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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

Study Description
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Brief Summary:
This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.

Condition or disease Intervention/treatment Phase
Oligo-metastatic Stage IV Non-small Cell Lung Cancer Radiation: concurrent chemoradiotherapy Drug: Docetaxel Drug: pemetrexed Drug: Cisplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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）
Study Start Date : January 2014
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.

 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
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.

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. PFS（progression-free survival） [ Time Frame: up to 3 years ]
  2. 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)

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076477


Contacts
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Contact: TAO LI, MD, PhD 86-18908178818 litaoxmf@126.com

Locations
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China, Sichuan
Sichuan Cancer Hospital & Institute Recruiting
Chengdu, Sichuan, China, 610041
Contact: TAO LI, MD, PhD    86-18908178818    litaoxmf@163.com   
Principal Investigator: TAO LI, MD, PhD         
Sub-Investigator: XIAOHU WANG, MD, PhD         
Sub-Investigator: XIAOBO DU, MD, PhD         
Sub-Investigator: BING LU, MD, PhD         
Sponsors and Collaborators
Sichuan Cancer Hospital and Research Institute
Mianyang Central Hospital
Cancer Hospital of Guizhou Province
Investigators
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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
More Information
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Responsible Party: LI TAO, Section Head, Sichuan Cancer Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02076477    
Other Study ID Numbers: scch201402
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Keywords provided by LI TAO, Sichuan Cancer Hospital and Research Institute:
intervention time
radiotherapy
oligometastatic
non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
 Docetaxel
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors