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

Primary Purpose

Non-small Cell Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

primary tumour radiotherapy

stereotactic body radiotherapy

maintenance radiotherapy

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell lung cancer, stereotactic body radiotherapy, CyberKnife, maintenance radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy

Arm Description

The patients, in whom disease stabilisation/partial regression will be achieved, will undergo primary tumour radiotherapy and stereotactic body radiotherapy, followed with maintenance radiotherapy.

Outcomes

Primary Outcome Measures

Acute and late toxicity

Acute and late toxicity of the combination therapy will be observed (according to Common Terminology for Clinical Adverse Event (CTCAE, version 5)

Progression-free survival

Progression-free survival will be observed

Secondary Outcome Measures

Overall survival

Overall survival will be observed

Share of nidi under local control

The share of nidi under local control will be observed (in per cent/total number of nidi)

Time to new nidus formation

The time to new nidus formation will be observed

Duration of maintenance chemotherapy

The duration of maintenance chemotherapy will be observed.

Full Information

NCT ID

NCT04758481

First Posted

February 4, 2021

Last Updated

December 6, 2022

Sponsor

University Hospital Ostrava

1. Study Identification

Unique Protocol Identification Number

NCT04758481

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 4, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer, stereotactic body radiotherapy, CyberKnife, maintenance radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

This is a non-randomised study with the primary intent to treat patients with NSCLC

Masking

None (Open Label)

Masking Description

The study is open label, no masking is being used.

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy

Arm Type

Experimental

Arm Description

The patients, in whom disease stabilisation/partial regression will be achieved, will undergo primary tumour radiotherapy and stereotactic body radiotherapy, followed with maintenance radiotherapy.

Intervention Type

Radiation

Intervention Name(s)

primary tumour radiotherapy

Intervention Description

The study subjects will undergo primary tumour radiotherapy.

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiotherapy

Intervention Description

The study subjects will undergo stereotactic body radiotherapy.

Intervention Type

Radiation

Intervention Name(s)

maintenance radiotherapy

Intervention Description

The study subjects will undergo maintenance radiotherapy.

Primary Outcome Measure Information:

Title

Acute and late toxicity

Description

Acute and late toxicity of the combination therapy will be observed (according to Common Terminology for Clinical Adverse Event (CTCAE, version 5)

Time Frame

every 3 months, throughout the study duration, up to 32 months in total

Title

Progression-free survival

Description

Progression-free survival will be observed

Time Frame

every 3 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival will be observed

Time Frame

every 3 months, throughout the study duration, up to 32 months in total

Title

Share of nidi under local control

Description

The share of nidi under local control will be observed (in per cent/total number of nidi)

Time Frame

every 3 months, throughout the study duration, up to 32 months in total

Title

Time to new nidus formation

Description

The time to new nidus formation will be observed

Time Frame

every 3 months, throughout the study duration, up to 32 months in total

Title

Duration of maintenance chemotherapy

Description

The duration of maintenance chemotherapy will be observed.

Time Frame

every 3 months, throughout the study duration, up to 32 months in total

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiří Hynčica

Phone

0042059737

Ext

2587

jiri.hyncica@fno.cz

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tereza Paračková, MD

Organizational Affiliation

University Hospital Ostrava

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ostrava

City

Ostrava

State/Province

Moravian-Silesian Region

ZIP/Postal Code

70852

Country

Czechia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiří Hynčica

Phone

0042059773

Ext

2587

jiri.hyncica@fno.cz

First Name & Middle Initial & Last Name & Degree

Tereza Paračková, MD

First Name & Middle Initial & Last Name & Degree

Pavel Dvořák, Ing.,Ph.D.

First Name & Middle Initial & Last Name & Degree

Lukáš Knybel, Ing.,Ph.D.

First Name & Middle Initial & Last Name & Degree

Kamila Resová, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

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

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