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| Name | Class |
|---|---|
| Vejle Hospital | OTHER |
| Zealand University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Standard of care | Active Comparator | Standard decision making regarding adjuvant chemotherapy with fluoropyrimidine and oxaliplatin as per institutional standards. |
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| B: ctDNA guided therapy approach | Experimental | Post ablation ctDNA results will be used for treatment decision. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Free Rate | Rate of patients free from recurrent colorectal cancer at 2 years post local treatment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of treatment | Rate of grade 3-4 toxicity according to CTCAE version 5 | 6 months post-treatment |
| Molecular biological response to therapy | Rate of patients with lack of detectable tumor DNA in plasma samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen-Lise G Spindler, Professor | Contact | +4591167244 | k.g.spindler@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Karen-Lise G Spindler, Professor | Department of Oncology, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Aarhus University Hospital | Recruiting | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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An open label 1:1 randomized phase II exploratory study
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| 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. |
|
| 6 months post-treatment |
| Molecular biological Disease Free Survival | Rate of patients with no detectable ctDNA | 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 | 5 years last patient |
| Time to radiological recurrence | Time to radiological recurrence is calculated from inclusion until radiological evidence of disease recurrence | 5 years last patient |
| Local and distant relapse | Rate of patients with local and distant relapse | 5 years last patient |
| Overall survival | Time from inclusion to death from any cause | 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. | 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. | 5 years last patient |
| Cost-effectiveness analysis | Economic evaluation of ctDNA guided chemotherapy after curative treatment of metastatic colorectal cancer | 5 years last patient |
| Department pf Oncology, Vejle Hospital | Recruiting | Vejle | 7100 | Denmark |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |