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NCT00005062 · CITED IN SOURCE DOCUMENTS

Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2014-03-13

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain. PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically proven limited stage small cell lung cancer * Complete response to induction therapy (at least on chest x-ray) * Normal brain CT scan or MRI less than 1 month prior to study * No metastases (including ipsilateral lung metastases and malignant pleural effusion) PATIENT CHARACTERISTICS: Age: * 70 and under Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No prior cerebrovascular disease Other: * No epilepsy requiring permanent oral medication * No other prior malignancy except skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No concurrent chemotherapy Endocrine therapy: * Concurrent steroids allowed Radiotherapy: * Concurrent thoracic radiotherapy allowed Surgery: * Not specified Other * No other concurrent antitumoral agent
healthy Volunteers
false
maximum Age
70 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
EnrollmentSource null
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Incidence of brain metastases 2 years after randomization
secondary Outcomes
  1. measure
    Overall survival and disease-free survival 2 years after randomization
  2. measure
    Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter
  3. measure
    Treatment late sequelae as assessed by Late Effect of Normal Tissue - Subjective Objective Management Analytic scale, brain CT scan, or MRI before randomization and then annually thereafter
Full study description
brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain. PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.
detailed Description
OBJECTIVES: * Compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of the incidence of brain metastases and overall and disease free survival at 2 years in patients with limited stage small cell lung cancer in complete remission. * Evaluate the quality of life and late sequelae in this patient population treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and interval between the start of induction therapy and date of randomization (90 days or less vs 91-180 days vs more than 180 days). Patients are randomized into one of two treatment arms according to the prophylactic cranial radiotherapy dose. * Arm I: Patients receive standard-dose prophylactic cranial radiotherapy (10 fractions/12 days). * Arm II: Patients receive high-dose prophylactic cranial radiotherapy administered over 16 or 24 days based on the choice of their treatment center. * 18 fractions/24 days (conventional radiotherapy) OR * 24 fractions/16 days (accelerated hyperfractionated radiotherapy) Patients with isolated brain failure may undergo further radiotherapy. Quality of life is assessed prior to randomization, at 6 months, at 1 year, and then annually thereafter. Patients are followed at least every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study within 3 years.
Source references
references
  1. citation
    Le Pechoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; 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 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20.
    pmid
    19386548
    type
    BACKGROUND
  2. citation
    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.
    type
    BACKGROUND
  3. citation
    Le Pechoux C, Laplanche A, Faivre-Finn C, Ciuleanu T, Wanders R, Lerouge D, Keus R, Hatton M, Videtic GM, Senan S, Wolfson A, Jones R, Arriagada R, Quoix E, Dunant A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Clinical neurological outcome and quality of life among patients with limited small-cell cancer treated with two different doses of prophylactic cranial irradiation in the intergroup phase III trial (PCI99-01, EORTC 22003-08004, RTOG 0212 and IFCT 99-01). Ann Oncol. 2011 May;22(5):1154-1163. doi: 10.1093/annonc/mdq576. Epub 2010 Dec 7.
    pmid
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    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        p;version=HealthProfessional&amp;language=English'); return(false);">Level of evidence A1</a>]</li><li>The randomized RTOG-0212 study (<a href="/clinicaltrials/NCT00005062">NCT00005062</a>) included 720 patients with LD SCLC in complete remission after chemoradiation therapy. The trial demonstrated that standard-dose PCI (25 Gy i
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        lthProfessional&amp;language=English'); return(false);">Level of evidence A1</a>]</li><li>The randomized RTOG-0212 study (<a href="/clinicaltrials/NCT00005062">NCT00005062</a>) included 720 patients with LD SCLC in complete remission after chemoradiation therapy. The trial demonstrated that standard-dose PCI (25 Gy in 10 fraction
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        nd less toxic than, higher doses of brain radiation.[<a href="#cit/section_5.33">33</a>]</li><li>Randomized trials such as RTOG-0212 (<a href="/clinicaltrials/NCT00005062">NCT00005062</a>) showed that doses higher than 25 Gy in 10 daily fractions do not improve long-term survival.[<a href="#cit/section_5.33">33</a>-<a href="#c
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      4. context exact
        than, higher doses of brain radiation.[<a href="#cit/section_5.33">33</a>]</li><li>Randomized trials such as RTOG-0212 (<a href="/clinicaltrials/NCT00005062">NCT00005062</a>) showed that doses higher than 25 Gy in 10 daily fractions do not improve long-term survival.[<a href="#cit/section_5.33">33</a>-<a href="#cit/section_5.
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      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice