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

NCT ID: NCT03119519

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-11
• Study Completion Date: 2021-09-30

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.

Conditions

Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Local Definitive Radiotherapy

Intervention Type: RADIATION

three-dimensional conformal therapy or intensity modulated radiation therapy

No Local Definitive Radiotherapy

Intervention Type: DRUG

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

No Local Definitive Radiotherapy

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

Group Type: ACTIVE_COMPARATOR

No Local Definitive Radiotherapy

Intervention Type: DRUG

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

Interventions

Local Definitive Radiotherapy

three-dimensional conformal therapy or intensity modulated radiation therapy

Intervention Type: RADIATION

No Local Definitive Radiotherapy

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

Intervention Type: DRUG

Other Intervention Names

LDR; Non-LDR

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Xiaoxia Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoxia Zhu

Role: STUDY_CHAIR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoxia Zhu, M.D.

Role: CONTACT

zhuxx01@126.com

+862062787696

Facility Contacts

Xiaoxia Zhu, M.D.

Role: primary

zhuxx01@126.com

+862062787696

Other Identifiers

LC2019ZD009

Identifier Type: -

Identifier Source: org_study_id