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New treatment option for Colorectal Carcinoma
Official title Patients With Rectal Cancer: a "Wait-and-see" Approach
ClinicalTrials.gov ID: NCT03001362
What this study is testing
- What it's testing
- Patients with histologically proven adenocarcinoma of the rectum will receive pelvic radiotherapy to a dose of 45Gy in 25 fractions with a tumor boost to a dose of 9Gy in 5 fractions (thus total of 54Gy/30Fx to the primary tumor), combined with radio sensitizing chemotherapy. Patients will then be closely monitored, through endoscopy and imaging, for response to treatment and relapse.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Pelvic MRI defined disease (at least one of the following):
- mesorectum involved or breached - includes involvement of adjacent organ (s) (T3-T4)
- involvement of muscularis propria (T2)
- extra-mural vascular invasion
- tumour deposit within the mesorectum
You likely can't join if
- Previous radiotherapy to the pelvis (including brachytherapy)
- Enlarged extramesorectal nodes
- Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of...
- T1N0 disease without extra-mural venous invasion
- Unequivocal evidence of metastatic disease (includes resectable metastases)
- Major impairment of bowel function without defunctioning stoma/ileostomy (baseline grade 3 diarrhoea or clinically significant faecal incontinence)
See the full eligibility criteria
- Pelvic MRI defined disease (at least one of the following):
- mesorectum involved or breached - includes involvement of adjacent organ (s) (T3-T4)
- involvement of muscularis propria (T2)
- extra-mural vascular invasion
- tumour deposit within the mesorectum
- one or more involved mesorectal lymph node
- Patients are considered medically fit for oncologic resection
- ECOG performance status 0 or 1
- No evidence of established metastatic disease (CT chest and abdomen)
- Absolute neutrophil count \>1.5x109/L; platelets \>100x109/L,
- Serum transaminase \<3 x ULN;
- Adequate renal function (Cockroft Gault estimation \>50 mL/min)
- Bilirubin \<1.5 x ULN
- Ability to comply with oral medication
- Willingness and ability to give informed consent and comply with treatment and follow up schedule
- Age 18 or over
- Previous radiotherapy to the pelvis (including brachytherapy)
- Enlarged extramesorectal nodes
- Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of randomisation)
- T1N0 disease without extra-mural venous invasion
- Unequivocal evidence of metastatic disease (includes resectable metastases)
- Major impairment of bowel function without defunctioning stoma/ileostomy (baseline grade 3 diarrhoea or clinically significant faecal incontinence)
- History of another malignancy within the last 5 years except successfully treated basal cell cancer of skin or carcinoma in situ of uterine cervix.
- Known dihydropyrimidine dehydrogenase deficiency
- Known Gilberts disease (hyperbilirubinaemia)
- Taking warfarin or phenytoin or sorivudine
- Gastrointestinal disorder which would interfere with oral therapy and its bioavailability
- Pregnant, lactating, or pre-menopausal women not using adequate contraception
- Unfit to receive any study treatment or subsequent surgical resection
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.