BridgeMD
A multi-centred, partially randomised, patient-preference trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer.
EU CTIS ID: 2024-517410-15-01
What this study is testing
The aim of this study is to determine oncological safety of rectal preserving therapy for intermediate-risk early rectal cancer by comparing completion surgery with adjuvant chemoradiotherapy and surveillance after local excision.
- Therapeutic confirmatory (Phase III)
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
- The patient has had an endoluminal local excision (by TEM, TAMIS, TSPM, EMR, ESD, endoscopic full thickness resection, endoscopic intramuscular dissection or polypectomy) of an early rectal cancer without carcinoma in the resection plane.
- Male or female, age > 18 years.
- Life expectancy of at least 12 months.
- Medically fit (WHO 0-2) to undergo radical surgery and/or radiation.
- No contraindications to chemotherapy, including adequate blood counts; white blood count >= 4.0 x 10 9/l, platelet count >=100 x 109/l, clinical acceptable haemoglobin levels, bilirubin < 35 umol/l, creatinine levels indicating renal clearance of >=50 ml/min
- The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
You likely can't join if
- Incomplete or inconclusive resection margin with macroscopic residual tumour.
- Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- History of severe and unexpected reactions to fluoropyrimidine therapy.
- Hypersensitivity to capecitabine.
- Patients with severe hepatic impairment.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
See the full eligibility criteria
Who can join
- The patient has had an endoluminal local excision (by TEM, TAMIS, TSPM, EMR, ESD, endoscopic full thickness resection, endoscopic intramuscular dissection or polypectomy) of an early rectal cancer without carcinoma in the resection plane.
- Male or female, age > 18 years.
- Life expectancy of at least 12 months.
- Medically fit (WHO 0-2) to undergo radical surgery and/or radiation.
- No contraindications to chemotherapy, including adequate blood counts; white blood count >= 4.0 x 10 9/l, platelet count >=100 x 109/l, clinical acceptable haemoglobin levels, bilirubin < 35 umol/l, creatinine levels indicating renal clearance of >=50 ml/min
- The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
- Written (signed and dated) informed consent and be capable of co-operating with protocol.
- Patients with unreliable resection planes (EMR/ESD) are eligible for randomisation if no macroscopic residual tumour is found during endoscopy.
- Patients with carcinoma in the resection plane are eligible for randomisation after re-excision that shows no carcinoma in the resection plane.
- Only lesions for which TME surgery is indicated can be included (if a partial mesorectal excision (PME) is indicated the patient should be excluded).
- Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: T1 with size 3-5 cm of carcinoma or pT1, maximum size of carcinoma of 3 cm, with at least poor differentiation, Haggit 4 and/or sm3, tumour budding, lymphatic and/or venous invasion.
- Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: pT2, maximum size of carcinoma of 3 cm, well/moderate differentiated and without lymphatic or venous invasion.
- Complete colonoscopy, without synchronous colorectal cancer.
- cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features. Staging done within 6 weeks before randomisation.
- Adequate distant staging (X-thorax or CT-thorax and CT-abdomen) without signs of distant metastasis (cM0).
What rules you out
- Incomplete or inconclusive resection margin with macroscopic residual tumour.
- Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- History of severe and unexpected reactions to fluoropyrimidine therapy.
- Hypersensitivity to capecitabine.
- Patients with severe hepatic impairment.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Patients known with dihydropyrimidine dehydrogenase deficiency.
- Any contra-indications to undergo MRI imaging.
- T1 tumour with carcinoma <3 cm, moderate/well differentiated, without sm3/Haggit4, tumour budding, venous or lymphatic invasion.
- T1 tumour with carcinoma of >5 cm and T2 tumour with carcinoma of >3 cm.
- Presence of metastatic disease or recurrent rectal tumour.
- Previous pelvic radiation.
- Treatment with any other investigational agent, or participation in another clinical trial that might influence study outcomes within 28 days prior to enrolment.
- Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years.
- Pregnancy, breast-feeding or fertile women without active birth control.
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (<6 months prior to randomisation), myocardial infarction (<6 months prior to randomisation), unstable angina, New York Heart Association (NYHA) grade II or higher, congestive heart failure, serious cardiac arrhythmia requiring medication.
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, 18-64 years, 65+ 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.