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

Phase 2UnknownNCT03119519

Southern Medical University, China148 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Stage IV Non-small Cell Lung Cancer

Interventions

Local Definitive RadiotherapyRADIATION

three-dimensional conformal therapy or intensity modulated radiation therapy

No Local Definitive RadiotherapyDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Progression-free Survival (PFS)

Refers to the time from randomization to disease progression or death.

Time frame: 5 years

Secondary Outcomes

Local tumor control

From time of randomization to time of progression or death（according to RECIST v1.1 \[）

Time frame: 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）

Time frame: up to 5 years

Thoracic Progression Free Survival

From time of first chemotherapy or targeted therapy to time of progression or death

Time frame: up to 5 years

Overall Survival

From time of first chemotherapy or targeted therapy to date of death

Time frame: up to 5 years

Central Contacts

Xiaoxia Zhu, M.D.

CONTACT

+862062787696 zhuxx01@126.com

Data from ClinicalTrials.gov

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