Rectal cancer
Conditions
Interventions
Phase III trial randomizing between EBRT (13x3 Gy) and EBRT+HDR-BT (13x3 Gy followed by 3x7 Gy brachytherapy)
Sponsors
LUMC
Eligibility
Inclusion criteria
Inclusion criteria: • Adenocarcinoma of the rectum • WHO performance status 0-3 • Frail patients unfit for surgery or refusing surgery (see §4.3) • Tumors with a sufficient lumen to allow the positioning of the flexible, multichannel applicator • Signed informed consent prior to start of protocol specific procedures
Exclusion criteria
Exclusion criteria: • Extramesorectal (e.g. iliac, lateral) pelvic lymph node involvement • 4 or more lymph nodes > 1 cm disease on MRI (gross N2 disease) • M1 disease • Extension of tumour into the anal canal • Tumor > 2/3 of the circumference • Previous pelvic irradiation • Prior chemotherapy • Prior surgery for rectal cancer, except local excision > 3 months before start of EBRT • Contra-indication for endoscopic placement of gold-markers such as coagulopathy (prothrombin time 50 seconds) or anticoagulantia (marcoumar, sintrom or new oral anticoagulants) that cannot be stopped.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete clinical response (cCR) at 26 weeks after EBRT for the control group and at 26 weeks after the last brachytherapy fraction for the intervention group. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Acute and late toxicity (CTCAE v5) • HRQL and functional status at 1 and 2 year • Sustainability of response at 2 years • Overall survival at 2 years | — |
Contacts
Public ContactClinical Research Center Heelkunde LUMC
LUMC
Outcome results
None listed