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

NCT07616297 | Recruiting

• 1 other identifier: NL-010517
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer; Radiation Oncology

Keywords

Radiation Oncology; Rectal cancer; Organ Preservation

Outcome Measures

Primary Outcomes (1)

• Organ preservation

  Organ preservation is considered unsuccessful if the rectum is surgically removed, a stoma is present, or a non-salvageable locoregional cancer recurrence is developed.

  During two-year follow-up

Secondary Outcomes (13)

• Rate of clinical complete response

  Assessed at the two response assessments (14-16 weeks and 26 weeks after the start of treatment)

• Rate of pathological complete response

  During two-year follow-up

• Local progression-free survival

  During two-year follow-up

• Distant progression-free survival

  During three-year follow-up

• Overall survival

  During three-year follow-up

Study Arms (1)

Simultaneous integrated boost

EXPERIMENTAL

Treatment arm, in which all participating patients will receive the simultaneous integrated boost (SIB)

Radiation: Simultaneous integrated boost to the tumor and positive mesorectal lymph nodes

Interventions

Simultaneous integrated boost to the tumor and positive mesorectal lymph nodes RADIATION

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.

Simultaneous integrated boost

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Previous radiotherapy in the pelvic area
• 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

Sponsors & Collaborators

• Claudia Schuurhuizen: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: June 1, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)