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Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer

RecruitingNAAges 18 Years - 100 YearsAllHelsinki University Central Hospital
NCT04842006 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rectal cancer represents the most complex area of multidisciplinary treatment in bowel surgery. In 2017, there were 1221 new rectal cancers in Finland. The prognosis of colorectal cancer (CRC) patients these days is almost exclusively driven by the occurrence of the metastatic form of the disease. The treatment of rectal cancer often includes a long delay between diagnosis and the initiation of systemic chemotherapy, increasing risk for systemic metastases for those at high risk. On the other hand, the waiting time during pretreatment before surgery enables comprehensive systematic characterization of the primary tumor status before the decisions on adjuvant chemotherapy, opening a window to the use of precision in decision-making. In this randomized controlled treatment trial, outcomes of novel precision methods to select right rectal cancer patients for treatment that they need will

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. rectal adenocarcinoma, 2. World Health Organization (WHO) performance status 0-1, assessed by the MDT to be able to undergo capecitabine and oxaliplatin (CAPOX) treatment, 3) extramural vein invasion by magnetic resonance imaging (mrEMVI+) and 4\) assessed by the multi-disciplinary team (MDT) to require either radiotherapy (RT) or long chemoradiotherapy (CRT) by the current standards. Exclusion Criteria: 1. deficient mismatch repair (MMR) status, 2. non-dihydropyrimidine dehydrogenase (DPYD) genotype, 3. a contraindication to capecitabine, oxaliplatin or RT, or 4. failing in blood tests that describe the adequate circulatory, liver and kidney function for chemotherapy.
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What it tests

  • Total neoadjuvant therapy (TNT)
  • Minimal residual disease (MRD)
  • Long radiation therapy
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Where

2 sites
Helsinki University Central Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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