Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) (NCT05845450) | Clinical Trial Compass
RecruitingPhase 2
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Italy197 participantsStarted 2023-05-11
Plain-language summary
This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/combinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
General inclusion criteria
* Provide a signed and dated informed consent document.
* Age ≥ 18 years at time of informed consent.
* ECOG PS of 0 and 1.
* Histologically confirmed colorectal cancer adenocarcinoma that is judged as initially resectable with elective surgery aimed at radical intent with R0 margins as per multidisciplinary team assessment.
* Radiological stage cT3-4, N0-2, M0 using computed tomography (CT) as in the pivotal FOxTROT study.
* Patients with rectal cancer candidate for R0 resection, not requiring pre-operative radiotherapy based on multidisciplinary team assessment, with the following characteristics on high-resolution thin slice (3 mm) contrast-enhanced magnetic resonance imaging (MRI):
* ≤ T3a defined at the MRI (perivisceral fat infiltration \<2 mm) and clinical N0
* Upper-medium, defined as tumors with distal margin ≥ 5 cm from the anal verge.
* Absence of mesorectal fascia invasion, as defined as a distance ≥ 1 mm between tumor and the mesorectal fascia.
* Able to provide enough archival FFPE tumor specimen that is already available from initial diagnostic procedures for the purpose of molecular pre-screening.
* Presence of one of the selected molecular profile/alteration after central pre-screening and necessary for the assignment to a matching treatment cohort.
* No prior systemic treatment for colorectal cancer or neoadjuvant radiation therapy for rectal cancer.
* Adequate bone marrow function (absolute neutrophil …