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Recruiting NCT04680260

OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer

Phase II Interventional Colorectal Cancer Metastatic Cancer

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, Circulating tumor DNA guided treatment approach.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Metastatic Cancer. 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

OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer - a ctDNA Guided Phase II Randomized Approach

Overview

A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)

Detailed description

An open label 1:1 randomized phase II exploratory study investigating use of ctDNA-guided adjuvant chemotherapy compared to standard of care (SOC) after local treatment for metastatic colorectal cancer.

Patients are randomized 1:1 between SOC and ctDNA guided treatment and follow-up.

Escalation therapy comprises standard regimen of Fluorouracil (5-FU), Irinotecan and oxaliplatin (FOLFOXIRI), de-escalation therapy of monotherapy capecitabine or observation only. SOC is per institutional practice, based on national guidelines.

Interventions

  • Other Standard of care
    Patients will be offered adjuvant chemotherapy according to standard of care. Follow up will be performed with imaging according to standard guidelines, equal to the experimental arm. Blood samples will be analyzed retrospectively to evaluate the ctDNA status.
  • Other Circulating tumor DNA guided treatment approach
    Circulating tumor-marker positivity will lead to escalation with 6 months of intensified chemotherapy consisting of 4 months of FOLFOXIRI followed by 2 months of 5FU monotherapy. Circulating tumor-marker negativity will based on shared decision-making lead to de-escalation i.e. possibilities for observation in patients otherwise eligible for monotherapy or observation/monotherapy in patients, otherwise eligible for combination chemotherapy according to standard of care.

Primary outcome measures

  • Recurrence Free Rate [Time frame: 2 years]
Secondary outcome measures (10)
  • Toxicity of treatment [Time frame: 6 months post-treatment]
  • Molecular biological response to therapy [Time frame: 6 months post-treatment]
  • Molecular biological Disease Free Survival [Time frame: 1 year from inclusion]
  • Time to molecular biological recurrence [Time frame: 5 years last patient]
  • Time to radiological recurrence [Time frame: 5 years last patient]
  • Local and distant relapse [Time frame: 5 years last patient]
  • Overall survival [Time frame: 5 years last patient]
  • Quality of life according to EORTC QLQ-CR29 and -C30 [Time frame: 5 years last patient]
  • Quality of life according to EQ-5D-5L [Time frame: 5 years last patient]
  • Cost-effectiveness analysis [Time frame: 5 years last patient]

Eligibility criteria

Inclusion criteria

  • Radical intended treatment for metastatic spread from CRC, by resection, radiofrequency ablation, stereotactic body radiation therapy (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC)
  • No evidence of further disease based on pre-treatment work-up according to SOC
  • Age at least 18 years
  • Eastern Cooperative Oncology Group performance status 0-2
  • Clinically eligible for adjuvant triple CT at investigators decision.
  • Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and calculated or measured renal glomerular filtration rate at least 30 mL/min)
  • 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

  • Radiological evidence of distant metastasis, by CT- chest, abdomen, and pelvis
  • Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with triple combination chemotherapy
  • Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1
  • Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri
  • Pregnant (positive pregnancy test) or breast feeding women
  • Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabine

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
Treatment

Study locations

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

Identifiers

NCT: NCT04680260 · KFE2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗