Magnetic Resonance Imaging (MRI)-Guided Rectal Cancer Preservation Program

ConditionRectal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorClinica Universidad de Navarra, Universidad de Navarra

About this trial

The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of rectal preservation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 or older with primary Stage II (T3-4, N0) or Stage III (any T, N1-2) biopsy-proven rectal cancer

No prior radiation therapy to the target areas;

Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3

Platelets ≥ 50,000 cells/mm3.

Disqualifiers

Patient unable to undergo an MRI examination

Trial design

Design model

Single group

Treatments tested in this trial

  • MR-Guided Irradiation

    Radiation

    MR-Guided Irradiation

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Dose Escalation PhaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total Mesorectal Excision (TME)-free survival

To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.

Time frame
5-years

Secondary outcomes

1

Proctitis/Rectal Bleeding

To achieve a CTCAE v5 grade 2-3 proctitis of less than 10% and grade 2-3 rectal bleeding rate of \<2% at 2 years.

Time frame
5-years
2

Fecal Continence

To achieve a Wexner Continence score of at least 90% over baseline at 2 years.

Time frame
5-years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: