Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"

Stage III Non-small Cell Lung Cancer Clinical Trial

Official title:

"Epidemiology, Approaches to the Diagnosis and Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05157503
• Other study ID #: 4
• Status: Recruiting
• Start date: January 10, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2021
• Source: Autonomous Non-Profit Organization National Society of Onco-Pulmonologists
• Contact: Konstantin Laktionov, Professor
• Phone: +7-903-170-97-95
• Email: lkoskos[@]mail.ru
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In connection with the transition to the 8th version of the classification of lung cancer according to the TNM system, there are currently no precise epidemiological data on stage III NSCLC, clinical characteristics of patients in this group, approaches to therapy and treatment results in the Russian Federation. The published statistics only provide information on the overall incidence of stage III lung, trachea and bronchial cancer, which is about 40%. This observational study will make it possible to characterize the Russian population of stage III non-small cell lung cancer patients, approaches to choosing a treatment option for stage III NSCLC and the outcomes of this treatment in real clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: March 31, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• stage III non-small cell lung cancer

Exclusion Criteria:

• the rest of the disease stage

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage III Non-small Cell Lung Cancer

Locations

Country	Name	City	State
Russian Federation	National Medical Research Center of Oncology. N. N. Blokhin	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Autonomous Non-Profit Organization National Society of Onco-Pulmonologists

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	-Evaluate the frequency of decision-making as a standard practice vs with an individual decision	Percentage of treatment options depending on: a. The nature of the progression; oligo progression; systemic progression; b. Prior treatment options v. after surgical treatment; d. Afte	10/01/2023
Primary	Examine clinical and morphological groups	gender ratio (husband, wife); smoking status (smoker, non-smoker, past smoker); proportional distribution: squamous cell, adenocarcinoma, dimorphic cancer, others); how many patients with mediastinal lymph node involvement: (N0, N1, N2, N3); detection frequency: PDL (PDL <1, PDL> 1, PDL <49, PDL> 50), EGFR (EGFR + (19.24 exon) EGFR-), (ALK +, ALK -), (ROS-1 +, ROS-1 -) Get information about regional algorithms; Variants of treatment tactics: Percentage: a. Surgery; v. Chemotherapy; -Diagnostic algorithm: a. Morphological verification frequency b. The frequency of confirmation of metastatic lesions within the thoracic lymph nodes c. F	10/01/2023
Secondary	Explore clinical approaches	Percentage of treatment options depending on: a. histological type; squamous; adenocarcinoma; dimorphic; 3 A st; 3B st	10/01/2023
Secondary	Diagnostic algorithm:	v. from a variant of molecular genetic disorders; PDL <1; PDL> 1; PDL <49; PDL> 50; EGFR +	10/01/2023
Secondary	Percentage of treatment options	from functional status; ECOG 1; only surgical treatment; surgical + drug treatment; surgical + drug treatment + radiation therapy; drug treatment; drug treatment + radiation therapy; radiation therapy; ECOG 2; only surgical treatment; surgical + drug treatment; surgical + drug treatment + radiation therapy; drug treatment; drug treatment + radiation therapy; radiation therapy; ECOG 3; only surgical treatment; surgical + drug treatment; surgical + drug treatment + radiation therapy; drug treatment; drug treatment + radiation therapy; radiation therapy	10/01/2023