A Phase 2 interventional study of Standard of care and Circulating tumor DNA guided treatment approach in Colorectal Cancer and Metastatic Cancer, sponsored by Karen-Lise Garm Spindler. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Karen-Lise Garm Spindler · Phase 2, Interventional, and Treatment
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 350 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Karen-Lise Garm Spindler is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard decision making regarding adjuvant chemotherapy with fluoropyrimidine and oxaliplatin as per institutional standards.
Other: Standard of care
Post ablation ctDNA results will be used for treatment decision.
Other: Circulating tumor DNA guided treatment approach
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.
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.
Recurrence Free Rate
Rate of patients free from recurrent colorectal cancer at 2 years post local treatment
Time frame: 2 years
Toxicity of treatment
Rate of grade 3-4 toxicity according to CTCAE version 5
Time frame: 6 months post-treatment
Molecular biological response to therapy
Rate of patients with lack of detectable tumor DNA in plasma samples
Time frame: 6 months post-treatment
Molecular biological Disease Free Survival
Rate of patients with no detectable ctDNA
Time frame: 1 year from inclusion
Time to molecular biological recurrence
Time to molecular biological recurrence is calculated from first time of no detectable DNA until detectable DNA in a samples
Time frame: 5 years last patient
Time to radiological recurrence
Time to radiological recurrence is calculated from inclusion until radiological evidence of disease recurrence
Time frame: 5 years last patient
Local and distant relapse
Rate of patients with local and distant relapse
Time frame: 5 years last patient
Overall survival
Time from inclusion to death from any cause
Time frame: 5 years last patient
Quality of life according to EORTC QLQ-CR29 and -C30
The EORTC QLQ-CR29 is a tumor-specific health related QoL questionnaire module for CRC patients, which complement the EORTC QLQ-C30 questionnaire. Patients indicate their symptoms during the past week(s). Scores can be linearly transformed to a score from 0-100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Time frame: 5 years last patient
Quality of life according to EQ-5D-5L
The EQ-5D-5L essentially consists of: the EQ-5D descriptive system and the EQ visual analogue scale. The descriptive system comprises 5 dimensions. Each dimension has 5 levels. The patient is asked to indicate his/her health. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state.The EQ VAS records the patient's self-rated health on a vertical visual analogue scale.
Time frame: 5 years last patient
Cost-effectiveness analysis
Economic evaluation of ctDNA guided chemotherapy after curative treatment of metastatic colorectal cancer
Time frame: 5 years last patient
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Karen-Lise Garm Spindler