No evidence of metastatic disease.
- The disease must be considered either resectable at the time of entry or thought to
become resectable after preoperative chemoradiation.
- Age 18 years and more
- WHO Performance Status 0-2
- No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
- Adequate hematological, hepatic and renal function Ability to swallow tablets
- Signed informed consent
- Patients must be willing and able to comply with the protocol for duration of the
study
Exclusion Criteria:
- Malignancy of the rectum other than adenocarcinoma
- Any unrested synchronous colon cancer
- Other co-existing malignancy or malignancy within the past 5 years, with the
exception of adequately treated in situ carcinoma of the cervix or basal cell
carcinoma of the skin
- Significant heart disease (uncontrolled hypertension despite of medication (> 150/100
mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction
within the past 1 year prior the study entry, history of significant ventricular
arrhythmia requiring treatment)
- Pregnant or lactating patient
- Females with a positive or no pregnancy test unless childbearing potential can be
otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy)