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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer :A Multicenter,Randomized,Controlled,Phase 2 Study.

Conditions
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Stage IV Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Local Definitive Radiotherapy
* Drug: No Local Definitive Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 to 70 years old; Histologically or cytologically confirmed non-small cell lung cancer; Stage IV patients with measurable primary tumor and distant metastases number ≤5； PS score 0-2； Have never received local or systemic anti-cancer treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy; Life expectancy of >3 months; 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: The amount of metastatic focus >5; Patient can't tolerate chemotherapy or targeted therapy; 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; Previous or concurrent suffered from other malignancies; Concurrent with other serious disease that can not be controlled; Women who are breast-feeding or pregnant; Have an allergy to pemetrexed, cisplatin, taxanes, targeted medicine and contrast agent; Patients with poor obedience or researchers think that the patient may not be able to accomplish the whole trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local Definitive Radiotherapy<br>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<br>* three-dimensional conformal therapy or intensity modulated radiation therapy<br>* Other names: LDR;Drug: No Local Definitive Radiotherapy<br>* Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.<br>* Other names: Non-LDR;|
| Active Comparator: No Local Definitive Radiotherapy<br>Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test. | Drug: No Local Definitive Radiotherapy<br>* Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.<br>* Other names: Non-LDR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | Refers to the time from randomization to disease progression or death. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor control | From time of randomization to time of progression or death（according to RECIST v1.1 [） | up to 5 years | 
| Oligometastatic foci control | From time of first chemotherapy or targeted therapy to time of progression or death（according to RECIST v1.1） | up to 5 years | 
| Thoracic Progression Free Survival | From time of first chemotherapy or targeted therapy to time of progression or death | up to 5 years | 
| Overall Survival | From time of first chemotherapy or targeted therapy to date of death | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Oligometastases, radiotherapy