At a glance
ClinicalIndex Comparison Record- ✓T2-T3 rectal cancer staged by MRI or endoscopic ultrasound
- ✓N0 nodal staging by MRI or EUS/TRUS
- ✓No metastatic lesions
- ✓Tumor occupies less than half of circumference
- ✕Previous pelvic radiation
- ✕Evidence of distant metastasis
- ✕Extension of malignant disease to anal canal
- ✕T4 tumors
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer
In Brief
A Phase 3 clinical trial evaluating Complete responders and Non-complete responders, Chemoradiation + EBRT Boost, and 1 other intervention for Stage II Rectal Cancer and 4 related conditions. Currently recruiting, targeting 131 participants across 4 sites in 2 countries.
Detailed Summary
A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).
Study Details
Timeline
Interventions
Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions