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

Sponsor

Southern Medical University, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT03119519

Collaborator

(none)

148

Enrollment

Location

Arms

44.7

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stage IV Non-small Cell Lung Cancer	Radiation: Local Definitive Radiotherapy Drug: No Local Definitive Radiotherapy	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized phase II trial of first line chemotherapy or targeted therapy plus local definitive radiotherapy or not for patients with synchronous oligometastatic non-small cell lung cancerA randomized phase II trial of first line chemotherapy or targeted therapy plus local definitive radiotherapy or not for patients with synchronous oligometastatic non-small cell lung cancer

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 11, 2017

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Progression-free Survival (PFS) [5 years]
Refers to the time from randomization to disease progression or death.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

The amount of metastatic focus >5;
Patient can't tolerate chemotherapy or targeted therapy;
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;
Previous or concurrent suffered from other malignancies;
Concurrent with other serious disease that can not be controlled;
Women who are breast-feeding or pregnant;
Have an allergy to pemetrexed, cisplatin, taxanes, targeted medicine and contrast agent;
Patients with poor obedience or researchers think that the patient may not be able to accomplish the whole trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

Southern Medical University, China

Investigators

Study Chair: Xiaoxia Zhu, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaoxia Zhu, Professor, Southern Medical University, China

ClinicalTrials.gov Identifier:

NCT03119519

Other Study ID Numbers:

LC2019ZD009

First Posted:

Apr 18, 2017

Last Update Posted:

Mar 18, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xiaoxia Zhu, Professor, Southern Medical University, China

NSCLC

Oligometastases

radiotherapy

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Mar 18, 2020