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| ID | Type | Description | Link |
|---|---|---|---|
| SWS-SAKK-16/08 | |||
| EU-21002 | |||
| CDR0000664070 |
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RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying the side effects of giving cetuximab together with cisplatin and docetaxel before radiation therapy and cetuximab followed by surgery and to see how well it works in treating patients with stage IIIB non-small cell lung cancer that can be removed by surgery.
OBJECTIVES:
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed every 3 months for 2 years and every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Drug | 400 mg/m2 initial dose on day 1 250 mg/m2 weekly starting on day 8 and for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | at 1 year (+/- 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related death during chemoimmunotherapy, radioimmunotherapy, and perioperatively | 30 days after surgery | |
| Metabolic response evaluated by PET | At baseline and after chemo-immunotherapy | |
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DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
Squamous, adeno, large cell, or poorly differentiated disease
Stage IIIB disease (T4N0-3M0 or T1-4N3M0) according to 6th TNM classification
Lymph node staging done by mediastinoscopy (or EBUS) in N+ disease on PET-CT scan (SUV above mediastinum background SUV) or CT (size > 10 mm in the smallest diameter) within 42 days of registration
Measurable disease assessed by contrast-enhanced CT-scan within 28 days of registration
Tumor tissue available for translational research (no cytology)
Resectable disease based on a multidisciplinary tumor board decision
No brain metastasis (confirmed by MRI within 42 days of registration)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Solange Peters, MD | Centre Hospitalier Universitaire Vaudois | Study Chair |
| Daniel C. Betticher, MD | Kantonsspital Freiburg | Study Chair |
| Miklos Pless, Prof | Kantonsspital Winterthur KSW | Study Chair |
| Roger Stupp, MD | Centre Hospitalier Universitaire Vaudois | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Claraspital AG | Basel | CH-4016 | Switzerland | |||
| Universitaetsspital-Basel |
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| cisplatin | Drug | 50 mg/m2 on day 1 and 2 of 21 day cycles, for 3 cycles |
|
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| docetaxel | Drug | 85 mg/m2 day 1 of 21 day cycles, for 3 cycles |
|
|
| Radiotherapy | Radiation | 44 Gy (PTV1=30 Gy, PTV2=14 Gy), for 3 weeks, after the 3 cycles of Cisplatin / Docetaxel treatment |
|
| Surgery | Procedure | Ipsilateral formal mediastinal lymphadenectomy. In case of involved N3 lymph nodes, resection of the precarinal and contralateral nodes. |
|
| Response status after chemoimmunotherapy and radioimmunotherapy |
| After chemoimmunotherapy and after radioimmunotherapy |
| Complete pathological response | After surgery |
| Overall survival | At the end of the follow-up phase (max. 5 years after treatment termination or surgery) |
| Adverse events | During the all trial treatment until 30 days after surgery or treatment stop |
| Operability | Before trial treatment |
| Basel |
| CH-4031 |
| Switzerland |
| Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni | Bellinzona | CH-6500 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Spitalzentrum Biel | Biel | CH-2501 | Switzerland |
| Kantonsspital Bruderholz | Bruderholz | CH-4101 | Switzerland |
| Kantonsspital Graubuenden | Chur | CH-7000 | Switzerland |
| Hopital Fribourgeois | Fribourg | 1708 | Switzerland |
| Hopital Cantonal Universitaire de Geneve | Geneva | CH-1211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Kantonsspital Liestal | Liestal | CH-4410 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Regionalspital | Thun | 3600 | Switzerland |
| Kantonsspital Winterthur | Winterthur | CH-8400 | Switzerland |
| UniversitaetsSpital Zuerich | Zurich | CH-8091 | Switzerland |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D011878 | Radiotherapy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
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