Oligometastatic Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
University of Chicago
University of Colorado, Denver
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01725165
First received: November 8, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

The goal of this clinical research study is to learn if surgery or radiation after chemotherapy can help to control NSCLC. The safety of this treatment will also be studied.


Condition Intervention Phase
Lung Cancer
Other: No LCT
Other: LCT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Oligometastatic Disease

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) defined as time from the time of randomization (LCT vs. no LCT) to disease progression or death. For the primary endpoint, PFS, Kaplan-Meier estimate will be computed and the log-rank test will be performed to compare the difference of PFS between the two arms.


Estimated Enrollment: 94
Study Start Date: November 2012
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Local Consolidation Therapy (LCT)
Patients receive local consolidation therapy (LCT) after induction chemotherapy. LCT is radiation, surgery, or both. If assigned to the LCT group, the study doctor will decide if patient has radiation alone, surgery alone, or radiation combined with surgery.
Other: LCT

Patients receive local consolidation therapy (LCT) after induction chemotherapy. LCT is radiation, surgery, or both. If assigned to the LCT group, study doctor will decide if patient has radiation alone, surgery alone, or radiation combined with surgery.

Radiation therapy delivered using external beam radiation, with either 2D/conventional techniques, three-dimensional conformal therapy, intensity modulated radiation therapy (IMRT), stereotactic radiosurgery (SRS) or proton beam therapy (PBT), at discretion of treating radiation oncologist.

Surgical control of primary and metastatic sites of disease may include control of either or both sites of disease as determined by multidisciplinary group (medical oncologist, radiation oncologist, and surgeon).

Active Comparator: No Local Consolidation Therapy (LCT)
Patients randomized to the no LCT arm receive maintenance therapy (switch or continuation), or surveillance, based on physician choice after induction chemotherapy. Pemetrexed, bevacizumab, crizotinib (for ALK-mutation positive patients) or erlotinib are recommended as acceptable maintenance agents but other agents may be used at physician discretion.
Other: No LCT
No surgery or radiation therapy right after induction chemotherapy. Patients receive either systemic therapy (i.e. chemotherapy) or observation. The care received will depend on discretion of doctor.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. STEP 1 Enrollment: The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration. Mixed tumors will be categorized by the predominant cell type.
  2. The patient has a diagnosis of American Joint Committee on Cancer (AJCC) 7th Edition stage IV NSCLC.
  3. Three or less metastatic lesions (not sites). * each lesion (including a satellite nodule) will individually be counted as one, and intrathoracic lymph node involvement (defined here as hilar, mediastinal, or supraclavicular nodes, N1-N3) will collectively be counted as one. In addition, patients can receive treatment to CNS lesions or other symptomatic lesions requiring urgent local therapy prior to randomization, but these lesions will be counted towards the total number after chemotherapy, and patients will only be eligible if there are remaining sites amenable to local therapy after up-front systemic therapy.
  4. Standard induction chemotherapy planned defined as: *At least 4 cycles of platinum doublet chemotherapy for metastatic disease (with or without bevacizumab), * if the patient is known to be EGFR mutation positive, erlotinib for >/=3 months, or * for patients with known EML4-ALK fusions, crizotinib for >/=3 months
  5. STEP 2 Enrollment and Randomization: The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration. Mixed tumors will be categorized by the predominant cell type.
  6. The patient has a diagnosis of American Joint Committee on Cancer (AJCC) 7th Edition stage IV NSCLC.
  7. Completion of standard induction chemotherapy planned defined as: *At least 4 cycles of platinum doublet chemotherapy for metastatic disease (with or without bevacizumab), *if the patient is known to be EGFR mutation positive, erlotinib or afatinib for >/=3 months, or *for patients with known EML4-ALK fusions, crizotinib. Note that it is not mandatory to check EGFR mutation or EML4-ALK status prior to entry, but patients that receive options 2 or 3 should have had these molecular tests performed.
  8. Less than or equal to three metastatic lesions and no evidence of disease progression based on RECIST criteria. Note that patients that had >3 metastatic lesions in Step 1 may be eligible for enrollment in Step 2 if the number of metastatic sites is reduced to three or less.
  9. The patient's ECOG performance status is </= 2 at study entry.
  10. The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm^3, platelet count >/= 100,000/mm^3, WBC >/= 3,000/ mm^3, and hemoglobin >/= 9 g/dL within 3 weeks of study entry.
  11. The patient must be a suitable candidate for LCT (radiotherapy and/or surgery) to every site of disease, as determined by the treating physician(s). Consultation with a multidisciplinary team, including a medical oncologist, radiation oncologist, and thoracic surgeon, is encouraged but not required.
  12. Concurrent chemoradiation is permitted as consolidative therapy. The following concurrent therapies are permitted: Tyrosine kinase inhibitors (i.e. erlotinib) - can be delivered with both hypofractionated >/=3 Gy per fraction) and standard fractionated radiation therapy (<3 Gy per fraction); platinum-based chemotherapy - standard fractionated radiation therapy (<3 Gy per fraction)
  13. Bevacizumab will not be permitted within 2 weeks of the initiation of the radiation therapy course
  14. Up-front treatment to central nervous system lesions, such as the brain or spine (prior to first line systemic therapy), or symptomatic lesions requiring urgent palliative radiation, is permitted, in which case the patient would be randomized to treatment of other metastatic sites or the primary sites (based on the disease remaining after first-line treatment). These treated lesions should be counted towards the total number of metastases at the time of enrollment.
  15. The patient is >/= 18 years of age.
  16. The patient has signed informed consent.
  17. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for six (6) months after discontinuation of the study drugs. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation, hysterectomy or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. The patient, if a man, agrees to use effective contraception or abstinence for the duration of study participation and for six (6) months after discontinuation of the study drugs.

Exclusion Criteria:

  1. STEPS 1 and 2 and randomization: The patient has a history of uncontrolled angina, arrhythmias, or congestive heart failure.
  2. Patients with a history of malignant pleural effusions are not eligible. Pleural effusions considered by the investigator too small for a diagnostic thoracentesis are permissible.
  3. patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
  4. Presence of significant third space fluid which cannot be controlled by drainage
  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: NCT01725165

Contacts
Contact: Daniel Gomez, MD 713-563-2300

Locations
United States, Colorado
University of Colorado Not yet recruiting
Denver, Colorado, United States, 80204
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
University of Chicago
University of Colorado, Denver
Investigators
Principal Investigator: Daniel Gomez, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01725165     History of Changes
Other Study ID Numbers: 2012-0618, NCI-2012-02874
Study First Received: November 8, 2012
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Lung cancer
Non-Small Cell Lung Cancer
NSCLC
Oligometastatic Disease
Chemotherapy
Surgical control
primary and metastatic sites of disease
Radiation therapy
external beam radiation
2D/conventional techniques
three-dimensional conformal therapy
intensity modulated radiation therapy
IMRT
stereotactic radiosurgery
SRS
proton beam therapy
PBT

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 August 21, 2014