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

NCT03119519 | Unknown Phase 2

• 1 other identifier: LC2019ZD009
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Non-small Cell Lung Cancer

Keywords

NSCLC; Oligometastases; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

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

  5 years

Secondary Outcomes (4)

• Local tumor control

  up to 5 years

• Oligometastatic foci control

  up to 5 years

• Thoracic Progression Free Survival

  up to 5 years

• Overall Survival

  up to 5 years

Study Arms (2)

Local Definitive Radiotherapy

EXPERIMENTAL

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.

Radiation: Local Definitive Radiotherapy; Drug: No Local Definitive Radiotherapy

No Local Definitive Radiotherapy

ACTIVE COMPARATOR

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

Drug: No Local Definitive Radiotherapy

Interventions

Local Definitive Radiotherapy RADIATION

three-dimensional conformal therapy or intensity modulated radiation therapy

Also known as: LDR

Local Definitive Radiotherapy

No Local Definitive Radiotherapy DRUG

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

Also known as: Non-LDR

Local Definitive Radiotherapy; No Local Definitive Radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaoxia Zhu

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Central Study Contacts

Xiaoxia Zhu, M.D.

CONTACT

+862062787696; zhuxx01@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: December 11, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)