Radiotherapy dose escalation for unresectable locally recurrent 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

The trial explores radiotherapy dose escalation as part of non-operative management for unresectable locally recurrent rectal cancer. It uses two feasible approaches: SBRT reirradiation or hyperfractionated chemo-reirradiation in previously irradiated patients, and full-course chemoradiotherapy with a simultaneous integrated boost in radiotherapy-naïve patients. Feasibility is defined by limited acute high-grade toxicities, with secondary goals including symptom control, quality of life, and local control. The study enrolls adults with unresectable disease, determined by MDT consensus, and excludes those with overt distant metastases requiring immediate systemic therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years old.
* Diagnosis of locally recurrent rectal cancer, defined as recurrent disease within the pelvis after surgical excision for primary rectal or distal sigmoidal cancer, diagnosed either by histopathology or clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT). A second recurrence is eligible if (chemo-)reirradiation is considered feasible, with consensus in MDT.
* Recurrent disease is determined as unresectable where surgery has been ruled out by clinicians (or refused by patient), with consensus in MDT.

Unresectable is defined as: expected gross incomplete resection with overt tumour remaining in the patient after resection, encasement of the ischiadic nerve and invasion of the cortex and/or neuroforamina from S2 and upwards.

\- Either radiological absence of distant metastatic disease (M0), or, with (oligo)metastatic disease that does not require imminent start of systematic therapy at time of inclusion.

If systematic chemotherapy was previously administered prior to inclusion, and there is a current indication for local treatment with radiotherapy, patients are still eligible.

* WHO/ECOG performance score 0-2.
* MR pelvis and thoracoabdominal CT with interpretation no longer than 6 weeks prior to inclusion.
* Written informed consent according to the ICH-GCP and national/local regulations.

Exclusion Criteria:

* Radiological evidence of extensive metastatic disease (e.g., extensive liver or lung metastases) at time of inclusion, that requires imminent start of systemic therapy, with consensus in MDT.
* Radiotherapy in the past 6 months.
* Any contraindication for planned radiotherapy dose escalation, as determined by the radiation oncologist (e.g., residual grade 3 toxicity from previous radiotherapy).
* Administration of bevacizumab/panitumumab/cetuximab \<6 weeks prior to start radiotherapy dose escalation.
* Severe active morbidity, concomitant disease or active infections.
* dMMR/MSI status

Where it's running

• Radiotherapiegroep
  Arnhem, Netherlands Recruiting
• Rijnstate
  Arnhem, Netherlands Recruiting
• Catharina Hospital
  Eindhoven, Netherlands Recruiting
• University Medical Centre Utrecht
  Utrecht, Netherlands Recruiting
• MAASTRO Clinic
  Maastricht, Limburg, Netherlands Not yet recruiting
• Erasmus Medical Centre
  Rotterdam, Netherlands Not yet recruiting

Study contacts

• Principal investigator: H.M.U. Peulen, MD, PhD — Catharina Hospital, Department of Radiation Oncology
• Study coordinator: H.M.U. Peulen, MD, PhD
• Email: heike.peulen@catharinaziekenhuis.nl
• Phone: 040 - 239 64 00

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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.