SBRT/RT in Oligometastatic Stage IV NSCLC

NCT05647590 | Unknown

• 1 other identifier: FNO-ONK-RT+SBRT/CHT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 10 metastatic sites will improve progression-free survival (PFS) with acceptable toxicity compared to maintenance chemotherapy alone.

Conditions

Non Small Cell Lung Cancer

Keywords

non small cell lung cancer; radiotherapy; stereotactic robotic radiotherapy; chemotherapy; CyberKnife; acceptable toxicity

Outcome Measures

Primary Outcomes (2)

• Grade of Toxicity

  Grade of toxicity of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4

  up to 12 months

• Progression-Free Survival

  Progression-free survival (PFS) will be observed (in months)

  up to 12 months

Secondary Outcomes (4)

• Overall Survival

  up to 12 months

• Time to new lesion

  up to 12 months)

• Duration of maintenance chemotherapy

  up to 12 months

• Restriction volume of pulmonary capacity

  up to 12 months

Study Arms (1)

NSCLC patients

EXPERIMENTAL

Patients with non-small cell lung cancer (NSCLC) will be enrolled in the study.

Procedure: Chemotherapy; Procedure: Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT); Procedure: Maintenance chemotherapy

Interventions

Chemotherapy PROCEDURE

3 months of platinum doublet chemotherapy (cDDP / CBDCA + Pemetrexed, NVB)

NSCLC patients

Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT) PROCEDURE

* RT to primary tumor + SBRT to all oligometa (max. 10 intra / extracranial lesions, intracranial SD / PR) * SBRT V \< 100 ml, if technically possible fractionation RT (40 - 50 Gy / 16 - 20 fractions), SBRT (30 Gy / 1 fraction, 50 - 60 Gy / 3 - 5 fractions) 3 - 6 weeks … maintenance

NSCLC patients

Maintenance chemotherapy PROCEDURE

Maintenance chemotherapy will follow 3-6 weeks after RT.

NSCLC patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have biopsy-proven metastatic NSCLC (Stage IV).
• Patients must have received three months of first-line chemotherapy and achieved stable disease or partial response.
• Age ≥ 18 years
• Patients must have measurable disease at baseline.
• Patients can have up to 10 discrete active extracranial/intracranial lesions identified by PET/CT or MRI scan within 8 weeks prior to the initiation of SBRT.
• Patients must have a Karnofsky Performance Scale (KPS) \>60
• AST, ALT \& Alkaline phosphates must be ≤ 2.5x the upper limit of normal. Total bilirubin must be within the limit of normal.
• Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
• Patients should have adequate renal function (serum creatinine ≤1.5 times the upper limit of normal (ULN).
• Females of childbearing potential should have a negative pregnancy test.
• Patients who would be receiving SBRT for lung tumors must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
• Patients must provide verbal and written informed consent to participate in the study

You may not qualify if:

• Patients receiving first-line erlotinib, gefitinib, or crizotinib for EGFR mutant-positive or EML4-ALK-positive NSCLC will be excluded.
• Patients who previously received radiotherapy at the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy
• Patients with serious, uncontrolled, concurrent infection(s)
• Significant weight loss (\>10%) in the prior 3 months
• Patients with cutaneous metastasis of NSCLC
• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers
• Patients with more than 10 discrete extra/intracranial lesions
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment
• Unwillingness to participate or inability to comply with the protocol for the duration of the study
• Patients who are pregnant; patients with reproductive capability will need to use adequate contraception during the time of participation in the study

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy; Radiotherapy; Maintenance Chemotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Tereza Paračková, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: October 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)