Stage II Rectal Cancer Clinical Trial
— MorpheusOfficial title:
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
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).
Status | Recruiting |
Enrollment | 145 |
Est. completion date | January 2030 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound - Rectal cancer staged as N0 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Sir Mortimer B. Davis - Jewish General Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TME-free survival | Time from date of randomization to either TME or death in the intention to treat population | 2 years post treatment | |
Secondary | Local Recurrence | Number of participants with Local recurrence as assessed by tests during follow-up visits. | 2 years post treatment | |
Secondary | 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. | 5 years post treatment | |
Secondary | Overall survival | The time between date of randomization and date of death due to any causes. | 5 years post treatment | |
Secondary | Overall Quality of life | Quality of life Questionnaires over different time point | 5 years post treatment |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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