Locally Advanced Rectal Carcinoma Clinical Trial
— ICURECOfficial 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.
Status | Recruiting |
Enrollment | 31 |
Est. completion date | January 2026 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux, Service de Radiothérapie | Bordeaux | |
France | APHP - Hôpital Tenon, Service Oncologie-Radiothérapie | Paris |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 8 weeks after the end of treatment | |
Secondary | Complete clinical response | Proportion of patients with a complete clinical response | At 8 weeks, 4 months, 8 months and 1 year | |
Secondary | Complete radiological response | Proportion of patients with a complete radiological response on MRI | At 8 weeks, 4 months, 8 months and 1 year | |
Secondary | Local recurrence | Proportion of patients with a local recurrence up to 1 year | At 1 year | |
Secondary | Recurrence-free survival | At 1 year | ||
Secondary | Overall survival | At 1 year | ||
Secondary | 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 | At 8 weeks, 4 months, 8 months and 1 year | |
Secondary | 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 | At 8 weeks, 4 months, 8 months and 1 year | |
Secondary | 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) | At 8 weeks, 4 months, 8 months and 1 year | |
Secondary | Curative surgery for recurrence | Proportion of curative surgery in case of recurrence (R0) | Up to 1 year | |
Secondary | Surgical morbidity for recurrence | Proportion of patients with and description of surgical morbidity (Dindo) at 3 months in case of surgery | 3 months after surgery |
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