Colorectal CancerSYNCOPENCT04842006
Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer
A study testing Total neoadjuvant therapy (TNT), Minimal residual disease (MRD) and Long radiation therapy in people with Colorectal Cancer, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Total neoadjuvant therapy (TNT), Minimal residual disease (MRD) and Long radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesFinland
- Study dates
- 20 Dec 2021to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki, Uusimaa, 00029
Toni T Seppala, MD, PhD, +358444722846, toni.t.seppala@hus.fi
- Recruiting
Tampere University Hospital
Tampere, 33520
Toni Seppala, Prof, +358444722846, toni.seppala@pirha.fi
About this study
Official title: Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer (SYNCOPE) - Approach on High-risk Group to Reduce Metastases
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.
- Conditions
- Colorectal Cancer
- Being tested
- Total neoadjuvant therapy (TNT), Minimal residual disease (MRD), Long radiation therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total neoadjuvant therapy (TNT)Drug
Short radiotherapy (5X5 Gy) and capecitabine/oxaliplatin
Minimal residual disease (MRD)Diagnostic test
Postoperative MRD on circulating cell-free DNA
Long radiation therapyRadiation
Long-course 50.4 Gy radiation with capecitabine
| Study group | Role | What they receive |
|---|---|---|
| TNT + precision | Experimental | Not described Receives: Drug: Total neoadjuvant therapy (TNT); Diagnostic Test: Minimal residual disease (MRD) |
| Conventional | Active comparator | Not described Receives: Radiation: Long radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Measured: 3 years from surgery
Recurrence-free survival
Measured: 5 years from surgery
Postoperative ctDNA
number of patients with detectable ctDNA at postoperative sample in the conventional treatment arm that are not assigned to chemotherapy
Measured: 3 weeks postoperatively
Secondary outcomes (16)
CRC-specific survival
Measured: 3 years
CRC-specific survival
Measured: 5 years
overall survival
Measured: 3 years
overall survival
Measured: 5 years
number of surgically resected patients resected patients
Measured: 1 year
R0-resection rate
Measured: 1 year
local recurrence rate
Measured: 5 years postoperatively
complete pathological response response rate
Measured: 12 weeks after initiation of pretreatment
complete clinical response rate
Measured: 12 weeks after initiation of pretreatment
total uptake of chemotherapy
Measured: 1year
total uptake of chemotherapy
Measured: 3 years
total uptake of chemotherapy
Measured: 5 years
adverse effects of surgery effects of surgery
Measured: 1 year
adverse effects of chemotherapy
Measured: 1 year
adverse effects of chemotherapy
Measured: 3 years
Treatment response by patient-derived organoid (PDO) therapy response
population distribution of PDO treatment response is compared to their corresponding clinical response by response MRI and pathological response and compared to organoid in vitro response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start20 Dec 2021
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toni Seppala, Helsinki University Central Hospital
- Investigators
- Toni T Seppala, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842006
- Sponsor's protocol ID
- HUS/155/2021
- Acronym
- SYNCOPE
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer (SYNCOPE) - Approach on High-risk Group to Reduce Metastases
- ClinicalTrials.gov ID
- NCT04842006
- Acronym / sponsor ID
- SYNCOPE / HUS/155/2021
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNT + precision | Experimental | Drug: Total neoadjuvant therapy (TNT), Diagnostic Test: Minimal residual disease (MRD) |
| Conventional | Active comparator | Radiation: Long radiation therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total neoadjuvant therapy (TNT)Short radiotherapy (5X5 Gy) and capecitabine/oxaliplatin | Drug | TNT + precision |
| Minimal residual disease (MRD)Postoperative MRD on circulating cell-free DNA | Diagnostic test | TNT + precision |
| Long radiation therapyLong-course 50.4 Gy radiation with capecitabine | Radiation | Conventional |
Primary outcome
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
number of patients with detectable ctDNA at postoperative sample in the conventional treatment arm that are not assigned to chemotherapy
16 secondary outcomes
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
adverse effects of surgery effects of surgery
Time frame: 1 year
adverse effects of chemotherapy
Time frame: 1 year
adverse effects of chemotherapy
Time frame: 3 years
Treatment response by patient-derived organoid (PDO) therapy response
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Toni T Seppala, MD, PhD principal investigator
Tampere University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total neoadjuvant therapy (TNT), Minimal residual disease (MRD) and Long radiation therapy in people with Colorectal Cancer, run by Helsinki University Central Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toni T Seppala, MD, PhD (+358444722846, toni.seppala@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: 3 years from surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.