Clinical trial · Interventional
SIB Accelerated Hyperfractionated RT for High-Proliferation NSCLC
A Single-arm Phase I/II Clinical Study of Simultaneous Integrated Boost Accelerated Hyperfractionated Radiotherapy for High-proliferation Non-small Cell Lung Cancer
NCT07823855CI-TRIAL-00126354HP-SIB-AHFRTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperfractionated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- hyperfractionated radiotherapy
- description
- simultaneous integrated boost accelerated hyperfractionated radiotherapy
- interventionNames
- Radiation: hyperfractionated radiotherapy
Primary outcomes (2)
- measure
- Incidence of Acute Treatment-Related Toxicity
- timeFrame
- From the start of radiotherapy through 90 days after completion of radiotherapy.
- description
- 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.
- measure
- Incidence of Late Treatment-Related Toxicity
- timeFrame
- From more than 90 days after completion of radiotherapy through 2 years after completion of radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.