Radiation Therapy in Treating Patients With Extensive Stage Small Cell

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01055197
Study type	Interventional
Source	Radiation Therapy Oncology Group
Contact
Status	Completed
Phase	Phase 2
Start date	March 2010
Completion date	December 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03918538` - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors	N/A
Recruiting	`NCT05078918` - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors	N/A
Active, not recruiting	`NCT04548830` - Safety of Lung Cryobiopsy in People With Cancer	Phase 2
Completed	`NCT04633850` - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT05583916` - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery	N/A
Completed	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting	`NCT06376253` - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers	Phase 1
Recruiting	`NCT05898594` - Lung Cancer Screening in High-risk Black Women	N/A
Active, not recruiting	`NCT05060432` - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT03575793` - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer	Phase 1/Phase 2
Active, not recruiting	`NCT03667716` - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.	Phase 1
Terminated	`NCT01624090` - Mithramycin for Lung, Esophagus, and Other Chest Cancers	Phase 2
Terminated	`NCT03275688` - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting	`NCT04931420` - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels	Phase 2
Recruiting	`NCT06010862` - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors	Phase 1
Recruiting	`NCT06052449` - Assessing Social Determinants of Health to Increase Cancer Screening	N/A
Not yet recruiting	`NCT06017271` - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting	`NCT05787522` - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk

Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms