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Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer (SYNCOPE)

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ClinicalTrials.gov Identifier: NCT04842006
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Toni Seppala, Helsinki University Central Hospital

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Total neoadjuvant therapy (TNT) Diagnostic Test: Minimal residual disease (MRD) Radiation: Long radiation therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer (SYNCOPE) - Approach on High-risk Group to Reduce Metastases
Actual Study Start Date : December 20, 2021
Estimated Primary Completion Date : August 31, 2028
Estimated Study Completion Date : December 31, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arms and Interventions
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Arm Intervention/treatment
Experimental: TNT + precision 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
Active Comparator: Conventional Radiation: Long radiation therapy
Long-course 50.4 Gy radiation with capecitabine


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: 3 years from surgery ]
  2. Recurrence-free survival [ Time Frame: 5 years from surgery ]
  3. 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


Secondary Outcome Measures :
  1. CRC-specific survival [ Time Frame: 3 years ]
  2. CRC-specific survival [ Time Frame: 5 years ]
  3. overall survival [ Time Frame: 3 years ]
  4. overall survival [ Time Frame: 5 years ]
  5. number of surgically resected patients resected patients [ Time Frame: 1 year ]
  6. R0-resection rate [ Time Frame: 1 year ]
  7. local recurrence rate [ Time Frame: 5 years postoperatively ]
  8. complete pathological response response rate [ Time Frame: 12 weeks after initiation of pretreatment ]
  9. complete clinical response rate [ Time Frame: 12 weeks after initiation of pretreatment ]
  10. total uptake of chemotherapy [ Time Frame: 1year ]
  11. total uptake of chemotherapy [ Time Frame: 3 years ]
  12. total uptake of chemotherapy [ Time Frame: 5 years ]
  13. adverse effects of surgery effects of surgery [ Time Frame: 1 year ]
  14. adverse effects of chemotherapy [ Time Frame: 1 year ]
  15. adverse effects of chemotherapy [ Time Frame: 3 years ]
  16. Treatment response by patient-derived organoid (PDO) therapy response [ Time Frame: 1 year ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842006


Contacts
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Contact: Toni T Seppala, MD, PhD 14108149966 toni.t.seppala@hus.fi

Locations
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Finland
Helsinki University Central Hospital Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Toni T Seppala, MD, PhD    +358504270637    toni.t.seppala@hus.fi   
Tampere University Hospital Not yet recruiting
Tampere, Finland, 33520
Contact: Toni Seppala, Prof         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Toni T Seppala, MD, PhD Helsinki University Central Hospital
More Information
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Responsible Party: Toni Seppala, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04842006    
Other Study ID Numbers: HUS/155/2021
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases