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

Overview

This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2020

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • short-term effects(The response rate,RR)
    • Time Frame: 3 months after the end of the treatment
    • Response Evaluation Criteria In Solid Tumors (RECIST)

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sichuan Cancer Hospital and Research Institute
  • Collaborator
    • Mianyang Central Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: LI TAO, Section Head – Sichuan Cancer Hospital and Research Institute
  • Overall Official(s)
    • JIAHUA LV, MD, Principal Investigator, Sichuan Cancer Hospital & Institute
    • XIAOHU WANG, MD, PhD, Principal Investigator, Gansu Cancer Hospital
    • XIAOBO DU, MD, PhD, Principal Investigator, Mianyang Central Hospital
    • BING LU, MD.PhD, Principal Investigator, Cancer Hospital of Guizhou Province
  • Overall Contact(s)
    • TAO LI, MD, PhD, 86-18908178818, litaoxmf@126.com

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