drugset / Trial / NCT00004011
S9900: Surgery With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Phase 3
Completed
354 enrolled
SWOG Cancer Research Network
Eastern Cooperative Oncology Group · collabNational Cancer Institute (NCI) · collabNorth Central Cancer Treatment Group · collabRadiation Therapy Oncology Group · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 1999-10
- Primary completion
- 2005-05
- Completion
- 2012-11
Outcome
Missed primary endpoint
paper (hazard ratio, 0.79; 95% CI, 0.60 to 1.06; P = .11.) PMID 20231678 ↗
Publications
- Results Pisters KM, Vallieres E, Crowley JJ, Franklin WA, Bunn PA Jr, Ginsberg RJ, Putnam JB Jr, Chansky K, Gandara D. Surgery with or without preoperative paclitaxel and carboplatin in early-stage non-small-cell lung cancer: Southwest Oncology Group Trial S9900, an intergroup, randomized, phase III trial. J Clin Oncol. 2010 Apr 10;28(11):1843-9. doi: 10.1200/JCO.2009.26.1685. Epub 2010 Mar 15.
- Results Pisters K, Vallieres E, Bunn PA, et al.: S9900: surgery alone or surgery plus induction (ind) paclitaxel/carboplatin (PC) chemotherapy in early stage non-small cell lung cancer (NSCLC): follow-up on a phase III trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7520, 389s, 2007.
- Results Pisters K, Vallieres E, Bunn P, et al.: S9900: a phase III trial of surgery alone or surgery plus preoperative (preop) paclitaxel/carboplatin (PC) chemotherapy in early stage non-small cell lung cancer (NSCLC): preliminary results. [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7012, 624s, 2005.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Paclitaxel | Small molecule | 225 mg/m2 | Intravenous |