NCT04842006: SYNCOPE

Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer

Recruiting now NA Last updated 6 March 2023

What this trial tests

NA trial testing Total neoadjuvant therapy (TNT) in Colorectal Cancer in 93 participants. Currently enrolling.

Timeline

20 December 2021

Primary endpoint
31 August 2028

31 December 2031

Quick facts

Lead sponsor	Helsinki University Central Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	93
Start date	20 December 2021
Primary completion	31 August 2028
Estimated completion	31 December 2031
Sites	2 locations across Finland

Drugs / interventions tested

• Total neoadjuvant therapy (TNT) — full drug profile →
• Minimal residual disease (MRD)
• Long radiation therapy

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Helsinki University Central Hospital

Who can join

Adults 18 to 100, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 be compared to conventional treatment. The study aims to reduce over-treatment of those that most likely do not benefit from additional treatments. With the overall aim to reduce metastatic form of the disease, patients with high-risk features will be randomized to a treatment strategy with early systemic control by chemotherapy followed by circulating tumor DNA (ctDNA) and organoid-guided adjuvant therapy, or to conventional treatment strategy. Both state-of-the-art laboratory practice and routine diagnostic clinical pipelines are introduced to bring future diagnostic models of minimal residual disease and chemoresistance closer to current practice. The outcomes will reveal the clinical benefit of such strategy by recurrence-free survival at highest level of evidence, and produce important clinical outcome data on the application of ctDNA in everyday cancer treatment practice. The translational data on the use of ctDNA organoids to inform treatment decision and regimen selection will build knowledge of the use of such biomarkers as tools for clinical practice and clinical research. The results will be scalable worldwide in the practice of rectal cancer treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Functional precision oncology: Testing tumors with drugs to identify vulnerabilities and novel combinations.
   Letai A, Bhola P, Welm AL. · · 2022 · cited 182× · PMID 34951956 · DOI 10.1016/j.ccell.2021.12.004
2. Patient-derived tumor organoids: a new avenue for preclinical research and precision medicine in oncology.
   Thorel L, Perréard M, Florent R, Divoux J, et al · · 2024 · cited 90× · PMID 38945959 · DOI 10.1038/s12276-024-01272-5
3. Liquid biopsies to monitor and direct cancer treatment in colorectal cancer.
   Mauri G, Vitiello PP, Sogari A, Crisafulli G, et al · · 2022 · cited 79× · PMID 35264786 · DOI 10.1038/s41416-022-01769-8
4. Applications of human organoids in the personalized treatment for digestive diseases.
   Wang Q, Guo F, Jin Y, Ma Y. · · 2022 · cited 43× · PMID 36167824 · DOI 10.1038/s41392-022-01194-6
5. Organoids: development and applications in disease models, drug discovery, precision medicine, and regenerative medicine.
   Yao Q, Cheng S, Pan Q, Yu J, et al · · 2024 · cited 40× · PMID 39309690 · DOI 10.1002/mco2.735
6. Liquid biopsy into the clinics: Current evidence and future perspectives.
   Boukovala M, Westphalen CB, Probst V. · · 2024 · cited 29× · PMID 40027149 · DOI 10.1016/j.jlb.2024.100146
7. Circulating tumour DNA as biomarker for rectal cancer: A systematic review and meta-analyses.
   van Rees JM, Wullaert L, Grüter AAJ, Derraze Y, et al · · 2023 · cited 18× · PMID 36793616 · DOI 10.3389/fonc.2023.1083285
8. The Position of Circulating Tumor DNA in the Clinical Management of Colorectal Cancer.
   de Abreu AR, Op de Beeck K, Laurent-Puig P, Taly V, et al · · 2023 · cited 14× · PMID 36831626 · DOI 10.3390/cancers15041284