Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	over 18	NCI	RTOG-8808 EST-4588, SWOG-8992, RTOG-88-08

Objectives

I.  Compare survival and response rates of patients with Stages II/IIIA/IIIB 
non-small cell lung cancer randomly assigned to treatment with 
standard-fractionation radiotherapy alone vs. chemotherapy with 
vinblastine/cisplatin followed by radiotherapy vs. hyperfractionated 
radiotherapy.
II.  Define and compare the toxicities of these therapeutic regimens.

Entry Criteria

Disease Characteristics:

Locoregionally advanced, measurable or evaluable non-small
cell lung cancer Stages II, IIIA, and IIIB

Primary tumor and/or regional lymphatic metastases must be
evaluable radiographically

Patients with recurrence following potentially curative
resection excluded

No pleural effusions

No unexplained abnormalities of liver function tests

Must be ineligible for protocol RTOG-8901

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  Recurrence following potentially curative resection not
  allowed

Patient Characteristics:

Age:
  Over 18

Performance status:
  Karnofsky 70-100% (ECOG 0 or 1)

Hematopoietic:
  WBC at least 4,000
  Platelets at least 100,000
  Hb at least 10 g/dl (may transfuse)

Hepatic:
  Not specified

Renal:
  Creatinine no greater than 1.5 mg/dl

Cardiovascular:
  No symptomatic heart disease, e.g.,
    No angina
    No CHF
    No uncontrolled arrhythmia
    No MI within 6 months

Other:
  Less than 5% weight loss during 3 months prior to diagnosis

  No second malignancy within previous 5 years except
  nonmelanomatous skin cancer

Expected Enrollment

483 patients will be entered; the anticipated accrual rate is 15 patients/month.

Outline

Randomized study.
Arm I:  Radiotherapy.  Standard Irradiation of primary tumor and draining 
lymphatics using megavoltage equipment with effective photon energies of 
greater than 1 MeV (electrons may be used to boost the supraclavicular nodes).
Arm II:  2-Drug Combination Chemotherapy followed by Radiotherapy.  
Vinblastine, VBL, NSC-49842; Cisplatin, DDP, CACP, NSC-119875; followed by 
standard irradiation as on Arm I.
Arm III:  Radiotherapy.  Irradiation as on Arm I but using hyperfractionated 
schedule.

Sause W, Kolesar P, Taylor S IV, et al.: Final results of phase III trial in regionally advanced unresectable non-small cell lung cancer: Radiation Therapy Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group. Chest 117 (2): 358-64, 2000.[PUBMED Abstract]

Orton CG, Chungbin S, Klein EE, et al.: Study of lung density corrections in a clinical trial (RTOG 88-08). Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys 41 (4): 787-94, 1998.[PUBMED Abstract]

Sause W, Kolesar P, Taylor S, et al.: Five year results: phase III trial of regionally advanced unresectable non-small cell lung cancer, RTOG-8808, ECOG-4588, SWOG-8892. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1743, 453a, 1998.

Komaki R, Scott CB, Sause WT, et al.: Induction cisplatin/vinblastine and irradiation vs. irradiation in unresectable squamous cell lung cancer: failure patterns by cell type in RTOG 88-08/ECOG 4588. Radiation Therapy Oncology Group. Eastern Cooperative Oncology Group. Int J Radiat Oncol Biol Phys 39 (3): 537-44, 1997.[PUBMED Abstract]

Komaki R, Scott CB, Sause WT, et al.: Induction cisplatin/vinblastine decreased distant metastasis in unresectable squamous cell lung cancer (SCC): failure patterns in RTOG 88-08/ECOG 4588. [Abstract] Int J Radiat Oncol Biol Phys 36 (1 suppl 1): A-96, 206, 1996.

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]

Sause W, Scott C, Taylor S, et al.: RTOG 8808 ECOG 4588, preliminary analysis of a phase III trial in regionally advanced unresectable non-small cell lung cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1072, 325, 1994.

Machtay M, Swann S, Komaki R, et al.: What is the meaning of local-regional control after chemoradiation for locally advanced NSCLC? An RTOG analysis. [Abstract] Lung Cancer 50 (Suppl 2): A-O-041, S17, 2005.

Firat S, Byhardt RW, Gore E: Comorbidity and Karnofksy performance score are independent prognostic factors in stage III non-small-cell lung cancer: an institutional analysis of patients treated on four RTOG studies. Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys 54 (2): 357-64, 2002.[PUBMED Abstract]

Movsas B, Scott C, Sause W, et al.: Age dramatically impacts on the quality-adjusted time without symptoms of toxicity (Q-Twist) in locally advanced non-small cell lung cancer (LA-NSCLC): a RTOG analysis. [Abstract] Int J Radiat Oncol Biol Phys 48 (3 suppl): A-92, 157-158, 2000.

Sause W, Scott C, Byhardt R, et al.: Combined chemotheray radiation therapy treatment in unresected non-small cell lung cancer: Radiation Therapy Oncology Group (RTOG) experience. Lung Cancer 29(suppl 2): 2000.

Werner-Wasik M, Scott C, Cox JD, et al.: Recursive partitioning analysis of 1999 Radiation Therapy Oncology Group (RTOG) patients with locally-advanced non-small-cell lung cancer (LA-NSCLC): identification of five groups with different survival. Int J Radiat Oncol Biol Phys 48 (5): 1475-82, 2000.[PUBMED Abstract]

Cox JD, Scott CB, Byhardt RW, et al.: Addition of chemotherapy to radiation therapy alters failure patterns by cell type within non-small cell carcinoma of lung (NSCCL): analysis of radiation therapy oncology group (RTOG) trials. Int J Radiat Oncol Biol Phys 43 (3): 505-9, 1999.[PUBMED Abstract]

Machtay M, Seiferheld W, Komaki R, et al.: Is prolonged survival possible for patients with supraclavicular node metastases in non-small cell lung cancer treated with chemoradiotherapy?: Analysis of the Radiation Therapy Oncology Group experience. Int J Radiat Oncol Biol Phys 44 (4): 847-53, 1999.[PUBMED Abstract]

Movsas B, Scott C, Sause W, et al.: The benefit of treatment intensification is age and histology-dependent in patients with locally advanced non-small cell lung cancer (NSCLC): a quality-adjusted survival analysis of radiation therapy oncology group (RTOG) chemoradiation studies. Int J Radiat Oncol Biol Phys 45 (5): 1143-9, 1999.[PUBMED Abstract]

Werner-Wasik M, Scott C, Graham ML, et al.: Interfraction interval does not affect survival of patients with non-small cell lung cancer treated with chemotherapy and/or hyperfractionated radiotherapy: a multivariate analysis of 1076 RTOG patients. Int J Radiat Oncol Biol Phys 44 (2): 327-31, 1999.[PUBMED Abstract]

Byhardt RW, Scott C, Sause WT, et al.: Response, toxicity, failure patterns, and survival in five Radiation Therapy Oncology Group (RTOG) trials of sequential and/or concurrent chemotherapy and radiotherapy for locally advanced non-small-cell carcinoma of the lung. Int J Radiat Oncol Biol Phys 42 (3): 469-78, 1998.[PUBMED Abstract]

Scott C, Movsa SB, Sause W, et al.: Intensified treatment increases survival in patients with non-small cell lung cancer at what price? A quality-adjusted survival analysis of Radiation Therapy Oncology Group chemoradiation studies. [Abstract] Qual Life Res 6: A-345, 718, 1997.

Curran WJ: New chemotherapy/radiation therapy regiments may improve survival for patients with locally advanced unresectable non-small cell lung cancer. Cope-Working with Oncology Jan/Feb: 10-17, 1996.

Curran WJ, Scott CB, Komaki R, et al.: Response to induction chemotherapy does not predict for long term survival among patients with unresected stage III non-small cell lung cancer (NSCLC) receiving sequential chemo-radiation on RTOG 88-04 and 88-08. [Abstract] Int J Radiat Oncol Biol Phys 32 (suppl 1); A-111, 196, 1995.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

William Sause, MD, Protocol chair		Ph: 801-408-1146 Email: william.sause@intermountainmail.org

Eastern Cooperative Oncology Group

Andrew Turrisi, MD, Protocol chair(Contact information may not be current)		Ph: 843-792-3273

Southwest Oncology Group

Allen Lichter, MD, Protocol chair(Contact information may not be current)		Ph: 734-936-1831; 800-865-1125