Systemic Neoadjuvant and adjuvant Control by Precision medicine in rectal cancer (SYNCOPE) – approach on high-risk group to reduce metastases

Systemic Neoadjuvant and adjuvant Control by Precision medicine in rectal cancer (SYNCOPE) – approach on high-risk group to reduce metastases - SYNCOPE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003697-52-FI

Enrollment

Registered

2020-07-28

Start date

2020-09-16

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer MedDRA version: 20.0 Level: LLT Classification code 10038045 Term: Rectal cancer NOS System Organ Class: 100000004864

Interventions

Trade Name: Capesitabine Orion Pharmaceutical Form: Coated tablet INN or Proposed INN: kapesitabiini Other descriptive name: CAPECITABINE Trade Name: Capesitabine Orion Pharmaceutical Form: Coated ta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria are: rectal adenocarcinoma, proficient MMR status, DPYD genotype, WHO performance status 0-1, assessed by the MDT to undergo CAPOX (capecitabine and oxaliplatin) treatment AND assessed by the MDT to require either RT or CRT by the current standards. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 73

Exclusion criteria

Exclusion criteria: The exclusion criteria are: a contraindication to capecitabine, oxaliplatin or RT, or failing in blood tests that describe the adequate circulatory, liver and kidney function for chemotherapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Applying a systemic control with precision approach over the course of the rectal cancer therapy is logistically feasible. 2. Applying a systemic control and precision approach as a treatment strategy, recurrence-free survival of rectal cancer patients is improved. ;Secondary Objective: 3. Circulating tumor DNA is a reliable postoperative biomarker of minimal residual disease (MRD) for adjuvant chemotherapy decisions. 4. Chemosensitivity of patient-derived organoids (PDO) correlates to therapy response in prospective setting. ;Primary end point(s):	—

Measure

Time frame

Main Objective: 1. Applying a systemic control with precision approach over the course of the rectal cancer therapy is logistically feasible. 2. Applying a systemic control and precision approach as a treatment strategy, recurrence-free survival of rectal cancer patients is improved. ;Secondary Objective: 3. Circulating tumor DNA is a reliable postoperative biomarker of minimal residual disease (MRD) for adjuvant chemotherapy decisions. 4. Chemosensitivity of patient-derived organoids (PDO) correlates to therapy response in prospective setting. ;Primary end point(s):

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Countries

Finland

Contacts

Public ContactToni Seppälä

Helsinki University Hospital

toni.seppala@helsinki.fi+358504275580

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026