Clinical trial · Interventional
IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer
Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer
NCT03748680CI-TRIAL-00056760IMPROVE-ITunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A open label 1:1 randomized phase II exploratory study investigating adjuvant therapy in patients with molecular biologically detectable residual disease after primary resection for localized colorectal tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Chemotherapy | — | UNRESOLVED | — |
| Circulating Tumor DNA | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Progression Free Survival | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy | Drug | — | UNRESOLVED |
| Intensified Follow-up Schedule | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Intensified follow-up schedule
- interventionNames
- Other: Intensified Follow-up Schedule
- type
- EXPERIMENTAL
- label
- B
- description
- Adjuvant chemotherapy + intensified follow-up schedule
- interventionNames
- Drug: Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy
Primary outcomes (1)
- measure
- DFS
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Surgically removed Adenocarcinoma of the colon or rectum * Pathologically stage I or II disease, and radical resection * Detectable ctDNA in two weeks postoperative plasma sample * No indication for adjuvant chemotherapy according to DCCG guidelines (website) * Age at least 18 years * ECOG performance status 0-2 * Clinically eligible for adjuvant chemotherapy 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 and abdomen * Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy * Previous treatment with 5FU or oxaliplatin * Neuropathy NCI 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
References
Publications (0)
Data not yet available
No reference posted for this study.