Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04680260

OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer

Led by Karen-Lise Garm Spindler · Updated on 2024-08-14

350

Participants Needed

2

Research Sites

435 weeks

Total Duration

On this page

Sponsors

K

Karen-Lise Garm Spindler

Lead Sponsor

V

Vejle Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Radical intended treatment for metastatic spread from colorectal cancer by resection, radiofrequency ablation, stereotactic body radiation therapy, or other experimental local treatments (excluding cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy)
  • No evidence of further disease based on pre-treatment work-up according to standard of care
  • Age 18 years or older
  • Eastern Cooperative Oncology Group performance status 0-2
  • Clinically eligible for adjuvant triple combination chemotherapy as decided by investigator
  • Adequate bone marrow, liver, and kidney function suitable for systemic chemotherapy (specified blood counts and liver enzyme limits, and kidney filtration rate at least 30 mL/min)
  • Use of contraception for fertile women and male patients with fertile partners (intrauterine device, vasectomy, or hormonal contraceptives acceptable)
  • Provided written and verbal informed consent
Not Eligible

You will not qualify if you...

  • Radiological evidence of distant metastases on CT scans of chest, abdomen, and pelvis
  • Incapacity, frailty, disability, or comorbidities making triple combination chemotherapy unsuitable
  • Neuropathy grade higher than 1 according to NCI-CTCAE
  • Other malignant tumors within 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix
  • Pregnant or breastfeeding women
  • Intolerance or allergy to 5-FU, leucovorin, oxaliplatin, irinotecan, or capecitabine

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Department of Oncology, Aarhus University Hospital

Aarhus N, Denmark, 8200

Actively Recruiting

2

Department pf Oncology, Vejle Hospital

Vejle, Denmark, 7100

Actively Recruiting

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Research Team

K

Karen-Lise G Spindler, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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