Oligo-metastatic Stage IV Non-small Cell Lung Cancer
Conditions
Keywords
intervention time, radiotherapy, oligometastatic, non-small cell lung cancer
Brief summary
This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.
Interventions
RADIATIONconcurrent 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.
DRUGDocetaxel
Docetaxel:60mg/m2 d1,Given IV
DRUGpemetrexed
pemetrexed: 500mg/m2 d1,Given IV
DRUGCisplatin
Cisplatin：25mg/m2 d1-3，Given IV
Sponsors
Mianyang Central Hospital
Cancer Hospital of Guizhou Province
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| short-term effects（The response rate，RR） | 3 months after the end of the treatment | Response Evaluation Criteria In Solid Tumors (RECIST) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS（progression-free survival） | up to 3 years | — |
| 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) |
| 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 |
Countries
China
Contacts
Primary ContactTAO LI, MD, PhD
Outcome results
None listed