A Phase 1 interventional study of accelerated conformational radiotherapy in Lung Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-14.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 1, Interventional, and Treatment
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 39 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
No metastatic disease or hilar or mediastinal lymphadenopathy
Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
Poor surgical risk, as defined by 1 of the following:
Pulmonary dysfunction indicated by one or more of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Other:
Chemotherapy:
Radiotherapy:
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
Radiation: accelerated conformational radiotherapy
Overall survival
Time frame: Up to 5 years
Failure-free survival
Time frame: Up to 5 years
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology