Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Induced Oligometastatic Disease
This trial is active, not recruiting.
|Treatments||no lct, lct|
|Sponsor||M.D. Anderson Cancer Center|
|Start date||November 2012|
|End date||November 2019|
|Trial size||94 participants|
|Trial identifier||NCT01725165, 2012-0618, NCI-2012-02874|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Progression-Free Survival (PFS)
time frame: 4 months
Male or female participants at least 18 years old.
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, afatinib, or gefitinib 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, afatinib, or gefitinib 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. 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 prior to randomization, 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.
|Official title||A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Induced Oligometastatic Disease|
|Principal investigator||Daniel Gomez, MD|
|Description||In order to be eligible for this study, you will either be scheduled to receive or have already received induction chemotherapy without the disease getting worse. Study Groups: If the disease has gotten worse after induction chemotherapy, you will no longer be eligible to participate in this study and the study doctor will talk to you about other options. If the disease has not gotten worse after you have completed induction chemotherapy, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups: Group 1 will immediately 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 receive delayed or no LCT after induction chemotherapy. The treatment you receive will depend on what the study doctor thinks is in your best interest. Group 1 - Immediate Local Consolidation Therapy (LCT): Each study cycle is approximately 8 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 - Delayed/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 approximately 8 weeks, but may vary if your doctor thinks it is in your best interest. If you receive chemotherapy, either after 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 may 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 who are eligible to be randomized will be enrolled in this study. Up to 85 of these patients will be enrolled at MD Anderson.|
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