Clinical trial NCT02076477: The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer（NSCLC）
Official title: The Prospective,Multicenter,Randomized Controlled Clinical Study of the Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer（NSCLC）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Oligo-metastatic Stage IV Non-small Cell Lung Cancer
Keywords: intervention time
radiotherapy
oligometastatic
non-small cell lung cancer
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Mianyang Central Hospital
name: Cancer Hospital of Guizhou Province
First posted: 2014-03-03
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv 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

Primary outcomes:
measure: short-term effects（The response rate，RR）
timeFrame: 3 months after the end of the treatment
Secondary outcomes:
measure: PFS（progression-free survival）
timeFrame: up to 3 years
measure: Quality of life (QOL)
timeFrame: up to 3 years
measure: esophagitis and pneumonitis
timeFrame: up to 3 years
measure: Other grade 3-5 adverse events
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital & Institute
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: JIAHUA LV, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gansu Cancer Hospital
name: XIAOHU WANG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mianyang Central Hospital
name: XIAOBO DU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Hospital of Guizhou Province
name: BING LU, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: