Isotoxic hypofractionated chemoradiotherapy for non-small cell lung cancer

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

This study is testing a new way of giving radiation therapy to people with advanced non-small cell lung cancer who can't have the usual treatment, to see if it can work better and cause less harm to healthy tissue.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Second Hospital of Hebei Medical University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT03606239 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 unable to receive standard concurrent chemoradiation due to various health factors. The approach aims to personalize radiation doses based on individual patient characteristics, such as tumor size and location, rather than applying a uniform dose to all patients. By potentially shortening treatment time and improving local control rates, this method seeks to enhance the effectiveness of radiotherapy while minimizing damage to surrounding healthy tissues. The trial will include patients with specific eligibility criteria, focusing on those with advanced stages of NSCLC.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a diagnosis of non-small cell lung cancer at stage III who are not suitable for surgery or standard treatments.

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

Why it matters

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

How similar studies have performed: While the concept of isotoxic hypofractionated radiotherapy is innovative, similar approaches in personalized radiotherapy have shown promise in other studies.

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，≤ 75 years;
3. The expected survival period is ≥ 3 months;
4. Karnofsky performance status （KPS） score ≥ 60;
5. Normal blood account , liver and kidney function;
6. Forced expiratory volume in 1 second of 0.75 L or greater.

Exclusion Criteria:

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

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, hypofractionated radiotherapy, Non-Small-Cell Lung