Endorectal Brachytherapy for Rectal Cancer

NCT05591534 | Suspended Phase 2 DMC

• 1 other identifier: CHUBX 2021/38
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Locally Advanced Rectal Carcinoma

Keywords

Endorectal brachytherapy; Rectal cancer; Radiotherapy; Non-operative management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Complete clinical response

  At 8 weeks, 4 months, 8 months and 1 year

• Complete radiological response

  At 8 weeks, 4 months, 8 months and 1 year

• Local recurrence

  At 1 year

• Recurrence-free survival

  At 1 year

• Overall survival

  At 1 year

Study Arms (1)

Endorectal brachytherapy

EXPERIMENTAL

Endorectal brachytherapy

Radiation: Endorectal brachytherapy

Interventions

Endorectal brachytherapy RADIATION

Endorectal brachytherapy : 30 Gy in 3 sessions of 10 Gy delivered weekly

Endorectal brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

CHU de Bordeaux, Service de Radiothérapie

Bordeaux, France

Location

APHP - Hôpital Tenon, Service Oncologie-Radiothérapie

Paris, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Véronique VENDRELY

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 24, 2022
• Study Start: January 31, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)