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

Sponsor
Claudia Schuurhuizen
Study ID
NCT07616297
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Jan 27, 2026
Status verified
May 2026
Primary completion
Aug 1, 2029
Completion
Aug 1, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Organ preservation [ Time Frame: During two-year follow-up ]

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