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).
Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound
Rectal cancer staged as N0-1 by MRI or EUS/TRUS
No metastatic lesion
Rectal tumor occupying less than half of the circumference
Patients with previous pelvic radiation
Evidence of distant metastasis
Extension of malignant disease to the anal canal
Tumors staged as T4
Parallel
Complete responders and Non-complete responders
Procedure/SurgeryPatients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
Chemoradiation + EBRT Boost
Radiation45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
Chemoradiation + HDRBT Boost
Radiation45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions
TME-free survival
Time from date of randomization to either TME or death in the intention to treat population
Local Recurrence
Number of participants with Local recurrence as assessed by tests during follow-up visits.
Disease-free survival
The time between the date of randomization and recurrence, either in the pelvis or metastases. Patients without an event will be censored at the last date the patient was known to be disease-free.
Overall survival
The time between date of randomization and date of death due to any causes.
Overall Quality of life
Quality of life Questionnaires over different time point
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