Status:
UNKNOWN
Induction Chemotherapy,Radiochemotherapy, Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The use of capecitabine based preoperative chemoradiation and adjuvant chemotherapy is standard treatment of locally advanced rectal cancer. It has reduced local recurrence rate to less than 10%, but ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01489332
Start Date
October 1 2011
End Date
April 1 2018
Last Update
December 9 2011
Active Locations (1)
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1
Institute of Oncology
Ljubljana, Slovenia, 1000