Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer - Full Text View

Purpose

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer.

PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Radiation: prophylactic cranial irradiation Radiation: selective external radiation therapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)

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:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of treatment-related adverse events [ Designated as safety issue: Yes ]
Patterns of failure [ Designated as safety issue: No ]
Comparison of time to first failure [ Designated as safety issue: No ]
Evaluation of the percentage of the planned radiotherapy dose to each site [ Designated as safety issue: No ]

Estimated Enrollment:	154
Study Start Date:	March 2010
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.	Radiation: prophylactic cranial irradiation Given 5 days per week for 2 weeks
Experimental: Arm II Patients undergo prophylactic cranial irradiation as in arm I. Patients also undergo consolidative extracranial radiotherapy to locoregional and residual metastatic disease 5 days per week for 2-3 weeks.	Radiation: prophylactic cranial irradiation Given 5 days per week for 2 weeks Radiation: selective external radiation therapy Given 5 days per week for 2-3 weeks

Detailed Description:

OBJECTIVES:

Primary

To compare the 1-year overall median survival rate in patients with extensive stage small cell lung cancer treated with prophylactic cranial irradiation with vs without consolidative extracranial radiotherapy following platinum-based chemotherapy.

Secondary

To compare treatment-related adverse events in these patients.
To evaluate patterns of failure in these patients.
To compare the time to first failure in these patients.
To evaluate the percentage of the planned radiotherapy dose given to each site.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment (complete response vs partial response) and number of metastatic lesions (1 vs 2-3). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.
Arm II: Patients undergo prophylactic cranial irradiation as in arm I. Patients also undergo consolidative extracranial radiotherapy to locoregional and residual metastatic disease 5 days per week for 2-3 weeks.

After completion of study treatment, patients are followed up at 2 weeks; at 1, 2, 6, 9, and 12 months; every 6 months for 2 years; and then annually thereafter.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC) diagnosed within the past 6 months*
- Has 1-4 extracranial metastatic lesions NOTE: *Diagnosis made before treatment with chemotherapy
Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND meets the following criteria:
- Radiographic partial or complete response to chemotherapy in ≥ 1 site of disease according to RECIST criteria (if radiotherapy has been delivered to primary disease with chemotherapy, there must be complete or partial response in ≥ 1 of the sites that has not been treated with radiotherapy)
- No progression in any site
No limited stage SCLC, even if disease progressed
No brain or CNS metastases

PATIENT CHARACTERISTICS:

Zubrod performance status 0-2
ANC ≥ 1,000/mm^3
Platelets ≥ 75,000/mm^3
Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention is allowed)
Serum ALT and AST ≤ 2.5 times upper limit of normal (ULN) (for patients who will receive radiotherapy to the liver)
Serum bilirubin < 1.5 times ULN (for patients who will receive radiotherapy to the liver)
Serum creatinine < 1.5 times ULN (for patients who will receive radiotherapy to the kidneys)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No severe, active co-morbidity, defined as any of the following:
- Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study registration

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior chemotherapy (i.e., toxicities ≤ grade 1 [except for neuropathy and alopecia])
Thoracic radiotherapy administered concurrently with or before chemotherapy for the current diagnosis allowed (these patients will not receive mediastinal radiotherapy per protocol)
No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
No concurrent chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055197

Show 115 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Elizabeth M. Gore, MD

Medical College of Wisconsin

More Information

Additional Information:

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

No publications provided

Responsible Party:	Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT01055197 History of Changes
Other Study ID Numbers:	CDR0000663959, RTOG-0937
Study First Received:	January 22, 2010
Last Updated:	September 26, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

extensive 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 June 17, 2013