Clinical trial for Colorectal Carcinoma
Official title Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)
ClinicalTrials.gov ID: NCT06991465
What this study is testing
What is FOLFOX regimen?
an investigational radiosensitizing chemotherapy being studied for colorectal carcinoma is designed to combine fluorouracil, leucovorin, and oxaliplatin to damage cancer cell DNA and enhance the effect of radiation therapy
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see whether a hypofractionated (short-course) pelvic radiotherapy can safely allow patients who respond completely to skip surgery and keep their rectum.
- Who it's for
- Adults with locally advanced rectal adenocarcinoma who are candidates for pre‑operative radiation.
- What's involved
- Participants will receive a short course of high‑dose pelvic radiation and then be monitored with regular exams and imaging to check for cancer response, without planned surgery.
- Time commitment
- The radiation treatment lasts a few weeks, followed by scheduled follow‑up visits over several months to assess outcomes.
- Phase 2: a mid-size study of how well it works
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
- Histologically confirmed invasive adenocarcinoma of the rectum
- Pelvic MRI defined disease (at least one of the following): mesorectum involved or breached - includes involvement of adjacent organ(s) (T3-T4)
- Patients are considered medically fit for oncologic resection
- ECOG performance status 0 or 1
- No evidence of established metastatic disease (CT chest and abdomen)
You likely can't join if
- Previous chemotherapy
- Previous radiotherapy to the pelvis (including brachytherapy)
- Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of...
- T1 or T2 N0 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
- Histologically confirmed invasive adenocarcinoma of the rectum
- Pelvic MRI defined disease (at least one of the following): mesorectum involved or breached - includes involvement of adjacent organ(s) (T3-T4)
- 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 chemotherapy
- Previous radiotherapy to the pelvis (including brachytherapy)
- Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of randomisation)
- T1 or T2 N0 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
- Known dihydropyrimidine dehydrogenase deficiency
- 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 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 is enrolling
- 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, but 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?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.