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

NCT04758481 | Unknown

• 1 other identifier: RVO-FNOs/2020-22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

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

• Progression-free survival

  Progression-free survival will be observed

  every 3 months

Secondary Outcomes (4)

• Overall survival

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

• Share of nidi under local control

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

• Time to new nidus formation

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

• Duration of maintenance chemotherapy

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

Study Arms (1)

Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy

EXPERIMENTAL

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; Radiation: stereotactic body radiotherapy; Radiation: maintenance radiotherapy

Interventions

primary tumour radiotherapy RADIATION

The study subjects will undergo primary tumour radiotherapy.

Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy

stereotactic body radiotherapy RADIATION

The study subjects will undergo stereotactic body radiotherapy.

Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy

maintenance radiotherapy RADIATION

The study subjects will undergo maintenance radiotherapy.

Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (10)

• Siva S, MacManus M, Ball D. Stereotactic radiotherapy for pulmonary oligometastases: a systematic review. J Thorac Oncol. 2010 Jul;5(7):1091-9. doi: 10.1097/JTO.0b013e3181de7143.

  PMID: 20479693 BACKGROUND

• Onishi H, Shirato H, Nagata Y, Hiraoka M, Fujino M, Gomi K, Karasawa K, Hayakawa K, Niibe Y, Takai Y, Kimura T, Takeda A, Ouchi A, Hareyama M, Kokubo M, Kozuka T, Arimoto T, Hara R, Itami J, Araki T. Stereotactic body radiotherapy (SBRT) for operable stage I non-small-cell lung cancer: can SBRT be comparable to surgery? Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1352-8. doi: 10.1016/j.ijrobp.2009.07.1751. Epub 2010 Jul 16.

  PMID: 20638194 BACKGROUND

• Takeda A, Kunieda E, Ohashi T, Aoki Y, Koike N, Takeda T. Stereotactic body radiotherapy (SBRT) for oligometastatic lung tumors from colorectal cancer and other primary cancers in comparison with primary lung cancer. Radiother Oncol. 2011 Nov;101(2):255-9. doi: 10.1016/j.radonc.2011.05.033.

  PMID: 21641064 BACKGROUND

• Collen C, Christian N, Schallier D, Meysman M, Duchateau M, Storme G, De Ridder M. Phase II study of stereotactic body radiotherapy to primary tumor and metastatic locations in oligometastatic nonsmall-cell lung cancer patients. Ann Oncol. 2014 Oct;25(10):1954-1959. doi: 10.1093/annonc/mdu370. Epub 2014 Aug 11.

  PMID: 25114022 BACKGROUND

• Norihisa Y, Nagata Y, Takayama K, Matsuo Y, Sakamoto T, Sakamoto M, Mizowaki T, Yano S, Hiraoka M. Stereotactic body radiotherapy for oligometastatic lung tumors. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):398-403. doi: 10.1016/j.ijrobp.2008.01.002. Epub 2008 Apr 18.

  PMID: 18374506 BACKGROUND

• Guerrero E, Ahmed M. The role of stereotactic ablative radiotherapy (SBRT) in the management of oligometastatic non small cell lung cancer. Lung Cancer. 2016 Feb;92:22-8. doi: 10.1016/j.lungcan.2015.11.015. Epub 2015 Dec 2.

  PMID: 26775592 BACKGROUND

• Oh D, Ahn YC, Seo JM, Shin EH, Park HC, Lim DH, Pyo H. Potentially curative stereotactic body radiation therapy (SBRT) for single or oligometastasis to the lung. Acta Oncol. 2012 May;51(5):596-602. doi: 10.3109/0284186X.2012.681698. Epub 2012 May 1.

  PMID: 22548366 BACKGROUND

• Singh D, Chen Y, Hare MZ, Usuki KY, Zhang H, Lundquist T, Joyce N, Schell MC, Milano MT. Local control rates with five-fraction stereotactic body radiotherapy for oligometastatic cancer to the lung. J Thorac Dis. 2014 Apr;6(4):369-74. doi: 10.3978/j.issn.2072-1439.2013.12.03.

  PMID: 24688781 BACKGROUND

• Lussier YA, Xing HR, Salama JK, Khodarev NN, Huang Y, Zhang Q, Khan SA, Yang X, Hasselle MD, Darga TE, Malik R, Fan H, Perakis S, Filippo M, Corbin K, Lee Y, Posner MC, Chmura SJ, Hellman S, Weichselbaum RR. MicroRNA expression characterizes oligometastasis(es). PLoS One. 2011;6(12):e28650. doi: 10.1371/journal.pone.0028650. Epub 2011 Dec 13.

  PMID: 22174856 BACKGROUND

• Wong AC, Watson SP, Pitroda SP, Son CH, Das LC, Stack ME, Uppal A, Oshima G, Khodarev NN, Salama JK, Weichselbaum RR, Chmura SJ. Clinical and molecular markers of long-term survival after oligometastasis-directed stereotactic body radiotherapy (SBRT). Cancer. 2016 Jul 15;122(14):2242-50. doi: 10.1002/cncr.30058. Epub 2016 May 20.

  PMID: 27206146 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

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)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

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
• Masking Details: The study is open label, no masking is being used.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 17, 2021
• Study Start: May 4, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)