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Clinical Trials in the Netherlands / NCT07616297
Recruiting Not applicable

Higher Radiation Dose to the Tumor May Help Avoid Surgery in Rectal Cancer Patients

NCT07616297 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Claudia Schuurhuizen
Phase
Not applicable
Started
2026-01-27
Last updated
2026-06-01

Condition(s) studied

Rectal CancerRadiation Oncology

Investigational drug(s) / intervention(s)

Simultaneous integrated boost to the tumor and positive mesorectal lymph nodes

Simultaneous integrated boost to the tumor and positive mesorectal lymph nodes: Addition of a simultaneous integrated boost (SIB) to the standard chemoradiotherapy (CRT) scheme of 2.0 Gy to the mesorectum. The radiotherapy scheme consists of 25 fractions, delivering 2.0 Gy per fraction to the mesorectum and 2.4 Gy per fraction to the tumor and positive mesorectal lymph nodes.

Study summary

The goal of this prospective study is to evaluate if a higher radiation dose to the tumor can increase the organ preservation rate in non-locally advanced rectal cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years * Eastern cooperative oncology group (ECOG) performance status ≤2 * Histologically confirmed rectal adenocarcinoma * Non-locally advanced rectal cancer, defined as (magnetic resonance imaging (MRI)-based) T1-3, N0/N1 (≤3 positive mesorectal lymph nodes), MX/M0 * Indication for curative treatment with organ preservation * Discussed in the multidisciplinary tumor board (MTB) * Written informed consent Exclusion Criteria: * Previous radiotherapy in the pelvic area * Other malignancies, except for adequately treated basal cell carcinoma (BCC), at time of inclusion or within 3 years prior to inclusion * Contra-indications for (chemo)radiotherapy or surgery * Presence of lateral lymph nodes, cN2 status, extramural vascular invasion (EMVI) or mesorectal fascia involvement as seen on MRI * Mucinous defined tumor on MRI * Prior local excision of the primary tumor * DPD (dihydropyrimidine dehydrogenase) deficiency * Unable to understand the requirements of the study and to give written informed consent, as determined by the treating physician

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Erasmus MC Rotterdam South Holland Recruiting

Other trials for the same condition

Feasibility of the Maastro Applicator in Rectal Cancer Active, not recruiting
Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision Recruiting
Registry Maastro Applicator Recruiting
DETECT: Target Volume for Rectal Endoluminal Radiation Boosting Recruiting
Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesions Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07616297 on ClinicalTrials.gov ↗ ← All trials in the Netherlands