Clinical trial NCT03119519: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage IV Non-small Cell Lung Cancer
Keywords: NSCLC
Oligometastases
radiotherapy
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 cancer
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 5 years
Secondary outcomes:
measure: Local tumor control
timeFrame: up to 5 years
measure: Oligometastatic foci control
timeFrame: up to 5 years
measure: Thoracic Progression Free Survival
timeFrame: up to 5 years
measure: Overall Survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Xiaoxia Zhu
role: STUDY_CHAIR
References: