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Can we Save the rectum by watchful waiting or transanal surgery following short- or long-course radioTherapy and Additional local oR systemic Treatment for early-stage REctal Cancer?
EU CTIS ID: 2024-514620-17-00
What this study is testing
The assessment of successful organ preservation rates in the concerning study arms.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Biopsy proven adenocarcinoma of the rectum
- Early- or early-intermediate stage rectal cancer, defined as Magnetic Resonance Imaging (MRI)-T1-3ab, N0/N1 (≤3 mesorectal lymph nodes ≤8mm), MX/M0 rectal tumour
- Tumour located in the distal or mid-rectum for which TME-surgery is required
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age 18 years or older
- Patient able and willing to provide written informed consent for the study
You likely can't join if
- Concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse < 3 years or lead to death < 5 years
- Definite evidence of regional or distant metastases (M1) in opinion of MDT
- Pregnant or lactating women.
- Pre-existing faecal incontinence, leading to an expected impaired quality of life post-treatment
- Tumour located in the proximal rectum for which PME-surgery will be sufficient
- MRI suspicious lymph nodes cN1 (1-3 lymph nodes > 8mm) or cN2
See the full eligibility criteria
- Biopsy proven adenocarcinoma of the rectum
- Early- or early-intermediate stage rectal cancer, defined as Magnetic Resonance Imaging (MRI)-T1-3ab, N0/N1 (≤3 mesorectal lymph nodes ≤8mm), MX/M0 rectal tumour
- Tumour located in the distal or mid-rectum for which TME-surgery is required
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age 18 years or older
- Patient able and willing to provide written informed consent for the study
- Concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse < 3 years or lead to death < 5 years
- Definite evidence of regional or distant metastases (M1) in opinion of MDT
- Pregnant or lactating women.
- Pre-existing faecal incontinence, leading to an expected impaired quality of life post-treatment
- Tumour located in the proximal rectum for which PME-surgery will be sufficient
- MRI suspicious lymph nodes cN1 (1-3 lymph nodes > 8mm) or cN2
- MRI extramural vascular invasion (mriEMVI) present (defined by protocol guidelines)
- MRI defined mucinous tumour
- Mesorectal fascia threatened by tumour (≤ 1mm on MRI)
- Any form of (endoscopic/surgical) local excision of the primary tumour prior to study-entry
- Prior pelvic radiotherapy
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.