Higher radiation dose to the tumor to avoid surgery in rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-randomized, single-arm, phase II study at a single center evaluating an online adaptive CBCT-based boost to the tumor and involved lymph nodes. The trial will measure organ preservation rates at two years, along with response, recurrence, survival, toxicities, bowel function, and quality of life. It uses a cone-beam CT workflow to deliver a boosted radiation dose intended to improve tumor control while preserving the organ. Enrolled adults with non-locally advanced rectal cancer who desire organ preservation will receive the intervention and be followed prospectively. The study will also assess treatment feasibility, motion management, and biological effects related to the boost strategy.

Why it matters

Who can join: the full rules

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

Where it's running

• Erasmus MC
  Rotterdam, South Holland, Netherlands Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.