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

Stage IV Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03119519
• Other study ID #: LC2019ZD009
• Status: Recruiting
• Phase: Phase 2
• Start date: December 11, 2017
• Est. completion date: September 2021

Study information

• Verified date: March 2020
• Source: Southern Medical University, China
• Contact: Xiaoxia Zhu, M.D.
• Phone: +862062787696
• Email: zhuxx01[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage IV Non-small Cell Lung Cancer

Intervention

Radiation:
• Local Definitive Radiotherapy
three-dimensional conformal therapy or intensity modulated radiation therapy

Drug:
• No Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	Refers to the time from randomization to disease progression or death.	5 years
Secondary	Local tumor control	From time of randomization to time of progression or death(according to RECIST v1.1 [)	up to 5 years
Secondary	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
Secondary	Thoracic Progression Free Survival	From time of first chemotherapy or targeted therapy to time of progression or death	up to 5 years
Secondary	Overall Survival	From time of first chemotherapy or targeted therapy to date of death	up to 5 years