The ctDNA-RECIST Trial Part One

Last updated: April 29, 2025
Sponsor: Karen-Lise Garm Spindler
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Stomach Cancer

Gastrointestinal Diseases And Disorders

Treatment

Standard of care

ctDNA-RECIST guided palliative systemic treatment

Clinical Study ID

NCT06562348
KFE 2406
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 hormonalcontraceptive are acceptable

  • Written and verbally informed consent

Exclusion

Exclusion Criteria:

  • Incapacity, frailty, disability and comorbidity to a degree that according to theinvestigator is not compatible with combination chemotherapy

  • Other concurrent malignant tumor except non-melanoma skin cancer or carcinoma insitu cervicis uteri

  • Pregnant (positive pregnancy test) or breast-feeding women

Study Design

Total Participants: 167
Treatment Group(s): 2
Primary Treatment: Standard of care
Phase: 2
Study Start date:
January 15, 2025
Estimated Completion Date:
September 01, 2030

Study Description

Background:

Circulating tumor DNA, (ctDNA) has the potential to better monitor treatment efficacy compared to imaging, possibly sparing the patient for ineffective treatment and their associated toxicity an allowing for an early change of the treatment approach.

Based on multiple dataset we have defined ctDNA-RECIST - the ctDNA response evaluation criteria.

Aim: This phase II randomized trial evaluates the use of ctDNA Response Evaluation Criteria in Solid Tumors (ctDNA-RECIST) versus standard imaging-based RECIST to guide treatment decisions in patients with metastatic gastrointestinal cancers.

Design: Patients are randomized 1:1. Patients in Arm A are offered standard treatment with response evaluation according to the RECIST criteria based on imaging, and treatment pauses according to institutional guidelines.

In Arm B, treatment response is evaluated based on change in ctDNA between the baseline sample and the evaluation and confirmation sample, according to ctDNA-RECIST:

  • Progressive disease: An increase of ctDNA above the previous value with no overlap of the two CI's

  • Stable disease: A value within CI of the previous value. The category also includes samples with both previous and present value being 0 (undetectable).

  • Partial Response: A decrease below the previous value with no overlap of the two CI'S but the lower CI does not overlap 0.

  • Complete response: Decreasing value to an undetectable level

  • Near complete response: A decrease below the previous value with no overlap of the two CI'S and with the lower CI overlapping 0

Complete and near complete response can be combined and classified as maximal response.

The study is initiated as a feasibility study (part one)and will continue into the expansion trial after interim analysis.(part two)

Connect with a study center

  • Aarhus University Hospital

    Aarhus, 8000
    Denmark

    Active - Recruiting

  • Department pf Oncology, Vejle Hospital

    Vejle, 7100
    Denmark

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.