The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer(NSCLC) (OITROLC)
Oligo-metastatic Stage IV Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Oligo-metastatic Stage IV Non-small Cell Lung Cancer focused on measuring intervention time, radiotherapy, oligometastatic, non-small cell lung cancer
Eligibility Criteria
Inclusion Criteria:
- 18 to 75 years old , male or female
- Pathologically or cytologically proven oligometastatic stage IV NSCLC non-small cell lung cancer(NSCLC)
- Primary tumors can be measured
- Distant organ metastases number ≤ 5
- Karnofsky score >70,Zubrod performance status 0-1
- Estimated life expectancy of at least 12 weeks
- reproductive age women should ensure that before entering the study period contraception
- Hemoglobin≥10.0g/dL,WBC≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Patients have good compliance to treatment and follow-up of acceptance.
Exclusion Criteria:
- Allergic to pemetrexed, cisplatin, docetaxel and contrast medium
- Distant metastases organs > 5
- The primary tumor or lymph node already received surgical treatment (except for biopsy)
- Patient who received radiotherapy for primary tumor or lymph node
- Patient who received the the epidermal growth factor targeted therapy
- Patient who received chemotherapy or immunotherapy
- Patient who suffered from other malignant tumor
- Patient who have taken other drug test within 1 month
- Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period
- Subject with a severe allergic history or idiosyncratic
- Subject with severe pulmonary and cardiopathic disease history
- Refuse or incapable to sign the informed consent form of participating this trial
- Drug abuse or alcohol addicted
- Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct
Sites / Locations
- Sichuan Cancer Hospital & InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A
Arm B
Patients receive concurrent chemoradiotherapy at first。Patients also receive chemotherapy every 3-4 weeks for two cycles after concurrent chemoradiotherapy. chemotherapy:(1) squamous cell carcinoma:Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.(2)non squamous cell carcinoma: pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
Patients receive neoadjuvant chemotherapy every 3-4 weeks for two cycles at first.Patients then receive concurrent chemoradiotherapy after neoadjuvant chemotherapy. chemotherapy:(1) squamous cell carcinoma:Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.(2)non squamous cell carcinoma: pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.