Endorectal Brachytherapy for Rectal Cancer
Key facts
- Who runs it
- University Hospital, Bordeaux
- Where
- France2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Suspended
- Phase
- Phase 2
- People taking part
- 31 people, planned
- Started
- 31 Jan 2024
- Expected to end
- Jan 2027
- Type of study
- Interventional
- Treatments tested
- Endorectal brachytherapy
- Record updated
- 1 August 2025
- Why it stopped
- Unknown time frame for availability of new endorectal probes
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- Histologically proven rectal adenocarcinoma
- Tumor cT2T3Tumor N0 or N1, M0
- Size < 6cm and < 50% of circumference at initial workup, location ≤ 10 cm from anal margin
- Partial response assessed on MRI 3-8 weeks after completion of external beam radiation therapy
- Resolved rectal toxicity from external radiotherapy (grade ≤ 1) at the time of inclusion
- ECOG performance index ≤ 2
- Patient ≥ 18 years of age
- Patient likely to receive radiation therapy
- Effective contraception for patients of childbearing potential: male patients and women of childbearing potential must agree to use two medically validated methods of contraception (one for the patient and one for the partner) during treatment and at least until 6 months after the last treatment
- Informing the patient and obtaining free, informed and written consent, signed by the patient and the investigator
- Subject affiliated or beneficiary of a social security system of a member state of the European Community (article L1121-11 of the Public Health Code)
Who cannot take part
- Contraindication to radiotherapy
- Unusual and unresolved rectal toxicity from external radiation therapy (> grade 1) at the time of inclusion
- Metastatic disease
- T1 or T4 tumor
- Tumor size > 6 cm or > 50% of circumference at initial workup
- Invaded external sphincter or levator ani
- N2 tumor (> 3 positive nodes)
- Upper rectal tumor (> 10 cm from anal margin)
- Pregnant, potentially pregnant, or breastfeeding women
- Persons deprived of liberty or under guardianship or unable to give consent
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The management of rectal cancers has changed over the past decades towards a multidisciplinary strategy, combining radiotherapy, chemotherapy, and surgery. Local recurrence rates, dropped to less than 6 % with pre-operative radiotherapy and the standardization of total mesorectal excision (TME), at the price of increased peri-operative morbidity and functional sequelae. Since neoadjuvant treatment achieves up to 30 % complete response, organ preservation has been increasingly debated for good responders. With the introduction of better-quality imaging for tumour visualization and treatment planning, a new targeted radiation treatment was introduced with high dose rate endorectal brachytherapy (HDRBT), developped by Dr Te Vuong's team in Montreal. This treatment allows for radiotherapy dose escalation to increase the complete response rate, and subsequently the rate of patients amenable to rectal preservation. This phase 2 trial study is proposed to assess the feasibility of HDR brachytherapy after standard chemoradiotherapy among patients selected for rectal preservation.
The group in the trial
- Endorectal brachytherapyTreatment being tested
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Endorectal Brachytherapy for Dose Escalation in Rectal Preservation Treatment of Rectal Cancer (ICUREC)
- Record updated
- 1 August 2025