rectal cancer
Conditions
Interventions
Patients with distal rectal cancer will be randomly assigned to receive neoadjuvant chemoradiation with consolidation chemotherapy using 1 or 2 drugs during the consolidation treatment:
2 drugs arm:
1 drug arm:
RT (54Gy) plus daily concomitant capecitabine 825mg/m2 bid, followed by capecitabine 2000mg/m2/day for 14 days in a 21 days cycle for 4 cycles (12 weeks), starting 1 week after radiothera
Sponsors
Hospital Alemão Oswaldo Cruz
Hospital Alemão Oswaldo Cruz
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years; 2. ECOG 0-2 or KPS=70; 3. Primary rectal adenocarcinoma (biopsy confirmed) within the reach of digital rectal examination (at least lower tip/border) by the attending colorectal surgeon; 4. Endoscopic documentation; 5. Abdominal and chest CT scans showing no evidence of metastatic disease; 6. High-resolution magnetic resonance images performed at either 1.5T or 3.0T system using a phased array surface coil with: sagittal T2 images including the anal verge and the sacrum; axial oblique T2 weighted images acquired in a plane perpendicular to the long axis of the rectal wall guided by the sagittal images; coronal images acquired in parallel to the anal canal plane. Small field of view (16-18cm), 3mm section thickness, increased matrix size and increased number of signal averages are required; 7. Radiological defining criteria (centralized): a. Lower edge of tumor at the level (max. 1cm distance) or below the anorectal ring defined at sagittal or coronal views; b. mrT2, mrT3 (any subclassification) c. mrN0-1 (=3 radiologically positive lymph nodes) d. mrEMVI: any status e. mrMRF: any status
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. ECOG =3 or KPS<70 3. Unwilling to consent 4. Metastatic disease (any kind; internal iliac and obturator nodes are considered local disease and not metastatic disease and therefore will not be considered as exclusion criteria) 5. mrT4 or mrN2 6. Previous pelvic irradiation 7. Baseline neuropathy 8. Receiving treatment of other anti-cancer drug or methods 9. Presence of uncontrolled life threatening diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decision to Watch and Wait due to clinical complete response achieved at 18 weeks from last date of radiation using clinical (DRE), endoscopic and radiological criteria (mrTRG grade) or near-complete clinical response (no progressive disease clinically, endoscopically or radiologically) | — |
Countries
Argentina, Brazil, Colombia, Costa Rica, Panama
Contacts
Public ContactGuilherme São Julião
Outcome results
None listed