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The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer(NSCLC) (OITROLC)

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ClinicalTrials.gov Identifier: NCT02076477
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : March 17, 2020
Sponsor:
Collaborators:
Mianyang Central Hospital
Cancer Hospital of Guizhou Province
Information provided by (Responsible Party):
LI TAO, Sichuan Cancer Hospital and Research Institute

Tracking Information
First Submitted Date  ICMJE February 24, 2014
First Posted Date  ICMJE March 3, 2014
Last Update Posted Date March 17, 2020
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
short-term effects(The response rate,RR) [ Time Frame: 3 months after the end of the treatment ]
Response Evaluation Criteria In Solid Tumors (RECIST)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
  • PFS(progression-free survival) [ Time Frame: up to 3 years ]
  • Quality of life (QOL) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 3 years ]
    Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer(NSCLC)
Official Title  ICMJE The Prospective,Multicenter,Randomized Controlled Clinical Study of the Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer(NSCLC)
Brief Summary This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Oligo-metastatic Stage IV Non-small Cell Lung Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 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.

    Interventions:
    • Radiation: concurrent chemoradiotherapy
    • Drug: Docetaxel
    • Drug: pemetrexed
    • Drug: Cisplatin
  • Active Comparator: 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.

    Interventions:
    • Radiation: concurrent chemoradiotherapy
    • Drug: Docetaxel
    • Drug: pemetrexed
    • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2014)
420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: TAO LI, MD, PhD 86-18908178818 litaoxmf@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02076477
Other Study ID Numbers  ICMJE scch201402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LI TAO, Sichuan Cancer Hospital and Research Institute
Study Sponsor  ICMJE Sichuan Cancer Hospital and Research Institute
Collaborators  ICMJE
  • Mianyang Central Hospital
  • Cancer Hospital of Guizhou Province
Investigators  ICMJE
Principal Investigator: JIAHUA LV, MD Sichuan Cancer Hospital & Institute
Principal Investigator: XIAOHU WANG, MD, PhD Gansu Cancer Hospital
Principal Investigator: XIAOBO DU, MD, PhD Mianyang Central Hospital
Principal Investigator: BING LU, MD.PhD Cancer Hospital of Guizhou Province
PRS Account Sichuan Cancer Hospital and Research Institute
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP