Locally Advanced Rectal CarcinomaPhase 2ICURECNCT05591534
Endorectal Brachytherapy for Rectal Cancer
A Phase 2 study testing Endorectal brachytherapy in people with Locally Advanced Rectal Carcinoma, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Carcinoma
- What is being tested?
- Endorectal brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Jan 2024to Jan 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- 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)
- Metastatic disease
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- Contraindication to radiotherapy
- Unusual and unresolved rectal toxicity from external radiation therapy (> grade 1) at the time of inclusion
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Bordeaux, Service de Radiothérapie
Bordeaux
APHP - Hôpital Tenon, Service Oncologie-Radiothérapie
Paris
About this study
Official title: Endorectal Brachytherapy for Dose Escalation in Rectal Preservation Treatment of Rectal Cancer (ICUREC)
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.
Read the detailed description
The standard treatment for locally advanced rectal cancer consists in chemoradiotherapy followed by radical surgery with total mesorectal excision (TME) and adjuvant chemotherapy depending on lymph node status. This radiosurgical strategy has reduced local recurrence rates to less than 5% in expert centers, but at the cost of 20-30% morbidity and functional sequelae. Chemoradiotherapy can sterilize 15% of tumors, and up to 30% when neoadjuvant chemotherapy is given, calling into question the usefulness of systematic radical surgery in good responders. Ongoing trials are looking at treatment intensification either by chemotherapy intensification or by dose escalation in radiotherapy, with the aim of increasing the rectal preservation rate. Endorectal brachytherapy, developed by Prof. Té Vuong in Montreal, makes it possible to deliver a complementary dose directly to the tumor using a high-activity Iridium-192 radioactive source. It is an ambulatory treatment, which allows to deliver a complementary dose of 30 Gy in 3 sessions of 10 Gy at one week interval after external radiotherapy.
The objective of our trial is to demonstrate the feasibility of rectal brachytherapy for our patients in France with an acceptable toxicity rate similar to that described by the Canadian teams. In addition, this bicentric trial will allow to prove capacity to train radiotherapist colleagues in the technique of endorectal brachytherapy, which is an essential prerequisite for the development of the technique throughout France.
Main objective : To assess the feasibility of endorectal brachytherapy in patients showing partial response after standard neoadjuvant therapy with a goal of rectal preservation.
Secondary objectives: To describe the potential efficacy of endorectal brachytherapy in patients with partial response after standard neoadjuvant therapy by the complete clinical response rate and complete radiological response rate on MRI at 8 weeks, 4 months, 8 months, and 1 year, local recurrence rate, recurrence-free survival, and overall survival at 1 year Describe the rate of curative surgery (R0) in case of recurrence as well as the surgical morbidity according to the Dindo-Clavien score at 3 months after surgery.
- Conditions
- Locally Advanced Rectal Carcinoma
- Being tested
- Endorectal brachytherapy
- Keywords
- Endorectal brachytherapy, Rectal cancer, Radiotherapy, Non-operative management
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endorectal brachytherapyRadiation
Endorectal brachytherapy : 30 Gy in 3 sessions of 10 Gy delivered weekly
| Study group | Role | What they receive |
|---|---|---|
| Endorectal brachytherapy | Experimental | Endorectal brachytherapy Receives: Radiation: Endorectal brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
Proportion of patients receiving the 3 brachytherapy sessions without acute grade 3 proctitis (requiring hospitalization or transfusion) within 8 weeks after the end of treatment
Measured: 8 weeks after the end of treatment
Secondary outcomes (10)
Complete clinical response
Proportion of patients with a complete clinical response
Measured: At 8 weeks, 4 months, 8 months and 1 year
Complete radiological response
Proportion of patients with a complete radiological response on MRI
Measured: At 8 weeks, 4 months, 8 months and 1 year
Local recurrence
Proportion of patients with a local recurrence up to 1 year
Measured: At 1 year
Recurrence-free survival
Measured: At 1 year
Overall survival
Measured: At 1 year
Quality of life (EORTC QLQ C30)
The scores of questionnaire QLQ C-30 will be examined. The EORTC QLQ-C30 is a patients self-rating questionnaire that measures physical, role, social, emotional, and cognitive functions as well as overall QoL. Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales
Measured: At 8 weeks, 4 months, 8 months and 1 year
Quality of life (EORTC QLQ CR29)
The scores of questionnaire QLQ CR-29 will be examined. The EORTC QLQ-CR29 has five functional and 18 symptom scales. Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales
Measured: At 8 weeks, 4 months, 8 months and 1 year
Low Anterior Resection Syndrome score (LARS score)
The LARS questionnaire (low anterior resection score) evaluates bowel function. Five questions regarding incontinence for flatus and liquid stools, frequency, clustering and urgency for defecation are taken into account. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)
Measured: At 8 weeks, 4 months, 8 months and 1 year
Curative surgery for recurrence
Proportion of curative surgery in case of recurrence (R0)
Measured: Up to 1 year
Surgical morbidity for recurrence
Proportion of patients with and description of surgical morbidity (Dindo) at 3 months in case of surgery
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start31 Jan 2024
- Primary completionJul 2026 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: Unknown time frame for availability of new endorectal probes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique VENDRELY, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591534
- Sponsor's protocol ID
- CHUBX 2021/38
- Acronym
- ICUREC
- Status last verified
- Jul 2025
- First submitted
- 11 Oct 2022
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endorectal Brachytherapy for Dose Escalation in Rectal Preservation Treatment of Rectal Cancer (ICUREC)
- ClinicalTrials.gov ID
- NCT05591534
- Acronym / sponsor ID
- ICUREC / CHUBX 2021/38
- Conditions
- Locally Advanced Rectal Carcinoma
- Keywords
- Endorectal brachytherapy, Rectal cancer, Radiotherapy, Non-operative management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Unknown time frame for availability of new endorectal probes
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The standard treatment for locally advanced rectal cancer consists in chemoradiotherapy followed by radical surgery with total mesorectal excision (TME) and adjuvant chemotherapy depending on lymph node status. This radiosurgical strategy has reduced local recurrence rates to less than 5% in expert centers, but at the cost of 20-30% morbidity and functional sequelae. Chemoradiotherapy can sterilize 15% of tumors, and up to 30% when neoadjuvant chemotherapy is given, calling into question the usefulness of systematic radical surgery in good responders. Ongoing trials are looking at treatment intensification either by chemotherapy intensification or by dose escalation in radiotherapy, with the aim of increasing the rectal preservation rate. Endorectal brachytherapy, developed by Prof. Té Vuong in Montreal, makes it possible to deliver a complementary dose directly to the tumor using a high-activity Iridium-192 radioactive source. It is an ambulatory treatment, which allows to deliver a complementary dose of 30 Gy in 3 sessions of 10 Gy at one week interval after external radiotherapy.
The objective of our trial is to demonstrate the feasibility of rectal brachytherapy for our patients in France with an acceptable toxicity rate similar to that described by the Canadian teams. In addition, this bicentric trial will allow to prove capacity to train radiotherapist colleagues in the technique of endorectal brachytherapy, which is an essential prerequisite for the development of the technique throughout France.
Main objective : To assess the feasibility of endorectal brachytherapy in patients showing partial response after standard neoadjuvant therapy with a goal of rectal preservation.
Secondary objectives: To describe the potential efficacy of endorectal brachytherapy in patients with partial response after standard neoadjuvant therapy by the complete clinical response rate and complete radiological response rate on MRI at 8 weeks, 4 months, 8 months, and 1 year, local recurrence rate, recurrence-free survival, and overall survival at 1 year Describe the rate of curative surgery (R0) in case of recurrence as well as the surgical morbidity according to the Dindo-Clavien score at 3 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endorectal brachytherapy | Experimental | Radiation: Endorectal brachytherapyEndorectal brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endorectal brachytherapyEndorectal brachytherapy : 30 Gy in 3 sessions of 10 Gy delivered weekly | Radiation | Endorectal brachytherapy |
Primary outcome
Tolerance
Time frame: 8 weeks after the end of treatment
Proportion of patients receiving the 3 brachytherapy sessions without acute grade 3 proctitis (requiring hospitalization or transfusion) within 8 weeks after the end of treatment
10 secondary outcomes
Complete clinical response
Time frame: At 8 weeks, 4 months, 8 months and 1 year
Complete radiological response
Time frame: At 8 weeks, 4 months, 8 months and 1 year
Local recurrence
Time frame: At 1 year
Recurrence-free survival
Time frame: At 1 year
Overall survival
Time frame: At 1 year
Quality of life (EORTC QLQ C30)
Time frame: At 8 weeks, 4 months, 8 months and 1 year
Quality of life (EORTC QLQ CR29)
Time frame: At 8 weeks, 4 months, 8 months and 1 year
Low Anterior Resection Syndrome score (LARS score)
Time frame: At 8 weeks, 4 months, 8 months and 1 year
Curative surgery for recurrence
Time frame: Up to 1 year
Surgical morbidity for recurrence
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique VENDRELY principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endorectal brachytherapy in people with Locally Advanced Rectal Carcinoma, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance (time frame: 8 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.