Neo-adjuvant Treatment in Non-Small Cell Lung Cancer (NSCLC)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preoperative Chemotherapy and Radiotherapy Concomitant to Cetuximab in Non-Small Cell Lung Cancer (NSCLC) Patients With IIIB Disease - A Multicenter Phase II Trial|
- Progression-free survival [ Time Frame: at 1 year (+/- 1 month) ] [ Designated as safety issue: No ]
- Treatment-related death during chemoimmunotherapy, radioimmunotherapy, and perioperatively [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
- Metabolic response evaluated by PET [ Time Frame: At baseline and after chemo-immunotherapy ] [ Designated as safety issue: No ]
- Response status after chemoimmunotherapy and radioimmunotherapy [ Time Frame: After chemoimmunotherapy and after radioimmunotherapy ] [ Designated as safety issue: No ]
- Complete pathological response [ Time Frame: After surgery ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: At the end of the follow-up phase (max. 5 years after treatment termination or surgery) ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: During the all trial treatment until 30 days after surgery or treatment stop ] [ Designated as safety issue: Yes ]
- Operability [ Time Frame: Before trial treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|Experimental: Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery||
400 mg/m2 initial dose on day 1 250 mg/m2 weekly starting on day 8 and for 12 weeks
Other Name: ErbituxDrug: cisplatin
50 mg/m2 on day 1 and 2 of 21 day cycles, for 3 cycles
Other Name: PlatinDrug: docetaxel
85 mg/m2 day 1 of 21 day cycles, for 3 cycles
Other Name: TaxotereRadiation: Radiotherapy
44 Gy (PTV1=30 Gy, PTV2=14 Gy), for 3 weeks, after the 3 cycles of Cisplatin / Docetaxel treatmentProcedure: Surgery
Ipsilateral formal mediastinal lymphadenectomy. In case of involved N3 lymph nodes, resection of the precarinal and contralateral nodes.
- To evaluate the efficacy and safety of neoadjuvant sequential chemoimmunotherapy comprising cetuximab, cisplatin, and docetaxel before radiotherapy and cetuximab followed by surgery in patients with resectable stage IIIB non-small cell lung cancer.
OUTLINE: This is a multicenter study.
- Chemoimmunotherapy (courses 1-3): Patients receive chemoimmunotherapy comprising cetuximab IV over 1-2 hours on days 1, 8, and 15; cisplatin IV over 1 hour on days 1 and 2; and docetaxel IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) on days 3-8 or a single dose of pegfilgrastim the day after chemotherapy. Treatment repeats every 3 weeks for 3 courses.
- Radiotherapy (course 4): Beginning on day 1 of week 10, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy 5 days a week for 3 weeks. Patients also receive cetuximab IV over 1 hour on days 1, 8, and 15.
- Surgery: Beginning 21-28 days after completion of radiotherapy, patients undergo surgery.
After completion of study treatment, patients are followed every 3 months for 2 years and every 6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059188
|Saint Claraspital AG|
|Basel, Switzerland, CH-4016|
|Basel, Switzerland, CH-4031|
|Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni|
|Bellinzona, Switzerland, CH-6500|
|Bern, Switzerland, CH-3010|
|Biel, Switzerland, CH-2501|
|Bruderholz, Switzerland, CH-4101|
|Chur, Switzerland, CH-7000|
|Fribourg, Switzerland, 1708|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Liestal, Switzerland, CH-4410|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Thun, Switzerland, 3600|
|Winterthur, Switzerland, CH-8400|
|Zurich, Switzerland, CH-8091|
|Study Chair:||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|