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

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:	Treatment, Randomized, Active Control
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
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week for 2 weeks.	Radiation: radiation therapy Given once or twice daily
Arm II: Experimental Patients undergo PCI once daily 5 days a week for 2.6 weeks.	Radiation: radiation therapy Given once or twice daily
Arm III: Experimental 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 - Miami

More Information

Additional Information:

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

Publications:

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:	Radiation Therapy Oncology Group ( Walter John Curran, Jr )
Study ID Numbers:	CDR0000258668, RTOG-0212
Study First Received:	April 7, 2003
Last Updated:	April 26, 2009
ClinicalTrials.gov Identifier:	NCT00057746 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

limited stage small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Carcinoma, Neuroendocrine
Neoplasms, Nerve Tissue
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009