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A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Oligometastatic Disease


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Oligometastatic Disease


In order to be eligible for this study, you will have already received 4-6 cycles of
induction chemotherapy with platinum doublet chemotherapy (such as carboplatin and
paclitaxel), erlotinib (for patients with known epidermal growth factor receptor (EGFR)
mutations), or crizotinib (for patients with known EML4-ALK fusion) without the disease
getting worse.

Study Groups:

You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:

Group 1 will receive local consolidation therapy (LCT) after induction chemotherapy. LCT is
radiation, surgery, or both. If you are assigned to the LCT group, the study doctor will
decide if you will have radiation alone, surgery alone, or radiation combined with surgery.

Group 2 will not receive LCT after induction chemotherapy. The treatment you receive will
depend on what the study doctor thinks is in your best interest.

Group 1 - Local Consolidation Therapy (LCT):

Each study cycle is 6 weeks, but may vary if your doctor thinks it is in your best interest.

Surgery:

You will be given a separate consent form to sign that describes the surgical procedure and
its risks in more detail. The type of surgery you will have will depend on the status of
the disease.

Radiation Therapy:

About 1-2 weeks before you begin radiation therapy, you will have a procedure called a
simulation. During the simulation, the exact location for the radiation therapy will be
planned. The simulation procedure takes about 1 hour.

You will receive radiation daily (Monday through Friday) for a period lasting from 1 day up
to 8 weeks, depending on the location and status of the disease. The radiation only takes a
few minutes to administer each day. However, you will be asked to allow about 1 hour each
day for the procedure.

You will be given a separate consent form to sign that describes the radiation therapy and
its risks in more detail. The type of radiation therapy you will have will depend on the
status of the disease.

Group 2 - No Local Consolidation Therapy (LCT):

If you are in Group 2, you will not be receiving surgery or radiation therapy right after
induction chemotherapy. If you are randomized to this arm, you will receive either systemic
therapy (i.e. chemotherapy) or observation. The care you receive will depend on what your
doctor thinks is in your best interest.

Chemotherapy:

Each study cycle is 6 weeks, but may vary if your doctor thinks it is in your best interest.

If you receive chemotherapy, either after your 4-6 cycles of induction chemotherapy is
complete or after receiving LCT, your treating physician will decide the type of
chemotherapy you will receive.

You will be given a separate consent form to sign that describes the chemotherapy and its
risks in more detail. The type of chemotherapy you will have will depend on the status of
the disease.

Study Visits:

If the study doctor thinks it is needed, the following tests and procedures may be performed
before and/or during chemotherapy and/or radiation

- A physical exam will be performed, including measurement of your vital signs.

- Your performance status will be recorded.

- Your medical history will be recorded.

- You will be asked about any side effects you may be having.

- Blood (about 2 teaspoons) will be drawn for routine tests.

During chemotherapy, if the study doctor thinks it is needed, you may also have a computed
tomography (CT) scan, positron emission tomography (PET) scan, and/or magnetic resonance
imaging (MRI) scan to check the status of the disease. These imaging scans will be done
about every 6-8 weeks during the first year of the study to check the status of the disease.

Length of Treatment:

You may continue receiving the study treatment for up to 2 years or as long as the doctor
thinks it is in your best interest. You will no longer be able to receive the study
treatment if the disease gets worse, if intolerable side effects occur, or if you are unable
to follow study directions.

Your participation on the study will be over after the follow-up visits.

Follow-Up Visits:

All study participants will have follow-up visits after the surgery is complete, or after
the last dose of radiation or chemotherapy, depending on which treatment you were assigned
to. During each follow-up visit, you may have the following tests and procedures performed
if the study doctor thinks it is needed:

- You will have a physical exam, including measurement of your vital signs (blood
pressure, heart rate, temperature, and breathing rate).

- Your performance status will be recorded.

- Your medical history will be recorded.

- You will be asked about any side effects you may be having.

- You will have lung function tests to check the status of the disease.

- You will have a CT scan to check the status of the disease.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- Your oxygen level will be measured using a small device that is placed on the tip of
your finger.

Other Information:

If at any time while you are on study your treating physician thinks it is in your best
interest, you may be switched to the other treatment option (LCT to no LCT or vice versa).

This is an investigational study. The combination of LCT after chemotherapy for the
treatment of NSCLC is being used for research purposes only.

Up to 94 patients will take part in this study. Up to 55 will be enrolled at MD Anderson.


Inclusion Criteria:



1. 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. Prior chemotherapy is allowed.

3. The patient must have received standard first-line therapy defined here as: 4-6
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 is also an acceptable regimen. For patients with known EML4-ALK fusions,
crizotinib for >/=3 months is also an acceptable option. It is not mandatory to check
EGFR mutation or EML4-ALK status prior to entry. The initial 4-6 cycles of
chemotherapy or >/=3 months of erlotinib or crizotinib must be completed within 12
weeks of enrollment.

4. After 3 weeks of completion of initial first line therapy there must be metastatic lesions and no evidence of disease progression based on response
evaluation criteria in solid tumors (RECIST) criteria . a) The metastatic lesions
will be counted as follows: 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. All patients must have a diagnosis of stage AJCC 7th Edition Stage IV
NSCLC. b) The following imaging studies are suggested after first-line therapy to
assess the number of sites: magnetic resonance imaging (MRI) of brain and a positron
emission tomography/computed tomography (PET/CT) scan or a CT scan of the
chest/abdomen/pelvis with contrast. Other studies, such as a bone scan, and
aspiration of pleural fluid, are at the treating physician's discretion.

5. The patient's Eastern Cooperative Oncology Group (ECOG) performance status is at study entry.

6. The patient has adequate hematologic function as defined by an absolute neutrophil
count (ANC) >/= 1,500/mm^3, platelet count >/= 100,000/mm^3, white blood cell count
(WBC) >/= 3,000/ mm^3, and hemoglobin >/= 9 g/dL.

7. The patient has adequate hepatic function as defined by a total bilirubin level 1.5 X the upper limit of normal (Serum bilirubin >/= 1.5x Upper Limit of Normal in
the setting of known Gilbert's disease is allowed), and alkaline phosphatase, AST and
ALT are present.

8. 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.

9. 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)

10. Bevacizumab will not be permitted within 2 weeks of the initiation of the radiation
therapy course

11. Up-front treatment to central nervous system lesions, such as the brain or spine
(prior to first line systemic therapy) 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.

12. The patient is >/= 18 years of age.

13. The patient has signed informed consent.

14. 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. 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. Life expectancy
4. patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.

5. Presence of significant third space fluid which cannot be controlled by drainage.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

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.

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Daniel Gomez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-0618

NCT ID:

NCT01725165

Start Date:

November 2012

Completion Date:

Related Keywords:

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

Name

Location

University of ColoradoDenver, Colorado  80217
University of ChicagoChicago, Illinois  60637
UT MD Anderson Cancer CenterHouston, Texas  77030