Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
James J. Urbanic

Description

Summary

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

Official Title

Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial

Details

PRIMARY OBJECTIVES:

Phase II

To evaluate the impact of adding stereotactic body radiation therapy (SBRT) to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic non-small cell lung cancer (NSCLC) with no evidence of progression and limited metastatic sites after first-line systemic therapy.

Phase III

To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy.

SECONDARY OBJECTIVES:

  1. To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure.

II. To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on primary failure.

III. To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on out-of-field disease progression.

IV. To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity.

  1. To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on duration of maintenance systemic chemotherapy usage.

VI. To evaluate the effect of adding SBRT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL)

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM 1 (CHEMOTHERAPY ALONE): Patients may receive docetaxel intravenously (IV) over 60 minutes on Day 1, or gemcitabine IV over 30 minutes on Days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on Day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM 2 (SBRT AND CHEMOTHERAPY): Patients undergo SBRT to all sites of metastases (≤3 discrete sites) plus irradiation of the primary site (SBRT or hypofractionated RT) followed by chemotherapy as in Arm 1.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.

Keywords

Recurrent Non-Small Cell Lung Carcinoma Stage IV Non-Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Gemcitabine Pemetrexed Docetaxel 3-Dimensional Conformal Radiation Therapy (3D-CRT) Intensity-Modulated Radiation Therapy (IMRT) Pemetrexed Disodium Stereotactic Body Radiation Therapy (SBRT)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during the trial
  • Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration; this includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop metastases
  • Appropriate stage for study entry based on the following diagnostic workup:
  • History/physical examination within 30 days prior to registration
  • Imaging proof of limited metastatic disease and response to therapy/stable disease, by at least CT chest through the adrenals or PET/CT within 30 days prior to registration
  • Zubrod performance status 0, 1, or 2 within 30 days prior to registration
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN with metastatic liver disease
  • Total bilirubin ≤ 1.5 × ULN
  • Absolute neutrophil count (ANC) ≥ 500 cells/mm3

  • Creatinine clearance ≥ 45 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

  • Platelets ≥ 50,000 cells/mm3

  • Negative serum pregnancy test within one week prior to registration for females of childbearing potential
  • Patients must have received first-line/induction chemotherapy (4 cycles) and achieved stable disease or a partial response
  • Prior systemic chemotherapy as part of concurrent treatment approach for previously diagnosed stage III NSCLC, as adjuvant therapy for previously resected NSCLC, or for other previous cancers is permitted
  • Prior radiotherapy for patients with brain metastases prior to enrollment is acceptable
  • Patients must have measurable disease at baseline and 3 or fewer discrete,extracranial metastatic disease sites that are technically amenable to SBRT
  • For de novo stage IV NSCLC patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy in the form of SBRT or hypofractionated radiation; if the primary disease is found in the peripheral or central lung parenchyma without nodal disease for instance, SBRT may be employed;if primary disease is more advanced with involvement of the mediastinum (T4 tumor,N1-N3 disease, etc.), these volumes should be technically treatable with hypofractionated radiation
  • If primary disease in the thoracic cavity was previously treated with local therapy in the form of surgery, any local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation after induction systemic therapy
  • Patients must be registered within 35 days of administration of the last dose of first-line/induction systemic therapy
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • Patients with brain metastases are eligible if these lesions have been previously treated and the patients have no clinical or radiographic evidence of progression prior to enrollment

You CAN'T join if...

  • Clinical or radiologic evidence of untreated and/or progressive brain metastases
  • Cutaneous metastasis of NSCLC
  • Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes
  • Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix)unless disease free for a minimum of one year
  • Metastases located within 3 cm of previously irradiated (< 3Gy per fraction)structures if:
  • Spinal cord previously irradiated to > 40 Gy
  • Brachial plexus previously irradiated to > 50 Gy
  • Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
  • Brainstem previously irradiated to > 50 Gy
  • Lung previously irradiated with prior V20 Gy > 35%
  • Patients receiving targeted therapy (non-cytotoxic systemic therapy) for NSCLC in the first-line setting
  • If a patient has progressed in previous areas of primary disease that received definitive doses of radiation, these patients would require re-irradiation in previous high dose anatomic areas and are not eligible for this study
  • Patients with malignant pleural effusions that do not resolve after first-line systemic therapy; patients with pleural effusions that have become too small for thoracentesis at the time of registration would be permitted on study, indicating a significant response to first-line chemotherapy
  • Patients with more than 3 discrete locations of extra-cranial metastatic disease after first-line systemic therapy requiring more than 3 SBRT plans to cover these distinct metastatic disease entities
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Patients who are pregnant or nursing
  • Participation in any investigational drug study (excluding non-oncology and/or symptom management studies) within 4 weeks prior to registration
  • Known human immunodeficiency virus (HIV) positive with cluster of differentiation 4(CD4) count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy(HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Saint Joseph Hospital - Orange accepting new patients
    Orange California 92868 United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte California 91010 United States
  • Los Angeles County-USC Medical Center accepting new patients
    Los Angeles California 90033 United States
  • USC / Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • City of Hope South Pasadena accepting new patients
    South Pasadena California 91030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NRG Oncology
ID
NCT03137771
Phase
Phase 2
Lead Scientist
James J. Urbanic
Study Type
Interventional
Last Updated
April 30, 2018