NCT00004011
S9900: Surgery With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
PHASE3
COMPLETED
NCT00004011
INTERVENTIONAL
A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB (T2N0), II (T1-2N1, T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if surgery plus combination chemotherapy is more effective than surgery alone for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have non-small cell lung cancer.
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:
* Stage IB (T2, N0)
* Stage II
* T1-2, N1 with negative mediastinoscopy OR
* T3, N0
* Selected stage IIIA with negative mediastinoscopies
* T3, N1, excluding superior sulcus
* Positive level 10 hilar nodes allowed if mediastinoscopy negative
* Apical tumors with no clinical symptoms allowed
* No symptomatic tumors (T3, N0 or T3, N1) involving the superior sulcus
* No Pancoast's tumors
* Negative mediastinoscopy required in all patients with clinically positive mediastinal or hilar lymph nodes to ensure no N2 disease
* Bidimensionally measurable or evaluable disease by chest x-ray or contrast-enhanced CT scan
* T3, N0 disease assessable only by bronchoscopy must be affirmed by 2 observers and documented by photograph that includes main carina
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0 or 1
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* WBC at least 4,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2 times ULN
* Alkaline phosphatase no greater than 2 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance at least 50 mL/min
Pulmonary:
* See Disease Characteristics
* Preresection FEV_1 greater than 2.0 L OR
* Predicted postresection FEV_1 greater than 1.0 L
* No postobstructive pneumonia
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious infection
* No other serious medical condition that would preclude study compliance
* No prior allergic reactions to drugs containing Cremophor
* No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior systemic chemotherapy for NSCLC
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior systemic radiotherapy for NSCLC
* No concurrent radiotherapy
Surgery:
* At least 5 years since prior resection of lung disease
Other:
* No other concurrent investigational therapy
* No other concurrent anticancer therapy
Lung Cancer
- TREATMENT
-
- Type: DRUG
- Name: carboplatin
- Description:
- Arm Group Labels: preooperative chemo followed by surgery
-
- Type: DRUG
- Name: paclitaxel
- Description:
- Arm Group Labels: preooperative chemo followed by surgery
-
- Type: PROCEDURE
- Name: conventional surgery
- Description:
- Arm Group Labels: Surgery alone, preooperative chemo followed by surgery
- SWOG Cancer Research Network