Precision medicine approach for treating rectal cancer
Official title: Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer (SYNCOPE) - Approach on High-risk Group to Reduce Metastases
Run by Helsinki University Central Hospital · NCT04842006 · Data updated 2026-11-12
This study is testing a new personalized approach to treat rectal cancer to see if it works better than standard treatments in helping patients get the best care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 93 (estimated) |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Helsinki, Uusimaa and 1 other locations) |
| Status | Recruiting |
| Started | December 20, 2021 |
| Main results expected | August 31, 2028 |
| Study ends | December 31, 2031 |
| Registry record updated | March 6, 2023 |
| Trial ID | NCT04842006 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with rectal adenocarcinoma who have a WHO performance status of 0-1 and require radiotherapy or long chemoradiotherapy.
✕Probably not a fit
Patients with deficient mismatch repair status or contraindications to the required treatments will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial focuses on improving treatment outcomes for patients with rectal cancer by utilizing precision medicine techniques. It aims to compare the effectiveness of novel precision methods against conventional treatment approaches in selecting the appropriate therapy for patients. The study will involve total neoadjuvant therapy, minimal residual disease assessment, and long radiation therapy to optimize treatment decisions. By characterizing the primary tumor status before surgery, the trial seeks to reduce the risk of over-treatment and improve patient outcomes.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for rectal cancer patients, potentially improving survival rates.
How similar studies have gone: Other studies utilizing precision medicine in cancer treatment have shown promising results, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland Recruiting -
Tampere University Hospital
Tampere, Finland Recruiting
Study contacts
- Principal investigator: Toni T Seppala, MD, PhD — Tampere University Hospital
- Study coordinator: Toni T Seppala, MD, PhD
- Email: toni.seppala@tuni.fi
- Phone: +358444722846
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.