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Clinical Trials (PDQ®)

  • Last Modified: 5/1/1991

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Clinical Trials (PDQ®)

NCI HIGH PRIORITY CLINICAL TRIAL --- Phase III Study of CACP/VP-16 Combined with Standard Fractionation Thoracic Radiotherapy vs CACP/VP-16 Combined with Hyperfractionated Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompletedany ageNCIEST-3588
RTOG-8815, SWOG-8991, INT-0096

Objectives

I.  Compare, in a randomized Phase III setting, median and long-term (greater 
than 2-year) survival of patients with limited stage small cell lung cancer 
who are receiving cisplatin/etoposide induction chemotherapy combined with 
concurrent thoracic radiotherapy given on a standard once daily vs. a twice 
daily fractionation scheme.
II.  Compare these regimens with regard to failure rates within the thorax, 
within the radiation portal, and at distant sites.
III.  Compare the toxicities of standard fractionated vs. hyperfractionated 
thoracic radiotherapy given concurrently with chemotherapy.
IV.  Determine the clinical significance of variant morphologies of small cell 
carcinoma of the lung.

Entry Criteria

Disease Characteristics:


Limited stage small cell lung cancer (i.e., disease confined
to 1 hemithorax that may include any mediastinal adenopathy
and ipsilateral supraclavicular nodes but no contralateral
hilar disease)

Histologic or cytologic proof of disease required
  Thin needle aspiration acceptable as cytologic
  documentation, as is sputum cytology if biopsy is
  impossible provided there are at least 2 positive specimens

Tumor must be encompassable within a single radiotherapy port

No pericardial or pleural effusion

Measurable or evaluable disease required


Prior/Concurrent Therapy:


Biologic therapy:
  No prior biologic therapy

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  Not specified


Patient Characteristics:


Age:
  Any age

Performance status:
  ECOG 0-2

Hematopoietic:
  WBC at least 4,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no more than 1.5 mg/dl
  SGOT no more than 2 x normal

Renal:
  Creatinine no more than 1.5 mg/dl

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

Pulmonary:
  FEV1 greater than 1 liter
  No uncontrolled bronchospasm in unaffected lung

Other:
  No previous or concurrent other malignancy except:
    Curatively treated basal or squamous cell skin cancer
    Carcinoma in situ of the cervix
    (Exceptions may be discussed with the study or
    disease-oriented chairperson)


Expected Enrollment

200 patients per arm will be entered.  At an anticipated accrual rate of 160 
patients/year, 2.5 years will be needed for accrual; an additional 2.5 years 
will be required for follow-up.

Outline

Randomized study.  Patients achieving CR on either arm may be given 
prophylactic cranial irradiation (PCI) on Regimen A; PCI is optional.  PCI may 
be given at the discretion of the patient's physician to patients achieving 
PR, but this practice is not encouraged.
Arm I:  2-Drug Combination Chemotherapy plus Radiotherapy.  Cisplatin, CACP, 
NSC-119875; Etoposide, VP-16, NSC-141540; plus thoracic irradiation using 
megavoltage photon equipment with peak energies of 6 MeV.  Standard 
fractionation schedule.
Arm II:  2-Drug Combination Chemotherapy plus Radiotherapy.  CACP; VP-16; plus 
thoracic irradiation with equipment as in Arm I.  Hyperfractionated schedule.
Regimen A:  Radiotherapy.  PCI using any megavoltage photon equipment.

Published Results

Yuen AR, Zou G, Turrisi AT, et al.: Similar outcome of elderly patients in intergroup trial 0096: Cisplatin, etoposide, and thoracic radiotherapy administered once or twice daily in limited stage small cell lung carcinoma. Cancer 89 (9): 1953-60, 2000.[PUBMED Abstract]

Turrisi AT 3rd, Kim K, Blum R, et al.: Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med 340 (4): 265-71, 1999.[PUBMED Abstract]

Yuen A, Zou G, Turrisi A, et al.: Similar outcome of elderly patients in Intergroup trial 0096: cisplatin (P), etoposide (E), and thoracic radiotherapy (TRT) administered once (QD) or twice daily (BID) in limited stage small cell lung cancer (SCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 18: A1803, 467a, 1999.

Aisner SC, Turrisi A, Kim KM, et al.: Incidence and clinical significance of variant morphology (small cell/large cell subtype) in limited stage small cell lung cancer (SCLC). A prospective analysis of an intergroup ECOG, RTOG, and SWOG study. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1764, 458a, 1998.

Turrisi A, Kim K, Sause W, et al.: Observations after 5 year follow-up of intergroup trial 0096: 4 cycles of cisplatin (P) etoposide (E) and concurrent 45 GY thoracic radiotherapy by 25 GY PCI. Survival differences and patterns of failure . [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1757, 457a, 1998.

Johnson DH, Kim K, Sause W, et al.: Cisplatin (P) & etoposide (E) + thoracic radiotherapy (TRT) administered once or twice daily (BID) in limited stage (LS) small cell lung cancer (SCLC): final report of intergroup trial 0096. [Abstract] Proceedings of the American Society of Clinical Oncology 15: A-1113, 374, 1996.

Johnson DH, Kim K, Turrisi AT, et al.: Cisplatin (P) & etoposide (E) + concurrent thoracic radiotherapy (TRT) administered once versus twice daily for limited-stage (LS) small cell lung cancer (SCLC): preliminary results of an intergroup trial. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1105, 333, 1994.

Johnson DH, Kim K, Turrisi AT, et al.: Cisplatin (P) and etoposide (E) + concurrent thoracic radiotherapy (TRT) administered once vs twice daily for limited-stage (LS) small cell lung cancer (SCLC): preliminary results of an intergroup trial. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1105, 1994.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

David Johnson, MD, Protocol chair
Ph: 615-343-9454; 800-811-8480
Email: david.h.johnson@vanderbilt.edu

Radiation Therapy Oncology Group

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

Southwest Oncology Group

Robert Livingston, MD, Protocol chair (Contact information may not be current)
Ph: 206-288-2034

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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