Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MRC-LU22 | |||
| EORTC-08012 | |||
| EU-97016 | |||
| ISRCTN25582437 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo surgical resection no more than 4 weeks after randomization.
Arm II: Patients receive one of the following chemotherapy regimens immediately after randomization:
Quality of life is assessed at 6 and 12 months and then annually thereafter.
Patients are followed 1 month after surgery, 6 months after randomization, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| cisplatin | Drug | |||
| docetaxel | Drug | |||
| gemcitabine hydrochloride | Drug | |||
| ifosfamide | Drug | |||
| mitomycin C | Drug | |||
| paclitaxel | Drug | |||
| vinblastine sulfate |
| Measure | Description | Time Frame |
|---|---|---|
| Survival |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter | ||
| Clinical and post-surgery pathological staging at pre-randomization | ||
Not provided
DISEASE CHARACTERISTICS:
Histologically proven non-small cell lung cancer
No evidence of distant metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian Hodson | Medical Research Council | |
| Ian E. Smith, MD | Royal Marsden NHS Foundation Trust |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Council Clinical Trials Unit | London | England | NW1 2DA | United Kingdom | ||
| Royal Marsden NHS Foundation Trust - Surrey |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17544497 | Result | Gilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, Hatton M, Hopwood P, Manegold C, Schramel F, Smit H, van Meerbeeck J, Nankivell M, Parmar M, Pugh C, Stephens R. Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review. Lancet. 2007 Jun 9;369(9577):1929-37. doi: 10.1016/S0140-6736(07)60714-4. | |
| Result | Hopwood P, Nankivell M, Pugh C, et al.: Impact of pre-operative chemotherapy on the quality of life (QL) of patients with resectable non-small cell lung cancer (NSCLC): experience from the MRC LU22/NVALT/EORTC 08012 multicentre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9020, 498s, 2007. | ||
| Result | Nicolson M, Gilligan D, Smith I, et al.: Pre-operative chemotherapy in patients with resectable non-small cell lung cancer (NSCLC): first results of the MRC LU22/NVALT/EORTC 08012 multi-centre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7518, 389s, 2007. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
| vinorelbine tartrate | Drug |
| conventional surgery | Procedure |
| neoadjuvant therapy | Procedure |
| Resectability rates |
| Extent of surgery |
| Time to and site of relapse |
| Tumor response to chemotherapy |
| Adverse effects of chemotherapy |
| Sutton |
| England |
| SM2 5PT |
| United Kingdom |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| D007069 | Ifosfamide |
| D016685 | Mitomycin |
| D017239 | Paclitaxel |
| D014747 | Vinblastine |
| D000077235 | Vinorelbine |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D001389 | Azirines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
Not provided
Not provided