Targeted radiation treatment for rectal cancer
Endorectal Brachytherapy for Dose Escalation in Rectal Preservation Treatment of Rectal Cancer (ICUREC)
PHASE2 · University Hospital, Bordeaux · NCT05591534
This study is testing a new type of targeted radiation treatment for patients with advanced rectal cancer to see if it can help shrink tumors and avoid the need for major surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Bordeaux and 1 other locations) |
| Trial ID | NCT05591534 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial evaluates the feasibility of high dose rate endorectal brachytherapy (HDRBT) for patients with locally advanced rectal carcinoma. The approach involves delivering a targeted radiation dose directly to the tumor after external beam radiotherapy, aiming to increase the rate of complete tumor response and enable organ preservation. The study will assess the treatment's safety and effectiveness, as well as train radiotherapists in this innovative technique. Conducted at two centers in France, the trial seeks to provide a less invasive alternative to radical surgery.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed rectal adenocarcinoma that meets specific tumor size and staging criteria.
Not a fit: Patients with advanced metastatic disease or those who do not respond to initial external beam radiotherapy may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the preservation of rectal function and reduce the need for radical surgery in patients with rectal cancer.
How similar studies have performed: Other studies have shown promising results with similar targeted radiation approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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
Where this trial is running
Bordeaux and 1 other locations
- CHU de Bordeaux, Service de Radiothérapie — Bordeaux, France (RECRUITING)
- APHP - Hôpital Tenon, Service Oncologie-Radiothérapie — Paris, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Véronique VENDRELY — University Hospital, Bordeaux
- Study coordinator: Véronique VENDRELY
- Email: veronique.vendrely@chu-bordeaux.fr
- Phone: 05 57 62 33 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced Rectal Carcinoma, Endorectal brachytherapy, Rectal cancer, Radiotherapy, Non-operative management