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Radical Treatment of Synchronous Oligometastatic Non-Small Cell Lung Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805530
Recruitment Status : Unknown
Verified March 2017 by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico.
Recruitment status was:  Recruiting
First Posted : June 20, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

Tracking Information
First Submitted Date  ICMJE May 23, 2016
First Posted Date  ICMJE June 20, 2016
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2016)
Overall survival [ Time Frame: From date of diagnosis until the date of death from any cause, assessed up to 100 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radical Treatment of Synchronous Oligometastatic Non-Small Cell Lung Carcinoma
Official Title  ICMJE Radical Treatment of Synchronous Oligometastatic Disease and Primary Tumor in Advanced Non-small Cell Lung Carcinoma (NSCLC)
Brief Summary

Non-small cell lung cancer (NSCLC) is the most frequent neoplasm worldwide and also represents the main cause of cancer death. However, it represents the main cause of death by cancer. The prognosis of survival at 5 years is poor, approximately 13-15%.

Various studies suggest that patients who clinically present with a limited number of metastases, a term defined as oligometastatic disease, could have a better prognosis of survival with a radical treatment, than for their counterparts with a greater number of metastasis.

The purpose of this study is to add more information to the current medical literature about the benefits in overall survival of radical treatment of oligometastatic disease in patients with NSCLC and equal or less than 5 synchronous metastases at the time of diagnosis.

The outcomes of the study are to determine the global survival and progression-free survival in patients with synchronous oligometastatic (equal to or less than 5 sites) advanced NSCLC undergoing radical treatment of all metastatic sites and the primary tumor.

Detailed Description

Non-small cell lung cancer (NSCLC) is the most frequent neoplasm worldwide and also represents the main cause of cancer death. However, it represents the main cause of death by cancer. The prognosis of survival at 5 years is poor, approximately 13-15%.

The timely detection of NSCLC is difficult and the options for curative treatment are limited since the majority of patients are diagnosed in advanced stages. The standard treatment in metastatic disease is cytotoxic chemotherapy with platins (cisplatin or carboplatin) in combination with a third generation drug (vinorelbine, paclitaxel, docetaxel, gemcitabine or pemetrexed). This therapeutic scheme results in response rates between 20-30%, with a mean overall survival between 8-11 months.

In recent years, research in oncology has focused on the development of therapies aimed at molecular targets that control the growth and proliferation of the tumor cell. Various monoclonal antibodies (bevacizumab, cetuximab) and tyrosine kinase inhibitors (erlotinib, gefitinib, afatinib, crizotinib) have been evaluated with this purpose in NSCLC treatment. Clinical studies in advanced NSCLC, using these new drugs with or without chemotherapy, have had favorable results by increasing the progression-free survival and the response rate, without being able to demonstrate to date, a significant improvement in the overall survival.

Various studies suggest that patients who clinically present with a limited number of metastases, a term defined as oligometastatic disease, could have a better prognosis of survival with a radical treatment, than for their counterparts with a greater number of metastasis.

Much of the current medical information on clinical outcomes in oligometastatic disease is based on clinical studies and retrospective case series of institutions. The majority of the reports have included a mix of patients with synchronous and metachronous oligometastatic disease, focusing on the radical treatment of specific sites such as the brain and adrenal glands. These results have been recognized by the European Society for Medical Oncology (ESMO) and have been included in its treatment guidelines for lung cancer (2012). The recommendation states to consider some radical treatment in selected patients with solitary metastases.

There is limited information about the clinical benefits in overall survival in the subgroup of patients with NSCLC that clinically present with synchronous oligometastatic disease and equal to or less than 5 synchronous metastases at the time of diagnosis.

The purpose of this study is to add more information to the current medical literature about the benefits in overall survival of radical treatment of oligometastatic disease in patients with NSCLC and equal to or less than 5 synchronous metastases at the time of diagnosis. The outcomes of the study are to determine the global survival and progression-free survival in patients with synchronous oligometastatic (equal to or less than 5 sites) advanced NSCLC undergoing radical treatment of all metastatic sites and the primary tumor.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

First line systemic treatment Epidermal growth factor receptor (EGFR)-mutated with tyrosine kinase inhibitors (afatinib, erlotinib or gefitinib). Patients without driver mutation duplet of chemotherapy based on platin taking account histologic subtype (Carboplatin or Cisplatin plus pemetrexed for adenocarcinomas, gemcitabine for epidermoid or paclitaxel for both) at discretion of the treating physician.

Radical treatment to the primary and to the metastases will be with surgery, radiotherapy, chemoradiotherapy, stereotactic radiosurgery or radiofrequency ablation.

Radiation: radiation therapy Patients will receive dose and fraction regimen according to the metastatic site.

Chemoradiotherapy Chemoradiotherapy with duplet based on platins (Carboplatin or cisplatin plus pemetrexed or paclitaxel or etoposide or vinorelbine) or monotherapy with carboplatin.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Non-Small-Cell Lung
  • Synchronous Neoplasms
Intervention  ICMJE
  • Other: First line systemic treatment
    Epidermal growth factor receptor (EGFR)-mutated with tyrosine kinase inhibitors (afatinib, erlotinib or gefitinib). Patients without driver mutation duplet of chemotherapy based on platin taking account histologic subtype (Carboplatin or Cisplatin plus pemetrexed for adenocarcinomas, gemcitabine for epidermoid or paclitaxel for both) at discretion of the treating physician.
  • Other: Radical treatment
    to the primary and to the metastases will be with surgery, radiotherapy, chemoradiotherapy, stereotactic radiosurgery or radiofrequency ablation.
  • Radiation: radiation therapy
    Patients will receive dose and fraction regimen according to the metastatic site.
  • Other: Chemoradiotherapy
    Chemoradiotherapy with duplet based on platins (Carboplatin or cisplatin plus pemetrexed or paclitaxel or etoposide or vinorelbine) or monotherapy with carboplatin.
Study Arms  ICMJE Experimental: single arm

Patients with synchronous metastases at Central Nervous System (CNS), evaluated in less than one week by the Multidisciplinary Committee at National Cancer Institute of Mexico to define the initial treatment. Patients with metastases at other sites than CNS will receive first line systemic treatment, in those EGFR-mutated with tyrosine kinase inhibitors (TKI) and in patients without a driver mutation with first line duplet of chemotherapy based on platin. The type of TKI or chemotherapy will be at discretion of the treating physician.

After 4 cycles of treatment, patients with stable disease or partial response will be evaluated by de Multidisciplinary Committee to establish the type of radical treatment to the primary and to the metastases, radiation therapy and chemoradiotherapy.

Interventions:
  • Other: First line systemic treatment
  • Other: Radical treatment
  • Radiation: radiation therapy
  • Other: Chemoradiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 15, 2016)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathology diagnosis of non-small cell lung cancer
  • Any histology type (adenocarcinoma, epidermoid carcinoma or large cell carcinoma)
  • age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) score 0-1
  • Clinical stage IV according to staging system American Joint Committee on Cancer (AJCC) seventh EDITION
  • Oligometastatic disease defined as metastases equal to or less than 5 sites.
  • Synchronous metastases defined as those that are identified within the first month of the diagnosis of the primary tumor.
  • Laboratory results: plasma leukocyte ≥3,000/mm3, platelets ≥100,000/mm3, hemoglobin ≥ 10 gr/dl, serum Creatinine ≤ 1.5 mg/dl, total bilirubin ≤1.5, transaminases ≤ 2.5 times the upper limit of normal (ULN), alkaline phosphatase < 5 times the ULN.
  • Candidate to platinum-based chemotherapy.
  • Life expectancy estimated with treatment of at least 24 weeks.
  • Must have understood and signed the informed consent

Exclusion Criteria:

  • Concurrent uncontrolled diseases
  • Patients with malignant pleural or pericardial effusion.
  • Previous treatments (radiotherapy treatment to the primary site, chemotherapy or treatment with tyrosine kinase inhibitor.)
  • Pregnant or lactating women.
  • Intercurrent malignant diseases, except basal cell carcinoma in skin inactive, carcinoma in situ of the cervix, when completely resected.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02805530
Other Study ID Numbers  ICMJE 015/023/ICI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
Study Sponsor  ICMJE Instituto Nacional de Cancerologia de Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Oscar Arrieta, MD Instituto Nacional de Cancerología
PRS Account Instituto Nacional de Cancerologia de Mexico
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP