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 currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01781741
First received: January 30, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
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
Procedure: therapeutic lymphadenectomy
Radiation: stereotactic radiosurgery
Other: quality-of-life assessment

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.


Secondary Outcome Measures:
  • Time until chemotherapy [ Time Frame: From the date of SBRT completion until the date of chemotherapy initiation, assessed up to 3 years ] [ Designated as safety issue: No ]
    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 3 years ] [ Designated as safety issue: Yes ]
    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 3 years ] [ Designated as safety issue: No ]
    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 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 33
Study Start Date: March 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: therapeutic lymphadenectomy
Undergo TEMLA
Radiation: stereotactic radiosurgery
Undergo SBRT
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the feasibility/toxicity of combining transcervical extended mediastinal lymphadenectomy (TEMLA) with or without minimally invasive surgery and stereotactic body radiation therapy (SBRT).

SECONDARY OBJECTIVES:

I. To assess time to initiation of chemotherapy following TEMLA with or without minimally invasive surgery and SBRT.

II. To assess feasibility/toxicity of combining TEMLA with or without minimally invasive surgery 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 minimally invasive surgery and SBRT.

IV. To define any differences in quality of life/toxicity following TEMLA with or without minimally invasive surgery 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/video-assisted thoracoscopic surgery (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 minimally invasive surgery.

After completion of study treatment, patients are followed up for 3 years and then annually thereafter.

  Eligibility

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

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])
  • If a level 9 was involved and an alternative minimally invasive surgical procedure is possible, then the patient is eligible; this will be at the discretion of the principal investigator
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781741

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: Anurag K. Singh         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Anurag Singh Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01781741     History of Changes
Other Study ID Numbers: I 223812, NCI-2013-00055, I 223812, P30CA016056
Study First Received: January 30, 2013
Last Updated: August 14, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014