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A Pilot Study of Stereotactic Body Radiation Therapy (SBRT) After TEMLA for Stage III and IV (Oligometastatic) Non-Small Cell Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

A Pilot Study of Stereotactic Body Radiation Therapy (SBRT) After TEMLA for Stage III and IV (Oligometastatic) Non-Small Cell Lung Cancer


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).

OUTLINE:

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

After completion of study treatment, patients are followed up at 6, 9, and 12 months, and
then every 6 months for 4 years.


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])

- Prior chemotherapy is allowed

- 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 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

- Patient has had open thoracotomy for lung cancer

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4

Outcome Description:

Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.

Outcome Time Frame:

Up to 5 years

Safety Issue:

Yes

Principal Investigator

Anurag Singh

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

I 223812

NCT ID:

NCT01781741

Start Date:

March 2013

Completion Date:

Related Keywords:

  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263