Trial record 1 of 1 for:
rtog and 0937
Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
This study is currently recruiting participants.
Verified September 2012 by National Cancer Institute (NCI)
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01055197
First received: January 22, 2010
Last updated: September 26, 2012
Last verified: September 2012
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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:
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
Show 115 Study LocationsSponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
| Principal Investigator: | Elizabeth M. Gore, MD | Medical College of Wisconsin |
More Information
Additional Information:
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 18, 2013