CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 168 target
Drug / intervention
Contact x-ray brachytherapy +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically verified adenocarcinoma above dentate line and within 10cm of anal verge
  • ✓Short-course radiotherapy with delayed response evaluation for IRC or LARC with comorbidity/frailty
  • ✓Long-course radiotherapy/chemoradiation for LARC per guidelines or early/IRC with organ preservation desire
  • ✓Clinically near-complete response or small residual tumor mass <3 cm
Key exclusion· 6
  • ✕Neoadjuvant or induction chemotherapy prior or adjacent to (chemo)radiation (e.g., Rapido or M1-scheme)
  • ✕Radiation dose >50.4 Gy or boost dose on primary tumor
  • ✕Suspicious lymph nodes (yN1/N2) at first response evaluation
  • ✕Residual tumor ≥3 cm or over half circumference of rectal lumen

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05772923
NCT05772923N/ARecruitingUpdate OverdueUpdated 39mo ago · Completion was 16mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

Organ Preservation in Patients With a Good Clinical Response After (Chemo)Radiation for Rectal Cancer: Defining the Role of Additional Contact X-ray Brachytherapy Versus Extending the Waiting Interval and Local Excision

The Netherlands Cancer Institute·interventional·Posted Mar 17, 2023·Updated Mar 17, 2023

In Brief

A clinical study evaluating Contact x-ray brachytherapy and Local excision for Organ Preservation and 3 related conditions. Currently recruiting, targeting 168 participants across 7 sites.

Signals

Enrollment appears stalled

Detailed Summary

The goal of this prospective phase II feasibility study is to evaluate two additional local treatment options in rectal cancer patients with a good clinical response after neoadjuvant (chemo)radiation: contact x-ray brachytherapy versus extension of the waiting interval with or without local excision, and to investigate which rate of organ preservation can be achieved.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOrgan Preservation, Rectal Cancer, Quality of Life, Locally Advanced Rectal Carcinoma
CountriesNetherlands
CollaboratorsCatharina Ziekenhuis Eindhoven, ZonMw: The Netherlands Organisation for Health Research and Development

Timeline

N/ARecruiting
20222023202420252026202720282029
First PostedMar 17, 2023
Enrollment StartApr 16, 2021
Primary CompletionMar 1, 2025
Study CompletionMar 1, 2029
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 3.3 years ago

Interventions

Contact x-ray brachytherapyradiation

With contact x-ray brachytherapy an intraluminal radiation boost up to 90 Gy is applied to the primary rectal tumour, with minimal collateral damage to the surrounding normal tissues due to minimal penetration of the 50 kVolt therapy.

Local excisionprocedure

Local excision will basically be performed by the TAMIS-procedure (transanal minimally invasive surgery).