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Recruiting NCT06562348

The ctDNA-RECIST Trial Part One

Phase II Interventional Gastrointestinal Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of care, ctDNA-RECIST guided palliative systemic treatment.
Who it may be relevant to
Registry conditions: Gastrointestinal Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial

Overview

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

Detailed 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)

Interventions

  • Other Standard of care
    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.
  • Other ctDNA-RECIST guided palliative systemic treatment
    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 fu

Primary outcome measures

  • Compliance with protocol [Time frame: 3 months]
Secondary outcome measures (3)
  • Number of treatment cycles [Time frame: 1 year]
  • Response rate Arm A [Time frame: 1 year]
  • ctDNA response rate Arm B [Time frame: 1 year]

Eligibility criteria

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 hormonal contraceptive are acceptable
  • Written and verbally informed consent

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Denmark · 2 centers
  • Aarhus University Hospital — Aarhus
  • Department pf Oncology, Vejle Hospital — Vejle

Identifiers

NCT: NCT06562348 · KFE 2406

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗