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One of the participating specialties has decided to no longer cooperate in this research
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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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Cetuximab to reduce the amound of circulating tumor cells in early stage NSCLC
A multicenter single arm phase II trial. 40 patients with pathology proven stage I-IIIA NSCLC that are eligible for resection will be enrolled in this study. All patients will receive one dose of cetuximab prior to surgery. Blood will be drawn on multiple timepoints to assess te amount of circulating tumor cells
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose cetuximab prior to surgery | Experimental | A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction of circulating tumor cells | The primary objective of this study is to determine whether a single neoadjuvant dose of cetuximab (anti-EGFR mAb) - administered 72 to 48 hours prior to surgery - will reduce the number of CTCs in patients. The reduction of CTCs will be expressed in percentage as more or less than 50% changed from baseline. | From date of registration until CTC measurement at 3 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| the reduction of CTC's in percentage as a continuous variable | the reduction of CTC's in percentage as a continuous variable will be assesed | From date of registration until CTC measurement at 3 months after surgery. |
| plasma ability killing tumor cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Egbert Smit, prof | The Netherlands Cancer Institute-Antoni van Leeuwenhoek | Principal Investigator |
| Marjolein van Egmond, prof | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC - VUMC | Amsterdam | Netherlands | ||||
| Leiden University Medical Center |
to be decided
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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the concentration of plasma who have the ability to inhibit growth in patients treated with cetuximab, ADCP and/or ADCC of tumor cells by cytotoxic immune effector cells |
| From date of registration until CTC measurement at 3 months after surgery. |
| disease free survival | Although this study is not powered for disease free survival, we will conduct follow-up of all the patients in order to get preliminary information about potential clinical efficacy | From date of surgery to until the date of first documented progression or date of death from any cause. |
| safety | Safety and toxicity will also be studied. All adverse events and SUSARS will be scored using the common Terminology Criteria for Adverse Events (CTCAE). | From date of registration until CTC measurement at 3 months after surgery. |
| Leiden |
| Netherlands |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |