Current Clinical Trials

Stage IIIB non-small cell lung cancer (NSCLC) is defined by the following clinical stage groupings:

• Any T, N3, M0
• T4, any N, M0

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

Patients with stage IIIB NSCLC do not benefit from surgery alone and are best managed by initial chemotherapy, chemotherapy plus radiation therapy, or radiation therapy alone, depending on the sites of tumor involvement and the performance status (PS) of the patient. Most patients with excellent PS are candidates for combined modality therapy; however, patients with malignant pleural effusion are rarely candidates for radiation therapy and should generally be treated similarly to stage IV patients. Many randomized studies, including the RTOG-8808 and ECOG-4588 trials, for example, of patients with unresectable stage III NSCLC show that treatment with neoadjuvant or concurrent cisplatin-based chemotherapy and radiation therapy to the chest is associated with improved survival compared with treatment that uses radiation therapy alone.[1-5] A meta-analysis of patient data from 11 randomized clinical trials showed that cisplatin-based combinations plus radiation therapy resulted in a 10% reduction in the risk of death compared with radiation therapy alone.[6]

Patients with stage IIIB disease with poor PS are candidates for chest radiation therapy to palliate pulmonary symptoms (e.g., cough, shortness of breath, hemoptysis, or pain).[7][Level of evidence: 3iiiC]

T4 or N3, M0

An occasional patient with supraclavicular node involvement, who is otherwise a good candidate for radiation therapy with curative intent, will survive 3 years. Although most of these patients do not achieve a complete response to radiation therapy, significant palliation often results. Patients with excellent PS and those who are found to have advanced-stage disease at the time of resection are most likely to benefit from radiation therapy.[8] Adjuvant systemic chemotherapy with radiation therapy has been tested in randomized trials for patients with inoperable or unresectable locoregional NSCLC.[1-3,9] Some patients have shown a modest survival advantage with adjuvant chemotherapy. The addition of chemotherapy to radiation therapy has been reported to improve long-term survival in some[1,3,4] but not all[10] prospective clinical studies. A meta-analysis of patient data from 54 randomized clinical trials showed an absolute survival benefit of 4% at 2 years with the addition of cisplatin-based chemotherapy to radiation therapy.[11] The optimal sequencing of modalities is yet to be determined and is under study in clinical trials including the RTOG-9410 trial, for example.

Because of the poor overall results, these patients are candidates for clinical trials that examine new fractionation schedules, radiosensitizers, and combined modality approaches, which may lead to improvement in the control of disease.

Patients with NSCLC can present with superior vena cava syndrome. (Refer to the PDQ summary on Cardiopulmonary Syndromes for more information.) Regardless of the clinical stage, this problem should generally be managed with radiation therapy with or without chemotherapy.

Treatment options:

1. Radiation therapy alone.[7,12]



2. Chemotherapy combined with radiation therapy.[1-3,9]



3. Chemotherapy and concurrent radiation therapy followed by resection, as evidenced in the SWOG-8805 trial, for example.[13,14]



4. Chemotherapy alone.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage IIIB non-small cell lung cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Le Chevalier T, Arriagada R, Quoix E, et al.: Radiotherapy alone versus combined chemotherapy and radiotherapy in nonresectable non-small-cell lung cancer: first analysis of a randomized trial in 353 patients. J Natl Cancer Inst 83 (6): 417-23, 1991.  [PUBMED Abstract]
   
   
2. Morton RF, Jett JR, McGinnis WL, et al.: Thoracic radiation therapy alone compared with combined chemoradiotherapy for locally unresectable non-small cell lung cancer. A randomized, phase III trial. Ann Intern Med 115 (9): 681-6, 1991.  [PUBMED Abstract]
   
   
3. Dillman RO, Seagren SL, Propert KJ, et al.: A randomized trial of induction chemotherapy plus high-dose radiation versus radiation alone in stage III non-small-cell lung cancer. N Engl J Med 323 (14): 940-5, 1990.  [PUBMED Abstract]
   
   
4. Schaake-Koning C, van den Bogaert W, Dalesio O, et al.: Effects of concomitant cisplatin and radiotherapy on inoperable non-small-cell lung cancer. N Engl J Med 326 (8): 524-30, 1992.  [PUBMED Abstract]
   
   
5. Sause WT, Scott C, Taylor S, et al.: Radiation Therapy Oncology Group (RTOG) 88-08 and Eastern Cooperative Oncology Group (ECOG) 4588: preliminary results of a phase III trial in regionally advanced, unresectable non-small-cell lung cancer. J Natl Cancer Inst 87 (3): 198-205, 1995.  [PUBMED Abstract]
   
   
6. Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ 311 (7010): 899-909, 1995.  [PUBMED Abstract]
   
   
7. Langendijk JA, ten Velde GP, Aaronson NK, et al.: Quality of life after palliative radiotherapy in non-small cell lung cancer: a prospective study. Int J Radiat Oncol Biol Phys 47 (1): 149-55, 2000.  [PUBMED Abstract]
   
   
8. Komaki R, Cox JD, Hartz AJ, et al.: Characteristics of long-term survivors after treatment for inoperable carcinoma of the lung. Am J Clin Oncol 8 (5): 362-70, 1985.  [PUBMED Abstract]
   
   
9. Pfister DG, Johnson DH, Azzoli CG, et al.: American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 22 (2): 330-53, 2004.  [PUBMED Abstract]
   
   
10. Blanke C, Ansari R, Mantravadi R, et al.: Phase III trial of thoracic irradiation with or without cisplatin for locally advanced unresectable non-small-cell lung cancer: a Hoosier Oncology Group protocol. J Clin Oncol 13 (6): 1425-9, 1995.  [PUBMED Abstract]
    
    
11. Pignon JP, Stewart LA, Souhami RL, et al.: A meta-analysis using individual patient data from randomised clinical trials (RCTS) of chemotherapy (CT) in non-small cell lung cancer (NSCLC): (2) survival in the locally advanced (LA) setting. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1109, 334, 1994. 
    
    
12. Sundstrøm S, Bremnes R, Aasebø U, et al.: Hypofractionated palliative radiotherapy (17 Gy per two fractions) in advanced non-small-cell lung carcinoma is comparable to standard fractionation for symptom control and survival: a national phase III trial. J Clin Oncol 22 (5): 801-10, 2004.  [PUBMED Abstract]
    
    
13. Rusch VW, Albain KS, Crowley JJ, et al.: Surgical resection of stage IIIA and stage IIIB non-small-cell lung cancer after concurrent induction chemoradiotherapy. A Southwest Oncology Group trial. J Thorac Cardiovasc Surg 105 (1): 97-104; discussion 104-6, 1993.  [PUBMED Abstract]
    
    
14. Albain KS, Rusch VW, Crowley JJ, et al.: Concurrent cisplatin/etoposide plus chest radiotherapy followed by surgery for stages IIIA (N2) and IIIB non-small-cell lung cancer: mature results of Southwest Oncology Group phase II study 8805. J Clin Oncol 13 (8): 1880-92, 1995.  [PUBMED Abstract]
    
    

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