SIB Accelerated Hyperfractionated RT for High-Proliferation NSCLC

Second Affiliated Hospital, Zhejiang University, School of Medicine15 enrolled

Overview

This is a prospective, single-arm, single-center phase I/II clinical trial evaluating the safety, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of simultaneous integrated boost accelerated hyperfractionated radiotherapy in patients with high-proliferation non-small cell lung cancer (NSCLC).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

hyperfractionated radiotherapyRADIATION

simultaneous integrated boost accelerated hyperfractionated radiotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years, male or female; 2. Histologically or cytologically confirmed high-proliferation non-small cell lung cancer (NSCLC); 3. Assessed by a multidisciplinary team (MDT) and planned to receive thoracic radiotherapy (either curative or palliative), regardless of stage. Exclusion Criteria: 1. Small cell histology; 2. Severe cardiac disease (New York Heart Association \[NYHA\] functional class ≥ III, uncontrolled arrhythmia, or myocardial infarction within the past 6 months); 3. Pregnant or breastfeeding women, or patients of childbearing potential who are unwilling to use effective contraceptive measures; 4. Concurrent participation in other interventional clinical trials; 5. Other conditions deemed by the investigator to make the patient unsuitable for enrollment (e.g., severe mental illness).

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Incidence of Acute Treatment-Related Toxicity

The incidence and severity of acute treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Time frame: From the start of radiotherapy through 90 days after completion of radiotherapy.

Incidence of Late Treatment-Related Toxicity

The incidence and severity of late treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Time frame: From more than 90 days after completion of radiotherapy through 2 years after completion of radiotherapy.

Secondary Outcomes

Objective Response Rate (ORR)

Objective response rate is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Time frame: Every 3 months after completion of radiotherapy, up to 2 years.

Progression-Free Survival (PFS)

Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first. Disease progression will be assessed according to RECIST version 1.1.

Time frame: From enrollment until documented disease progression or death from any cause, up to 2 years.

Overall Survival (OS)

Overall survival is defined as the time from enrollment to death from any cause.

Time frame: From enrollment until death from any cause, up to 2 years.

Central Contacts

Lu Wang

CONTACT

+86 057137826869 dluwang0727@163.com

Data from ClinicalTrials.gov

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