OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer

NCT04680260 | Recruiting Phase 2 DMC

• 1 other identifier: KFE2022
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

Circulating tumor DNA; Adjuvant chemotherapy; Colorectal cancer; Metastatic

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Rate

  Rate of patients free from recurrent colorectal cancer at 2 years post local treatment

  2 years

Secondary Outcomes (10)

• Toxicity of treatment

  6 months post-treatment

• Molecular biological response to therapy

  6 months post-treatment

• Molecular biological Disease Free Survival

  1 year from inclusion

• Time to molecular biological recurrence

  5 years last patient

• Time to radiological recurrence

  5 years last patient

Study Arms (2)

A: Standard of care

ACTIVE COMPARATOR

Standard decision making regarding adjuvant chemotherapy with fluoropyrimidine and oxaliplatin as per institutional standards.

Other: Standard of care

B: ctDNA guided therapy approach

EXPERIMENTAL

Post ablation ctDNA results will be used for treatment decision.

Other: Circulating tumor DNA guided treatment approach

Interventions

Standard of care OTHER

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.

A: Standard of care

Circulating tumor DNA guided treatment approach OTHER

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.

B: ctDNA 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Department of Oncology, Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Department pf Oncology, Vejle Hospital

Vejle, 7100, Denmark

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal 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, Professor

  Department of Oncology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen-Lise G Spindler, Professor

CONTACT

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

Study Design

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

Model Details: An open label 1:1 randomized phase II exploratory study

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: December 22, 2020
• Study Start: October 25, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2030
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

DK (2)