Stage IV Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, Oligometastases, radiotherapy
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.
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.
Interventions
RADIATIONLocal Definitive Radiotherapy
three-dimensional conformal therapy or intensity modulated radiation therapy
DRUGNo Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
Sponsors
Southern Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | 5 years | Refers to the time from randomization to disease progression or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local tumor control | up to 5 years | From time of randomization to time of progression or death（according to RECIST v1.1 \[） |
| Oligometastatic foci control | up to 5 years | From time of first chemotherapy or targeted therapy to time of progression or death（according to RECIST v1.1） |
| Thoracic Progression Free Survival | up to 5 years | From time of first chemotherapy or targeted therapy to time of progression or death |
| Overall Survival | up to 5 years | From time of first chemotherapy or targeted therapy to date of death |
Countries
China
Contacts
Primary ContactXiaoxia Zhu, M.D.
Outcome results
None listed