The ctDNA-RECIST Trial Part One

NCT06562348 | Recruiting Phase 2

• 1 other identifier: KFE 2406
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 2

Brief Summary

A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.

Conditions

Gastrointestinal Neoplasm

Keywords

Circulating Tumor DNA; Liquid Biopsy; Gastrointestinal Neoplasm; Metastatic

Outcome Measures

Primary Outcomes (1)

• Compliance with protocol

  The fraction of participants in ARM B, who comply with the study procedures during the first 3 months after inclusion.

  3 months

Secondary Outcomes (3)

• Number of treatment cycles

  1 year

• Response rate Arm A

  1 year

• ctDNA response rate Arm B

  1 year

Study Arms (2)

A: Standard of care

ACTIVE COMPARATOR

Response evaluation using imaging-based RECIST according to standard guidelines.

Other: Standard of care

ctDNA-RECIST guided therapy approach

EXPERIMENTAL

Response evaluation will be performed using ctDNA-RECIST instead of imaging.

Other: ctDNA-RECIST guided palliative systemic treatment

Interventions

Standard of care OTHER

Patients will be offered palliative systemic treatment according to standard of care. Response evaluation will be performed with the imaging-based RECIST according to standard guidelines. Treatment pauses according to institutional guidelines. Blood samples will be analyzed retrospectively to evaluate ctDNA.

A: Standard of care

ctDNA-RECIST guided palliative systemic treatment OTHER

Patients are offered palliative systemic treatment according to standard of care. Response evaluation will be performed using ctDNA-RECIST. ctDNA is measured before start of treatment. If the baseline sample is ctDNA negative the patient is transferred to an observational cohort, and sampling procedures continues as in the standard arm. If the baseline sample is ctDNA positive the patient continues in the ctDNA-RECIST guided arm. Treatment response is evaluated according to ctDNA-RECIST, and further sampling follows a predefined decision schedule.

ctDNA-RECIST guided therapy approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incurable metastatic gastrointestinal cancer
• Indication for first or second-line systemic treatment
• Measurable disease according to RECIST v.1.1
• CT of chest and abdomen less than 30 days old at time of treatment initiation
• Age at least 18 years
• ECOG performance status 0-2
• Clinically eligible systemic palliative treatment at investigators decision.
• Adequate bone marrow, liver and renal function allowing systemic chemotherapy
• Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
• Written and verbally informed consent

You may not qualify if:

• Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
• Other concurrent malignant tumor except non-melanoma skin cancer or carcinoma in situ cervicis uteri
• Pregnant (positive pregnancy test) or breast-feeding women

Sponsors & Collaborators

• Karen-Lise Garm Spindler: lead
• Vejle Hospital: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Department pf Oncology, Vejle Hospital

Vejle, 7100, Denmark

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Neoplasm Metastasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Karen-Lise G Spindler, MD, Prof

  Department of Oncology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen-Lise G Spindler, MD, Prof

CONTACT

+4591167244; k.g.spindler@rm.dk

Torben F Hansen, MD, Prof

CONTACT

torben.hansen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: An open label 1:1 randomized phase II trial

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 20, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

DK (2)