Induction Chemotherapy,Radiochemotherapy, Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer
- Conditions
- Rectal Cancer
- Registration Number
- NCT01489332
- Lead Sponsor
- Institute of Oncology Ljubljana
- 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 has only had limited effect on overall survival due to the constantly high (more than 30%) rate of distant metastasis.
Complete eradication of the primary tumour observed in the histopathological specimen (pathological complete response, pCR) correlates with a favourable overall prognosis so obtaining a pCR might be beneficial. The aim of the study is to investigate whether the addition of capecitabine based chemotherapy before preoperative chemoradiation and also before the operation improves pathological complete remission rate in locally advanced rectal cancer with acceptable toxicity. Secondary objectives are to evaluate pathological downstaging rate, histopathological R0 resection rate,sphincter preservation rate, perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pathological complete remission rate (pCR) after the pathological examination of surgical speciments ie within 14 days after the operation
- Secondary Outcome Measures
Name Time Method Toxicity According to NCI-CTC (version 3.0): every week for 16 week preoperative, perioperative (0-30 days postoperative), early (30 days - 6 months postoperative), and late (more than 6 months postoperative) Number of patients with adverse events and the grade of adverse events
Histopathological R0 resection rate after the pathological examination of resected speciments ie within 14 days after the operation Loco-regional failure rate after 3y and 5y of operation Disease-free survival after 3y and 5y of operation Quality of life before the treatment, after 1,and 3 years of the operation We will use EORTC questionnaires QLQ C30 and C38
Overall survival after 3y and 5y of the operation
Trial Locations
- Locations (1)
Institute of Oncology
🇸🇮Ljubljana, Slovenia