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SIB Accelerated Hyperfractionated RT for High-Proliferation NSCLC

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, male or female;

Histologically or cytologically confirmed high-proliferation non-small cell lung cancer (NSCLC);

Assessed by a multidisciplinary team (MDT) and planned to receive thoracic radiotherapy (either curative or palliative), regardless of stage.

Disqualifiers

Small cell histology;

Severe cardiac disease (New York Heart Association [NYHA] functional class ≥ III, uncontrolled arrhythmia, or myocardial infarction within the past 6 months);

Pregnant or breastfeeding women, or patients of childbearing potential who are unwilling to use effective contraceptive measures;

Concurrent participation in other interventional clinical trials;

Trial design

Design model

Single group

Treatments tested in this trial

  • hyperfractionated radiotherapy

    Radiation

    simultaneous integrated boost accelerated hyperfractionated radiotherapy

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: hyperfractionated radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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

1

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.
2

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.
3

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, Zhejiang University, School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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