Non-operative Treatment, Organ Preservation, Rectal Cancer Patients, Rectal Cancer (Stage III), Stage II Rectal Cancer
Conditions
Keywords
rectal cancer, non-operative management, rectal preservation, organ preservation, brachytherapy boost for rectal cancer, low rectal cancer curative treatment, mid rectal cancer curative treatment, rectal brachytherapy
Brief 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).
Detailed description
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.
Interventions
PROCEDUREComplete responders and Non-complete responders
Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
RADIATIONChemoradiation + EBRT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
RADIATIONChemoradiation + HDRBT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Tumor less than 5 cm on its largest dimension * Tumor located at less than 10 cm from the anal verge * Tumor penetration less than 5 mm in the mesorectal fat * Tumor accessible for brachytherapy * Lumen accessible for colonoscopy * Patient should be a suitable candidate for brachytherapy and chemotherapy * Older than 18 years of age * Adequate birth control measures in women of childbearing potential * Written informed consent
Exclusion criteria
* Patients with previous pelvic radiation * Evidence of distant metastasis * Extension of malignant disease to the anal canal * Tumors staged as T4 * Tumors larger than 5 cm in length
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TME-free survival | 2 years post treatment | Time from date of randomization to either TME or death in the intention to treat population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Recurrence | 2 years post treatment | Number of participants with Local recurrence as assessed by tests during follow-up visits. |
| Disease-free survival | 5 years post treatment | 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 | 5 years post treatment | The time between date of randomization and date of death due to any causes. |
| Overall Quality of life | 5 years post treatment | Quality of life Questionnaires over different time point |
Countries
Canada, United States
Contacts
CONTACTSusanne Knoepfel
PRINCIPAL_INVESTIGATORTe Vuong, MD
Sir Mortimer Jewish General Hospital
Outcome results
None listed