Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total neoadjuvant therapy (TNT), Minimal residual disease (MRD), Long radiation therapy.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer (SYNCOPE) - Approach on High-risk Group to Reduce Metastases
Overview
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.
Interventions
- Drug Total neoadjuvant therapy (TNT)
Short radiotherapy (5X5 Gy) and capecitabine/oxaliplatin - Diagnostic test Minimal residual disease (MRD)
Postoperative MRD on circulating cell-free DNA - Radiation Long radiation therapy
Long-course 50.4 Gy radiation with capecitabine
Primary outcome measures
- Recurrence-free survival [Time frame: 3 years from surgery]
- Recurrence-free survival [Time frame: 5 years from surgery]
- Postoperative ctDNA [Time frame: 3 weeks postoperatively]
Secondary outcome measures (12)
- CRC-specific survival [Time frame: 3 years]
- CRC-specific survival [Time frame: 5 years]
- overall survival [Time frame: 3 years]
- overall survival [Time frame: 5 years]
- number of surgically resected patients resected patients [Time frame: 1 year]
- R0-resection rate [Time frame: 1 year]
- local recurrence rate [Time frame: 5 years postoperatively]
- complete pathological response response rate [Time frame: 12 weeks after initiation of pretreatment]
- complete clinical response rate [Time frame: 12 weeks after initiation of pretreatment]
- total uptake of chemotherapy [Time frame: 1year]
- total uptake of chemotherapy [Time frame: 3 years]
- total uptake of chemotherapy [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- rectal adenocarcinoma,
- 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
- deficient mismatch repair (MMR) status,
- non-dihydropyrimidine dehydrogenase (DPYD) genotype,
- a contraindication to capecitabine, oxaliplatin or RT, or
- failing in blood tests that describe the adequate circulatory, liver and kidney function for chemotherapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 2 centers
- Helsinki University Central Hospital — Helsinki
- Tampere University Hospital — Tampere
Identifiers
NCT: NCT04842006 · HUS/155/2021