Metastatic colorectal cancer Cancer Malignant neoplasm of rectosigmoid junction
Conditions
Interventions
Treatment as well as routine and trial specific examinations will be conducted according to the following register:
Baseline: study registration followed by, for imaging analysis, fluorine-18 fluordeo
Sponsors
University of Heidelberg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed metastatic colorectal cancer 2. KRAS-wildtype status of the tumour 3. No history of therapy with an EGFR targeting agent 4. No history of previous chemotherapy for advanced disease 5. Measurable tumour lesion with a diameter no smaller than 1.0 cm detected by computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound 6. For contrast-enhanced ultrasound: metastases no smaller than 2.0 cm detected by ultrasound 7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 or Karnofsky performance scale minimum 60% 8. Life expectancy greater than 12 weeks 9. Age greater than or equal to 18 years, either sex 10. Adequate haematologic, renal and hepatic function 11. Ability of the patient to understand the character and individual consequences of this clinical trial 12. Written informed consent (must be available before enrolment in the trial) 13. For women and men with childbearing potential adequate double barrier contraception, for women: negative pregnancy test 14. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion criteria
Exclusion criteria: 1. Any contraindications for chemotherapy according to the Folfiri regimen 2. Non-curatively treated malignancy within the last 5 years 3. Uncontrolled or insulin-depending diabetes mellitus 4. Evidence of central nervous system (CNS) metastases 5. Uncontrolled infection 6. Significant cardiac disease (unstable angina pectoris or cardia symptoms according to New York Heart Association [NYHA] classification III or IV) 7. Active serious illness which renders the patient unsuitable for study entrance or multiple blood sampling 8. Pregnancy and lactation 9. History of hypersensitivity to cetuximab or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product 10. Participation in other clinical trials or observation period of competing trials, respectively 11. No patient will be allowed to enrol in this trial more than once
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the prognostic relevance of relative changes in SUV (delta-SUV; as measured in 18F-FDG PET-CT at day 14 versus baseline) for early clinical response (as defined by Response Evaluation Criteria In Solid Tumours [RECIST], measured at day 56) during short-term single agent treatment with the EGFR-mAB cetuximab. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To investigate duration of PFS as well as the influence of changes in individual SUV and of early clinical response on PFS 2. To investigate duration of overall survival (OS) 3. The assessment of antivascular/antiangiogenic effects of cetuximab by contrast-enhanced ultrasound This clinical trial will include an accompanying research component involving collection of biological samples for pseudonymised analyses. These will comprise sequential serum protein marker assessments (e.g., multiplex cytokine immune monitoring) as well as baseline analysis of tumour proteins and tumour genes, (e.g., PTEN expression, mutations in EGFR dependent downstream kinases like PI-3-kinase, BRAF and EGFR gene expression as measured by fluorescence-in-situ hybridisation). Patients may participate in this study even if they choose not to participate in this component. | — |
Countries
Germany
Outcome results
None listed