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

• ClinicalTrials.gov Identifier: NCT03119519
• Recruitment Status: Recruiting
• First Posted: April 18, 2017
• Last Update Posted: March 18, 2020
• Sponsor: Southern Medical University, China
• Information provided by (Responsible Party): Xiaoxia Zhu, Southern Medical University, China

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stage IV Non-small Cell Lung Cancer	Radiation: Local Definitive Radiotherapy; Drug: No Local Definitive Radiotherapy	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 148 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer :A Multicenter,Randomized,Controlled,Phase 2 Study.
• Actual Study Start Date: December 11, 2017
• Estimated Primary Completion Date: September 2020
• Estimated Study Completion Date: September 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Radiation: Local Definitive Radiotherapy; three-dimensional conformal therapy or intensity modulated radiation therapy; Other Name: LDR; Drug: No Local Definitive Radiotherapy; Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.; Other Name: Non-LDR
Active Comparator: No Local Definitive Radiotherapy; Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.	Drug: No Local Definitive Radiotherapy; Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.; Other Name: Non-LDR

Outcome Measures

Primary Outcome Measures :

1. Progression-free Survival (PFS) [ Time Frame: 5 years ]
   Refers to the time from randomization to disease progression or death.

Secondary Outcome Measures :

1. Local tumor control [ Time Frame: up to 5 years ]
   From time of randomization to time of progression or death（according to RECIST v1.1 [）
2. Oligometastatic foci control [ Time Frame: up to 5 years ]
   From time of first chemotherapy or targeted therapy to time of progression or death（according to RECIST v1.1）
3. Thoracic Progression Free Survival [ Time Frame: up to 5 years ]
   From time of first chemotherapy or targeted therapy to time of progression or death
4. Overall Survival [ Time Frame: up to 5 years ]
   From time of first chemotherapy or targeted therapy to date of death

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Xiaoxia Zhu, M.D.; +862062787696; zhuxx01@126.com

Locations

China, Guangdong

Nanfang Hospital, Southern Medical University; Recruiting

Guangzhou, Guangdong, China, 510515

Contact: Xiaoxia Zhu, M.D. +862062787696 zhuxx01@126.com

Sponsors and Collaborators

Southern Medical University, China

Investigators

• Study Chair: Xiaoxia Zhu; Nanfang Hospital of Southern Medical University

More Information

• Responsible Party: Xiaoxia Zhu, Professor, Southern Medical University, China
• ClinicalTrials.gov Identifier: NCT03119519
• Other Study ID Numbers: LC2019ZD009
• First Posted: April 18, 2017
• Last Update Posted: March 18, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaoxia Zhu, Southern Medical University, China:

NSCLC; Oligometastases; radiotherapy

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms