Oligo-metastatic Stage IV Non-small Cell Lung Cancer Clinical Trial
— OITROLCOfficial 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）
This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.
| Status | Recruiting |
| Enrollment | 420 |
| Est. completion date | October 2020 |
| Est. primary completion date | October 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Sichuan Cancer Hospital & Institute | Chengdu | Sichuan |
| Lead Sponsor | Collaborator |
|---|---|
| Sichuan Cancer Hospital and Research Institute | Cancer Hospital of Guizhou Province, Mianyang Central Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | short-term effects(The response rate,RR) | Response Evaluation Criteria In Solid Tumors (RECIST) | 3 months after the end of the treatment | |
| Secondary | PFS(progression-free survival) | up to 3 years | ||
| Secondary | Quality of life (QOL) | Quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI) and lung cancer subscale (LCS) | up to 3 years | |
| Secondary | esophagitis and pneumonitis | Grade 3-5 esophagitis and pneumonitis adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 | up to 3 years | |
| Secondary | Other grade 3-5 adverse events | Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0 | up to 3 years |