The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer（NSCLC）
NCT ID: NCT02076477
Last Updated: 2020-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
420 participants
INTERVENTIONAL
2014-01-31
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
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.
concurrent chemoradiotherapy
Radiation（image-guided radiotherapy）：（1）primary tumors≤3cm，Hypofractionated radiation therapy，accumulated dose BED ≥80Gy （central lung cancer），BED ≥100Gy（Peripheral lung cancer）.（2）primary tumors\>3cm，conventional fractionated radiotherapy，accumulated dose BED=60-66Gy/30-33f.（3） regional lymph node:conventional fractionated radiotherapy，accumulated dose BED=60-66Gy/30-33f.（4） Brain metastases： whole brain radiation therapy，36Gy/12f,Intracranial metastases，48Gy/12f.（5） bone metastasis：36 Gy/12f.
Docetaxel
Docetaxel:60mg/m2 d1,Given IV
pemetrexed
pemetrexed: 500mg/m2 d1,Given IV
Cisplatin
Cisplatin：25mg/m2 d1-3，Given IV
Arm B
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.
concurrent chemoradiotherapy
Radiation（image-guided radiotherapy）：（1）primary tumors≤3cm，Hypofractionated radiation therapy，accumulated dose BED ≥80Gy （central lung cancer），BED ≥100Gy（Peripheral lung cancer）.（2）primary tumors\>3cm，conventional fractionated radiotherapy，accumulated dose BED=60-66Gy/30-33f.（3） regional lymph node:conventional fractionated radiotherapy，accumulated dose BED=60-66Gy/30-33f.（4） Brain metastases： whole brain radiation therapy，36Gy/12f,Intracranial metastases，48Gy/12f.（5） bone metastasis：36 Gy/12f.
Docetaxel
Docetaxel:60mg/m2 d1,Given IV
pemetrexed
pemetrexed: 500mg/m2 d1,Given IV
Cisplatin
Cisplatin：25mg/m2 d1-3，Given IV
Interventions
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concurrent chemoradiotherapy
Radiation（image-guided radiotherapy）：（1）primary tumors≤3cm，Hypofractionated radiation therapy，accumulated dose BED ≥80Gy （central lung cancer），BED ≥100Gy（Peripheral lung cancer）.（2）primary tumors\>3cm，conventional fractionated radiotherapy，accumulated dose BED=60-66Gy/30-33f.（3） regional lymph node:conventional fractionated radiotherapy，accumulated dose BED=60-66Gy/30-33f.（4） Brain metastases： whole brain radiation therapy，36Gy/12f,Intracranial metastases，48Gy/12f.（5） bone metastasis：36 Gy/12f.
Docetaxel
Docetaxel:60mg/m2 d1,Given IV
pemetrexed
pemetrexed: 500mg/m2 d1,Given IV
Cisplatin
Cisplatin：25mg/m2 d1-3，Given IV
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Mianyang Central Hospital
OTHER
Cancer Hospital of Guizhou Province
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Responsible Party
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LI TAO
Section Head
Principal Investigators
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JIAHUA LV, MD
Role: PRINCIPAL_INVESTIGATOR
Sichuan Cancer Hospital and Research Institute
XIAOHU WANG, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gansu Cancer Hospital
XIAOBO DU, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mianyang Central Hospital
BING LU, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital of Guizhou Province
Locations
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Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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scch201402
Identifier Type: -
Identifier Source: org_study_id
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