Isotoxic hypofractionated radiotherapy for non-small cell lung cancer

A Phase II Open-Label Multi-center Trial of Isotoxic Hypofractionated Radiotherapy for NSCLC

This study is testing a new way of giving radiation therapy that tailors the dose for people with advanced non-small cell lung cancer who can't have chemotherapy, to see if it helps them feel better and have fewer side effects.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Second Hospital of Hebei Medical University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT03606291 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of isotoxic hypofractionated radiotherapy in patients with non-small cell lung cancer (NSCLC) who are not suitable for concurrent chemoradiation. The approach aims to personalize radiation doses based on individual patient factors, such as tumor size and location, rather than applying a uniform dose to all patients. By potentially reducing treatment time and minimizing damage to surrounding healthy tissues, this method seeks to improve local control rates and overall treatment outcomes for patients with advanced NSCLC.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of non-small cell lung cancer at stage III who are not candidates for surgery or standard treatments.

Not a fit: Patients with serious medical conditions requiring hospitalization or those with esophageal invasion may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer radiotherapy option for patients with non-small cell lung cancer.

How similar studies have performed: While the concept of isotoxic hypofractionation is innovative, similar approaches in personalized radiotherapy have shown promise in other studies, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Pathological or cytological diagnosis of non-small cell lung cancer patients, the clinical stage using the eighth edition of American Joint Committee on Cancer（AJCC）, including stage III without resectable or who when SBRT/SABR are not suitable;
2. Age ≥ 18 years;
3. The expected survival period is ≥ 3 months;
4. KPS score ≥ 60;
5. Normal blood count,liver and kidney function ≤ 2.5 times the upper limit of normal;

Exclusion Criteria:

1. Serious medical problems require hospitalization, included (but not limited to ): history of pulmonary fibrosis, previous myocardial infarction within 6 months, heart failure grade II and above, uncontrolled heart failure, uncontrolled COPD, uncontrolled diabetes Wait;
2. Esophageal invasion (cT4);
3. Others are not suitable for receiving radiotherapy.

Where this trial is running

Shijiazhuang, Hebei

• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (RECRUITING)

Study contacts

• Study coordinator: Xiao-Ying Xue, Professor

Conditions: Carcinoma, Non-Small-Cell Lung, isotoxic, hypofractionation, Non-Small-Cell Lung