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Trial record 1 of 1 for:    NCT01781741
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Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Stage III-IV Non-small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01781741
First received: January 30, 2013
Last updated: July 24, 2017
Last verified: July 2017
January 30, 2013
July 24, 2017
March 6, 2013
November 30, 2015   (Final data collection date for primary outcome measure)
Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 3 years ]
Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.
Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: Up to 5 years ]
Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.
Complete list of historical versions of study NCT01781741 on ClinicalTrials.gov Archive Site
  • Time until chemotherapy [ Time Frame: From the date of SBRT completion until the date of chemotherapy initiation, assessed up to 5 years ]
    A 90% confidence interval will be presented.
  • Incidence of toxicity associated with combining TEMLA with or without minimally invasive surgery stratified by chemotherapy regimens [ Time Frame: Up to 5 years ]
    Exact 90% confidence intervals will be obtained for each unique chemotherapy regimen. Will be compared at each time-point between tumor locations using the Fisher's exact test.
  • Overall survival [ Time Frame: From SBRT completion until death, assessed up to 5 years ]
    Will be described using standard Kaplan-Meier methodologies. The median survival time, 3-year survival rate, and 5-year survival rate and will be estimated and presented with 90% confidence intervals.
  • Quality of life (QoL) scores from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ Lung Cancer-Specific Module [ Time Frame: Up to 5 years ]
    Will be compared with cumulative toxicity rates at each time-point between tumor locations using the Mann-Whitney U test. Comparisons of QoL scores between time-points will be made using the Wilcoxon signed rank test.
  • Time until chemotherapy [ Time Frame: From the date of SBRT completion until the date of chemotherapy initiation, assessed up to 5 years ]
    A 90% confidence interval will be presented.
  • Incidence of toxicity associated with combining TEMLA with or without minimally invasive surgery stratified by chemotherapy regimens [ Time Frame: Up to 5 years ]
    Exact 90% confidence intervals will be obtained for each unique chemotherapy regimen. Will be compared at each time-point between tumor locations using the Fisher's exact test.
  • Overall survival (OS) [ Time Frame: From SBRT completion until death, assessed up to 5 years ]
    Will be described using standard Kaplan-Meier methodologies. The median survival time, 3-year survival rate, and 5-year survival rate and will be estimated and presented with 90% confidence intervals.
  • Quality of life (QoL) scores from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ Lung Cancer-Specific Module [ Time Frame: Up to 5 years ]
    Will be compared with cumulative toxicity rates at each time-point between tumor locations using the Mann-Whitney U test. Comparisons of QoL scores between time-points will be made using the Wilcoxon signed rank test.
Not Provided
Not Provided
 
Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
A Pilot Study of Stereotactic Body Radiation Therapy (SBRT) After TEMLA With or Without Minimally Invasive Surgery for Stage III and Stage IV (Oligometastatic) Non-small Cell Lung Cancer
This pilot clinical trial studies stereotactic body radiation therapy after surgery in treating patients with stage III-IV non-small cell lung cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with non-small cell lung cancer. Giving stereotactic body radiation therapy after lymphadenectomy may kill any tumor cells that remain after surgery.

PRIMARY OBJECTIVES:

I. To assess the feasibility/toxicity of combining transcervical extended mediastinal lymphadenectomy (TEMLA) with or without video-assisted thoracoscopic surgery (VATS) and stereotactic body radiation therapy (SBRT).

SECONDARY OBJECTIVES:

I. To assess time to initiation of chemotherapy following TEMLA with or without video-assisted thoracoscopic surgery (VATS)and SBRT.

II. To assess feasibility/toxicity of combining TEMLA with or without VATS and SBRT with various chemotherapy regimens (to be determined by medical oncologist based on patient and tumor characteristics).

III. To estimate survival following TEMLA with or without VATS and SBRT. IV. To define any differences in quality of life/toxicity following TEMLA with or without VATS and SBRT based on tumor location (peripheral/central).

V. To assess response for primary tumor control and overall survival in TEMLA only patients.

VI. To assess progression free survival for TEMLA with or without (VATS) patients.

OUTLINE:

Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without VATS.

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

Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Recurrent Non-small Cell Lung Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Combination Product: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT)
    Undergo TEMLA and SBRT
  • Other: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
Experimental: Treatment (TEMLA and SBRT)
Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without minimally invasive surgery.
Interventions:
  • Combination Product: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT)
  • Other: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
November 30, 2017
November 30, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Have histologically proven diagnosis of non-small cell lung cancer (NSCLC) (stage III and stage IV [to include limited volume metastases such as brain, bone, adrenal])
  • Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
  • Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving and study related procedure
  • Patients with chemotherapy prior to TEMLA are eligible

Exclusion Criteria:

  • Contraindication to SBRT or TEMLA; this includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breathe reproducibly
  • If patient has an open thoracotomy for lung cancer they will not be able to receive SBRT and will be replaced
  • Pregnant or nursing female patients
  • Unwilling or unable to follow protocol requirements
  • Any condition which the investigator's opinion deems the patient ineligible
  • Received an investigational agent within 30 days prior to enrollment
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01781741
I 223812
NCI-2013-00055 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 223812 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Anurag Singh Roswell Park Cancer Institute
Roswell Park Cancer Institute
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP