Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT02045446
First received: January 14, 2014
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 6 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to maintenance chemotherapy alone.


Condition Intervention Phase
Stage IV Non-Small Cell Lung Cancer
Radiation: Stereotactic Body Radiation Therapy
Drug: Maintenance chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Evaluate the effect of SBRT with or without maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival


Secondary Outcome Measures:
  • Actuarial rate in-field local control [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To describe the actuarial rate in-field local control and rate of out-of-field disease progression

  • Toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To evaluate the safety of SBRT with metastatic NSCLC after prior chemotherapy

  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To evaluate overall survival after SBRT followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.

  • Duration of maintenance chemotherapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To evaluate the duration of maintenance chemotherapy and time to initiation of third line systemic agent (chemotherapy or biologic agent)


Estimated Enrollment: 36
Study Start Date: February 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Maintenance chemotherapy
FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed
Drug: Maintenance chemotherapy
Maintenance chemotherapy
Other Name: Maintenance chemotherapy
Experimental: Stereotactic Body Radiation Therapy
consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy
Radiation: Stereotactic Body Radiation Therapy
Other Name: SBRT
Drug: Maintenance chemotherapy
Maintenance chemotherapy
Other Name: Maintenance chemotherapy

Detailed Description:

This protocol is a randomized phase II trial of maintenance chemotherapy versus consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy for patients with Stage IV non-small cell lung cancer (NSCLC).

Prior to accrual on the trial, patients with Stage IV NSCLC will be treated with standard first-line chemotherapy. Patients who achieve a partial response or stable disease by imaging criteria with fewer than or equal to six sites of oligometastatic disease will be randomized to maintenance chemotherapy or consolidative SBRT to all sites of disease (followed by maintenance chemotherapy at the medical oncologist's discretion). Choices of first line and maintenance chemotherapy will be determined by the medical oncologist based on clinical appropriateness.

  Eligibility

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

Inclusion Criteria:

  1. Patients must have biopsy proven metastatic NSCLC (Stage IV).
  2. Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
  3. Patients receiving first-line erlotinib, gefitinib, or crizotinib for EGFR mutant-positive or EML4-ALK positive NSCLC will be excluded.
  4. Age ≥ 18 years
  5. Patients must have measurable disease at baseline.
  6. Patients can have up to only 6 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by PET scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of SBRT.

    1. For patients who have received prior radiotherapy to the primary site in the lung, residual PET activity is difficult to interpret and will not be considered a site of active disease if the CT appearance is stable or improved over an interval of at least three months
    2. Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
    3. Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply.
    4. Up to 2 contiguous vertebral metastases will be considered a single site of disease.
  7. Patients must have a KPS >60
  8. AST, ALT & Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.
  9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
  10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
  11. Females of childbearing potential should have a negative pregnancy test.
  12. Patients who would be receiving SBRT for lung tumors who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
  13. Patients must provide verbal and written informed consent to participate in the study.
  14. Total bilirubin: within normal institutional limits

Exclusion Criteria:

  1. Patients who previously received radiotherapy to the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy.
  2. Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
  3. Patients with serious, uncontrolled, concurrent infection(s).
  4. Significant weight loss (>10%) in the prior 3 months.
  5. Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
  6. Patients with cutaneous metastasis of NSCLC.
  7. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
  8. Patients with more than 6 discrete extra-cranial lesions.
  9. Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
  10. Unwillingness to participate or inability to comply with the protocol for the duration of the study.
  11. Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study
  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: NCT02045446

Contacts
Contact: Puneeth Iyengar, MD 214-645-8525
Contact: Jean Wu, MSN 214-645-8525

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Principal Investigator: Puneeth Iyengar, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Puneeth Iyengar, MD UTSW
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02045446     History of Changes
Other Study ID Numbers: STU 092013-070
Study First Received: January 14, 2014
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014