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Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
This study has been completed.

First Received on April 7, 2003.   Last Updated on October 11, 2011   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00057746
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer.

PURPOSE: This randomized phase II/III trial is studying how well brain irradiation works and compares three different brain irradiation regimens in preventing brain metastases in patients with limited-stage small cell lung cancer.


Condition Intervention Phase
Lung Cancer
 Radiation: radiation therapy
 Phase II
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase II/III Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Incidence of brain metastases (Phase III patients enrolled before 12/31/05) [ Designated as safety issue: No ]
  • Overall survival (Phase III patients enrolled before 12/31/05) [ Designated as safety issue: No ]
  • Disease-free survival (Phase III patients enrolled before 12/31/05) [ Designated as safety issue: No ]
  • Quality of life (Phase III patients enrolled before 12/31/05) [ Designated as safety issue: No ]
  • LENT-SOMA (Phase III patients enrolled before 12/31/05) [ Designated as safety issue: Yes ]
  • Incidence of chronic neurotoxicity (Phase II patients enrolled after 12/31/05) [ Designated as safety issue: Yes ]
  • Quality of life (Phase II patients enrolled after 12/31/05) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of chronic neurotoxicity (Phase II patients enrolled before 12/31/05) [ Designated as safety issue: Yes ]
  • Quality of life (Phase II patients enrolled before 12/31/05) [ Designated as safety issue: No ]

Estimated Enrollment: 264
Study Start Date: February 2003
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week for 2 weeks.
 Radiation: radiation therapy
Given once or twice daily
Experimental: Arm II
Patients undergo PCI once daily 5 days a week for 2.6 weeks.
 Radiation: radiation therapy
Given once or twice daily
Experimental: Arm III
Patients undergo PCI at a lower dose per fraction than in arm II twice daily 5 days a week for 3.4 weeks.
 Radiation: radiation therapy
Given once or twice daily

Detailed Description:

OBJECTIVES:

  • Compare the incidence of brain metastases in patients with limited stage small cell lung cancer treated with different regimens of prophylactic cranial irradiation. (phase III closed to accrual as of 12/31/05)
  • Compare the overall and disease-free survival of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)
  • Compare the incidence of chronic neurotoxicity in patients treated with these regimens.
  • Compare quality of life and late treatment sequelae of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week. Treatment continues for 2 weeks in the absence of unacceptable toxicity.
  • Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity.
  • Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years.

Patients are followed every 6 months for 1 year and then annually for 3 years.

PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa

    • Limited stage (I-IIIB)

      • Confined to 1 hemithorax
      • No T4 or N3 disease
  • Complete response after induction chemotherapy (with or without thoracic radiotherapy)
  • Consolidative chest radiotherapy may be initiated before study

  • No radiographic evidence of any of the following:

    • Brain metastases

      • Normal brain CT scan or MRI less than 1 month before study
    • Ipsilateral lung metastases

    • Malignant pleural effusion

      • Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 10.0 g/dL^

Hepatic

  • Not specified

Renal

  • Not specified

Pulmonary

  • See Disease Characteristics

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Neurological function class 1 or 2
  • No epilepsy requiring permanent oral medication
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other serious medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • At least 1 week since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
  • Concurrent thoracic radiotherapy allowed

Surgery

  • Not specified

Other

  • No concurrent antitumor agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057746

  Show 222 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Aaron H. Wolfson, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Wolfson AH, Bae K, Komaki R, Meyers C, Movsas B, Le Pechoux C, Werner-Wasik M, Videtic GM, Garces YI, Choy H. Primary Analysis of a Phase II Randomized Trial Radiation Therapy Oncology Group (RTOG) 0212: Impact of Different Total Doses and Schedules of Prophylactic Cranial Irradiation on Chronic Neurotoxicity and Quality of Life for Patients with Limited-Disease Small-Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2010 Aug 26; [Epub ahead of print]
Le Péchoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; on behalf of the Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 Apr 20; [Epub ahead of print]
Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.

Responsible Party: Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00057746     History of Changes
Other Study ID Numbers: CDR0000258668, RTOG-0212
Study First Received: April 7, 2003
Last Updated: October 11, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012



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