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Fluorouracil

standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5; Complete responders and Non-complete responders

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; Complete responders and Non-complete responders

Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.

Complete responders and Non-complete responders

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5

Chemoradiation + EBRT Boost

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions

Chemoradiation + HDRBT Boost

Emma Starr, BHSc

Te Vuong, MD

A randomized study of 145 patients. Patients with a clinical T2-3 N0 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).

It is becoming clear that there is a now an international consensus that rectal cancer research efforts need to be more focused in optimizing a non-surgical approach. This concept is very relevant to an ageing patient population with multiple co-morbidities regularly seen at the Jewish General Hospital and across the province. After interim analysis on 40 patients of the pilot study a phase III study is proposed. We are therefore proposing a phase III multicentric study of 145 patients to compare the two best known radiation dose escalation strategies and to achieve a complete clinical response. 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). Patients that have a high risk of recurrence or with more advanced stages of the disease will be excluded from the study, as only the local disease is being treated. The primary outcome for this proposal is rectum preservation in treated patients.

No Surgery Trial / Two Dose-escalation Strategies

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

Time from date of randomization to either TME or death in the intention to treat population

Number of participants with Local recurrence as assessed by tests during follow-up visits.

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.

The time between date of randomization and date of death due to any causes.

Quality of life Questionnaires over different time point

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
No Surgery Trial / Two Dose-escalation Strategies	NCT03051464	Stage II Rectal...	Complete respon... Chemoradiation ... Chemoradiation ...	18 Years - 80 Years	Sir Mortimer B. Davis - Jewish General Hospital
No Surgery Trial / Two Dose-escalation Strategies	NCT03051464	Stage II Rectal...	Complete respon... Chemoradiation ... Chemoradiation ...	18 Years - 80 Years	Sir Mortimer B. Davis - Jewish General Hospital

Spots Global Cancer Trial Database for chemoradiation + ebrt boost