Trial record 2 of 14 for:    River PCI

Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00057746
First received: April 7, 2003
Last updated: January 15, 2014
Last verified: January 2014
  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: Prophylactic Cranial Irradiation (PCI)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Incidence of brain metastases (Phase III patients enrolled before 12/31/05) [ Time Frame: From study registration up to 3 years post-treatment. Analysis occurs when each patient has been potentially followed for a minimum of 12 months. ] [ Designated as safety issue: No ]
  • Overall survival (Phase III patients enrolled before 12/31/05) [ Time Frame: From randomization to date of death of last follow-up. Analysis occurs when each patient has been potentially followed for a minimum of 12 months. ] [ Designated as safety issue: No ]
  • Disease-free survival (Phase III patients enrolled before 12/31/05) [ Time Frame: From registration to date of failure (local, regional or distant progression or second primary or death) or last follow-up. Analysis occurs when eact patient has been potentially followed for a minimum of 12 months. ] [ Designated as safety issue: No ]
  • Quality of life (Phase III patients enrolled before 12/31/05) [ Time Frame: From study registration to up 3 years post-treatment. Analysis occurs when eact patient has been potentially followed for a minimum of 12 months. ] [ Designated as safety issue: No ]
  • LENT-SOMA (Phase III patients enrolled before 12/31/05) [ Time Frame: From study registration up to 3 years post-treatment. Analysis occurs when eact patient has been potentially followed for a minimum of 12 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of chronic neurotoxicity (Phase II patients enrolled before 12/31/05) [ Time Frame: From study registration up to 3 years post-treatment. Analysis occurs when each patient has been potentially followed for a minimum of 12 months. ] [ Designated as safety issue: Yes ]
  • Quality of life (Phase II patients enrolled before 12/31/05) [ Time Frame: From study registration up to 3 years post-treatment. Analysis occurs when each patient has been potentially followed for a minimum of 12 months. ] [ Designated as safety issue: No ]

Enrollment: 265
Study Start Date: February 2003
Study Completion Date: November 2013
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: Prophylactic Cranial Irradiation (PCI)
Given once or twice daily
Other Name: PCI
Experimental: Arm II
Patients undergo PCI once daily 5 days a week for 2.6 weeks.
Radiation: Prophylactic Cranial Irradiation (PCI)
Given once or twice daily
Other Name: PCI
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: Prophylactic Cranial Irradiation (PCI)
Given once or twice daily
Other Name: PCI

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057746

  Show 222 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Aaron H. Wolfson, MD University of Miami
  More Information

Additional Information:
Publications:
Gondi V, Paulus R, Bruner D, et al.: Prognostic significance of QOL deterioration during early lung cancer survivorship: secondary analysis of RTOG 0212 and 0214. [Abstract] J Clin Oncol 29 (Suppl 15): A-6061, 2011.
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: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00057746     History of Changes
Other Study ID Numbers: RTOG-0212, CDR0000258668
Study First Received: April 7, 2003
Last Updated: January 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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 July 24, 2014