Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer.

Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer :A Multicenter,Randomized,Controlled,Phase 2 Study.

Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in this subset of patients.

Study Overview

• Status: Unknown
• Conditions: Stage IV Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: Local Definitive Radiotherapy; Drug: No Local Definitive Radiotherapy

Detailed Description

For NSCLC patients with synchronous oligometastases, first line chemotherapy or targeted therapy concurrent with non-salvage radiotherapy on metastatic or primary thoracic tumor contributed a longer progression-free survival than chemotherapy or targeted therapy alone.

• Study Type: Interventional
• Enrollment (Anticipated): 148
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Xiaoxia Zhu, M.D.; Phone Number: +862062787696; Email: zhuxx01@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female aged 18 to 70 years old;
2. Histologically or cytologically confirmed non-small cell lung cancer;
3. Stage IV patients with measurable primary tumor and distant metastases number ≤5；
4. PS score 0-2；
5. Have never received local or systemic anti-cancer treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
6. Life expectancy of >3 months;
7. Organ function levels must meet the following requirements:

(1)Bone marrow: White blood cell (WBC)≥4.0G/L；neutrophile granulocyte (NEU)≥1.5G/L；platelets (PLT)≥100G/L; hemoglobin (HGB)≥9g/L； (2)Liver and kidney: total bilirubin (TBIL), aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.0 × the upper limit of normal (ULN)；creatinine≤1.5×ULN; 8.Patient must be willing and able to provide written informed consent.

Exclusion Criteria:

1. The amount of metastatic focus >5;
2. Patient can't tolerate chemotherapy or targeted therapy;
3. Local or systemic anti-cancer treatment had been used for the primary foci and metastatic lymph nodes, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
4. Previous or concurrent suffered from other malignancies;
5. Concurrent with other serious disease that can not be controlled;
6. Women who are breast-feeding or pregnant;
7. Have an allergy to pemetrexed, cisplatin, taxanes, targeted medicine and contrast agent;
8. Patients with poor obedience or researchers think that the patient may not be able to accomplish the whole trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Local Definitive Radiotherapy; Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) followed by 3D-CRT (three-dimensional conformal radiotherapy) or IMRT (intensity modulated radiotherapy) to primary thoracic foci or remediable oligometastatic focus.	Radiation: Local Definitive Radiotherapy; three-dimensional conformal therapy or intensity modulated radiation therapy; Other Names: LDR; Drug: No Local Definitive Radiotherapy; Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.; Other Names: Non-LDR
Active Comparator: No Local Definitive Radiotherapy; Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.	Drug: No Local Definitive Radiotherapy; Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.; Other Names: Non-LDR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Refers to the time from randomization to disease progression or death.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tumor control	From time of randomization to time of progression or death（according to RECIST v1.1 [）	up to 5 years
Oligometastatic foci control	From time of first chemotherapy or targeted therapy to time of progression or death（according to RECIST v1.1）	up to 5 years
Thoracic Progression Free Survival	From time of first chemotherapy or targeted therapy to time of progression or death	up to 5 years
Overall Survival	From time of first chemotherapy or targeted therapy to date of death	up to 5 years

Collaborators and Investigators

• Sponsor: Southern Medical University, China
• Investigators: Study Chair: Xiaoxia Zhu, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: NSCLC; radiotherapy; Oligometastases
• 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
• Other Study ID Numbers: LC2019ZD009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No