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Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer.

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119519
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaoxia Zhu, Southern Medical University, China

Brief Summary:
Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in this subset of patients.

Condition or disease Intervention/treatment Phase
Stage IV Non-small Cell Lung Cancer Radiation: Local Definitive Radiotherapy Drug: No Local Definitive Radiotherapy Phase 2

Detailed Description:
For NSCLC patients with synchronous oligometastases, first line chemotherapy or targeted therapy concurrent with non-salvage radiotherapy on metastatic or primary thoracic tumor contributed a longer progression-free survival than chemotherapy or targeted therapy alone.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized phase II trial of first line chemotherapy or targeted therapy plus local definitive radiotherapy or not for patients with synchronous oligometastatic non-small cell lung cancer
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer :A Multicenter,Randomized,Controlled,Phase 2 Study.
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) followed by 3D-CRT (three-dimensional conformal radiotherapy) or IMRT (intensity modulated radiotherapy) to primary thoracic foci or remediable oligometastatic focus.
Radiation: Local Definitive Radiotherapy
three-dimensional conformal therapy or intensity modulated radiation therapy
Other Name: LDR

Drug: No Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
Other Name: Non-LDR

Active Comparator: No Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
Drug: No Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
Other Name: Non-LDR




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 5 years ]
    Refers to the time from randomization to disease progression or death.


Secondary Outcome Measures :
  1. Local tumor control [ Time Frame: up to 5 years ]
    From time of randomization to time of progression or death(according to RECIST v1.1 [)

  2. Oligometastatic foci control [ Time Frame: up to 5 years ]
    From time of first chemotherapy or targeted therapy to time of progression or death(according to RECIST v1.1)

  3. Thoracic Progression Free Survival [ Time Frame: up to 5 years ]
    From time of first chemotherapy or targeted therapy to time of progression or death

  4. Overall Survival [ Time Frame: up to 5 years ]
    From time of first chemotherapy or targeted therapy to date of death



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged 18 to 70 years old;
  2. Histologically or cytologically confirmed non-small cell lung cancer;
  3. Stage IV patients with measurable primary tumor and distant metastases number ≤5;
  4. PS score 0-2;
  5. Have never received local or systemic anti-cancer treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
  6. Life expectancy of >3 months;
  7. Organ function levels must meet the following requirements:

(1)Bone marrow: White blood cell (WBC)≥4.0G/L;neutrophile granulocyte (NEU)≥1.5G/L;platelets (PLT)≥100G/L; hemoglobin (HGB)≥9g/L; (2)Liver and kidney: total bilirubin (TBIL), aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.0 × the upper limit of normal (ULN);creatinine≤1.5×ULN; 8.Patient must be willing and able to provide written informed consent.

Exclusion Criteria:

  1. The amount of metastatic focus >5;
  2. Patient can't tolerate chemotherapy or targeted therapy;
  3. Local or systemic anti-cancer treatment had been used for the primary foci and metastatic lymph nodes, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
  4. Previous or concurrent suffered from other malignancies;
  5. Concurrent with other serious disease that can not be controlled;
  6. Women who are breast-feeding or pregnant;
  7. Have an allergy to pemetrexed, cisplatin, taxanes, targeted medicine and contrast agent;
  8. Patients with poor obedience or researchers think that the patient may not be able to accomplish the whole trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119519


Contacts
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Contact: Xiaoxia Zhu, M.D. +862062787696 zhuxx01@126.com

Locations
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China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Xiaoxia Zhu, M.D.    +862062787696    zhuxx01@126.com   
Sponsors and Collaborators
Southern Medical University, China
Investigators
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Study Chair: Xiaoxia Zhu Nanfang Hospital of Southern Medical University
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Responsible Party: Xiaoxia Zhu, Professor, Southern Medical University, China
ClinicalTrials.gov Identifier: NCT03119519    
Other Study ID Numbers: LC2019ZD009
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaoxia Zhu, Southern Medical University, China:
NSCLC
Oligometastases
radiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms