The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer（NSCLC）
Phase 3
- Conditions
- Oligo-metastatic Stage IV Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02076477
- Lead Sponsor
- Sichuan Cancer Hospital and Research Institute
- Brief Summary
This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 420
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.
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A concurrent chemoradiotherapy 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. Arm A Cisplatin 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. Arm B Cisplatin 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. Arm B concurrent chemoradiotherapy 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. Arm A Docetaxel 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. Arm A pemetrexed 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. Arm B Docetaxel 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. Arm B pemetrexed 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.
- Primary Outcome Measures
Name Time Method short-term effects（The response rate，RR） 3 months after the end of the treatment Response Evaluation Criteria In Solid Tumors (RECIST)
- Secondary Outcome Measures
Name Time Method PFS（progression-free survival） up to 3 years esophagitis and pneumonitis up to 3 years Grade 3-5 esophagitis and pneumonitis adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0
Other grade 3-5 adverse events up to 3 years Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0
Quality of life (QOL) up to 3 years Quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI) and lung cancer subscale (LCS)
Trial Locations
- Locations (1)
Sichuan Cancer Hospital & Institute
🇨🇳Chengdu, Sichuan, China