Consolidation Conventional Radiotherapy + Stereotactic Body Radiotherapy at 3 Months After First-line Chemotherapy in Stage IV Oligometastatic Non-small Cell Lung Cancer

December 6, 2022 updated by: University Hospital Ostrava

Consolidation Conventional Radiotherapy + Stereotactic Body Radiotherapy of All Body Locations With the Disease at 3 Months After First Line Chemotherapy in Stage IV Oligometastatic Non-small Cell Lung Cancer, Prior to Maintenance Therapy

Lung cancer is the main cause of death among cancer diseases, in the Czech Republic, as well as worldwide. Non-small cell lung cancer (NSCLC) is responsible for more than 80% of deaths among cancer patients. Bronchogenic carcinoma is the reason of death of almost 5.500 cases every year in the Czech Republic, the mortality/incidence ration varies around 85%. The main cause for these unfavorable findings is the late detection of the carcinoma in late stages only (III and IV), when a long-term control of the disease is exceptional. Chemotherapy is able to prolong the life of patients with NSCLC by less than one year on average, that is why new treatment approaches are being examined.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The basic treatment modality of lung cancer is radiotherapy, which has a proven therapeutic benefit in radical and palliative indications in up to 76% of all patients. Stereotactic robotic radiotherapy reaches maximum precision due to the precise definition of the target volume. In some localities, management with images has been solved using modern software instruments, which are able to visualize the tumor and monitor it during the whole course of respiratory cycle. This is directly associated with minimizing radiation of healthy tissues, especially the healthy lung parenchyma. In order to define predictive factors of survival of cancer patients, it is necessary to use molecular markers.

The aim of the study is to verify the feasibility of consolidation SBRT (Stereotactic Body RadioTherapy) - CyberKnife, with subsequent maintenance chemotherapy in patients with stage IV NSCLC, with max. 10 metastatic nidi. The main focus of the study will be on assessment of combination treatment toxicity.

The project is a phase I/II non-randomized clinical trial. Patients with stage IV NSCLC will be treated with 2-4 cycles of chemotherapy - platinum doublet (cisplatinum - cDDP/carboplatinum - CBDCA + Pemetrexed/navelibne - NVB). In cases when disease stabilization (SD)/partial resection (PR) will be achieved, based upon restaging examinations (CT), radiotherapy (RT) of the primary tumour will follow, with lymphadenopathy and SBRT of all metastatic nidi (max. 10 intra- or extracranial metastases). Standard fractionation schemes for RT and SBRT will be used (RT 40-50 Gy/16-20 fractions, SBRT 30 Gy/1 fractionation, 50-60 Gy/3-5 fractionations). At 3-6 weeks after the end of RT, maintenance treatment will be initiated in all patients treated with Peterexed. Regular restaging examinations are planned every 3 months.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Tereza Paračková, MD
        • Sub-Investigator:
          • Pavel Dvořák, Ing.,Ph.D.
        • Sub-Investigator:
          • Lukáš Knybel, Ing.,Ph.D.
        • Sub-Investigator:
          • Kamila Resová, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with previously untreated, non-resectable, stage IV NSCLC verified with histology or cytology (according to American Joint Committee on Cancer Version 8).
  • Patients must undergo 2-4 cycles of first-line chemotherapy, with the effect of disease stabilization or partial response.
  • Patients over 18 years of age.
  • Patients with measureable disease (on CT, PET/CT, MRI).
  • Patients with 3-10 extracranial/intracranial lesions confirmed on CT, PET/CT, MRI, max. 4 weeks prior to start of SBRT.
  • Max. 10 irradiated volumes (primary tumour + lymphadenopathy in one volume, if technically feasible).
  • Performance status (PS) 0-2 according to ECOG. Assessment of PS max. 7 days prior to start of treatment.
  • AST, ALT & ALP ≤ 2.5x norm. Total bilirubin must be within the normal range. 9. Normal function of bone marrow - Adiponectin ≥ 1.5, Haemoglobin ≥ 100, thrombo ≥ 100.
  • Serum creatinine ≤1.5x norm.
  • The entry laboratory tests must not be older than 14 days prior to start of treatment.
  • Negative pregnancy test and use of contraception in women of childbearing age.
  • Patients undergoing SBRT for pulmonary nidi must undergo entry spirometry with the value FEV1 (forced expiratory volume in 1 second) ≥ 1L.
  • Patients must sign informed consent.

Exclusion Criteria:

  • Patients with small-cell lung cancer or with mixed aetiology with SCLC.
  • Serious ongoing infections.
  • Patients with a history of haematopoiesis disorders.
  • Weight loss exceeding 10% within the last 3 months.
  • Patients with skin metastases of NSCLC.
  • Patients treated for other malignity within the last 5 years
  • Patients with more than 10 extracranial/intracranial metastases.
  • Malignant fluidothorax > 1 cm prior to start of treatment.
  • Patients treated with targeted treatment for EGFR mutation or EML-4-ALK translocation in the 1st-line (Erlotinib, Gefitinib, Afatinib, Crizotinib, …).
  • Patients treated with immunotherapy (anti-PD-1, anti-PD-L1 or anti-PD-L2, anti CTLA-4, …).
  • Participation in another clinical trial within the last month before the start of NSCLC treatment.
  • Inability to cooperate or comply with the study protocol.
  • Decision of the patient to discontinue participation in the study.
  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy
The patients, in whom disease stabilisation/partial regression will be achieved, will undergo primary tumour radiotherapy and stereotactic body radiotherapy, followed with maintenance radiotherapy.
Radiation: primary tumour radiotherapy
The study subjects will undergo primary tumour radiotherapy.
Radiation: stereotactic body radiotherapy
The study subjects will undergo stereotactic body radiotherapy.
Radiation: maintenance radiotherapy
The study subjects will undergo maintenance radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute and late toxicity
Time Frame: every 3 months, throughout the study duration, up to 32 months in total
Acute and late toxicity of the combination therapy will be observed (according to Common Terminology for Clinical Adverse Event (CTCAE, version 5)
every 3 months, throughout the study duration, up to 32 months in total
Progression-free survival
Time Frame: every 3 months
Progression-free survival will be observed
every 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: every 3 months, throughout the study duration, up to 32 months in total
Overall survival will be observed
every 3 months, throughout the study duration, up to 32 months in total
Share of nidi under local control
Time Frame: every 3 months, throughout the study duration, up to 32 months in total
The share of nidi under local control will be observed (in per cent/total number of nidi)
every 3 months, throughout the study duration, up to 32 months in total
Time to new nidus formation
Time Frame: every 3 months, throughout the study duration, up to 32 months in total
The time to new nidus formation will be observed
every 3 months, throughout the study duration, up to 32 months in total
Duration of maintenance chemotherapy
Time Frame: every 3 months, throughout the study duration, up to 32 months in total
The duration of maintenance chemotherapy will be observed.
every 3 months, throughout the study duration, up to 32 months in total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Tereza Paračková, MD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVO-FNOs/2020-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share the individual participant data with other researchers; the data may be provided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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