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

Primary Purpose

Stage IV Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Local Definitive Radiotherapy
No Local Definitive Radiotherapy
Sponsored by
Southern Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Non-small Cell Lung Cancer focused on measuring NSCLC, Oligometastases, radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Local Definitive Radiotherapy

No Local Definitive Radiotherapy

Arm Description

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.

Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2017
Last Updated
March 16, 2020
Sponsor
Southern Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT03119519
Brief Title
Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer.
Official Title
Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer :A Multicenter,Randomized,Controlled,Phase 2 Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Non-small Cell Lung Cancer
Keywords
NSCLC, Oligometastases, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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 cancer
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local Definitive Radiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
No Local Definitive Radiotherapy
Arm Type
Active Comparator
Arm Description
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
Intervention Type
Radiation
Intervention Name(s)
Local Definitive Radiotherapy
Other Intervention Name(s)
LDR
Intervention Description
three-dimensional conformal therapy or intensity modulated radiation therapy
Intervention Type
Drug
Intervention Name(s)
No Local Definitive Radiotherapy
Other Intervention Name(s)
Non-LDR
Intervention Description
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
Refers to the time from randomization to disease progression or death.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Local tumor control
Description
From time of randomization to time of progression or death（according to RECIST v1.1 [）
Time Frame
up to 5 years
Title
Oligometastatic foci control
Description
From time of first chemotherapy or targeted therapy to time of progression or death（according to RECIST v1.1）
Time Frame
up to 5 years
Title
Thoracic Progression Free Survival
Description
From time of first chemotherapy or targeted therapy to time of progression or death
Time Frame
up to 5 years
Title
Overall Survival
Description
From time of first chemotherapy or targeted therapy to date of death
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoxia Zhu, M.D.
Phone
+862062787696
Email
zhuxx01@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoxia Zhu
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxia Zhu, M.D.
Phone
+862062787696
Email
zhuxx01@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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