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

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.

Study Overview

• Status: Unknown
• Conditions: Oligo-metastatic Stage IV Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: concurrent chemoradiotherapy; Drug: Docetaxel; Drug: pemetrexed; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 420
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: TAO LI, MD, PhD; Phone Number: 86-18908178818; Email: litaoxmf@126.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer Hospital & Institute
      • Sub-Investigator: XIAOHU WANG, MD, PhD
      • Sub-Investigator: XIAOBO DU, MD, PhD
      • Sub-Investigator: BING LU, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS（progression-free survival）		up to 3 years
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
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
Other grade 3-5 adverse events	Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0	up to 3 years

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute
• Collaborators: Mianyang Central Hospital; Cancer Hospital of Guizhou Province
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (ESTIMATE): March 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; radiotherapy; oligometastatic; intervention time
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Folic Acid Antagonists; Docetaxel; Cisplatin; Pemetrexed
• Other Study ID Numbers: scch201402