Trial | NCT02076477  Report issue

Title

The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer（NSCLC）
The Prospective,Multicenter,Randomized Controlled Clinical Study of the Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer（NSCLC）

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    420
This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.
Study Started
Jan 31
2014
Primary Completion
Oct 31
2020
Anticipated
Study Completion
Oct 31
2020
Anticipated
Last Update
Mar 17
2020

Radiation 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.

Drug Docetaxel

Docetaxel:60mg/m2 d1,Given IV

Drug pemetrexed

pemetrexed: 500mg/m2 d1,Given IV

Drug Cisplatin

Cisplatin：25mg/m2 d1-3，Given IV

Arm A Experimental

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 Active Comparator

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.

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
No Results Posted