A Phase 2 interventional study of intensified preoperative chemotherapy in Rectal Cancer, sponsored by Institute of Oncology Ljubljana. Status unknown at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-09.
Sponsored by Institute of Oncology Ljubljana · Phase 2, Interventional, and Treatment
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.
1,761 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 60 is close to the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Institute of Oncology Ljubljana is the lead sponsor of 88 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
capecitabine 1250 mg/m² p.o. twice daily for 14 consecutive days, 7 days rest for one cycle; radiotherapy: 50.4 Gy to the pelvis (25x 1.8 Gy on days 1-33, excluding weekends) plus 5.4 Gy on days 36-38 as a boost to the primary tumour (3 fractions of 1.8 Gy).Three- dimensional CT planing and a four field box technique with high energy photons (15 MV) will be used. capecitabine 825 mg/m² p.o. twice daily on days 1-38 (including weekends), One week after completion of radiochemotherapy patients receive 2 cycles of capecitabine based chemotherapy (1250 mg/m² p.o. twice daily for 14 consecutive days every three weeks). Radical surgery (TME): to be undertaken 8 weeks following completion of chemoradiation Postoperative treatment:capecitabine 1250 mg/m² p.o. twice daily for 14 consecutive days every three weeks; 3 cycles (R0 beginning 6-8 weeks after surgery
Pathological complete remission rate (pCR)
Time frame: after the pathological examination of surgical speciments ie within 14 days after the operation
Toxicity
Number of patients with adverse events and the grade of adverse events
Time frame: 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)
Histopathological R0 resection rate
Time frame: after the pathological examination of resected speciments ie within 14 days after the operation
Loco-regional failure rate
Time frame: after 3y and 5y of operation
Disease-free survival
Time frame: after 3y and 5y of operation
Overall survival
Time frame: after 3y and 5y of the operation
Quality of life
We will use EORTC questionnaires QLQ C30 and C38
Time frame: before the treatment, after 1,and 3 years of the operation
This study is status unknown, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Institute of Oncology Ljubljana