A Phase II Study of Accelerated Hypofractionated Three-dimensional Conformal Radiation Therapy Concurrent With Chemotherapy in Unresectable Stage III Non-small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Primary Endpoint
- Number of Participants with Severe and Life-threatening Adverse Events (AE)
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy for patients with unresectable stage III non-small cell lung cancer.
Detailed Description
Increasing the biological effective dose (BED) of radiotherapy for non-small cell lung cancer (NSCLC) can increase local control rates and improve overall survival. Compared with conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield higher BED, shorten the total treatment time, and theoretically obtain better efficacy. However, currently, there is no optimal hypofractionated radiotherapy regimen. Based on phase I trial results, we performed this phase II trial to further evaluate the safety and preliminary efficacy of accelerated hypofractionated three-dimensional conformal radiation therapy(3-DCRT) combined with concurrent chemotherapy for patients with unresectable stage III NSCLC.
Patients with previously untreated unresectable stage III NSCLC received 3-DCRT with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. At the same time, platinum doublet chemotherapy was applied.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pathological or cytological diagnose of unresectable stage III non-small cell lung cancer
- •The Karnofsky performance status (KPS) score ≥
- •The expected survival time ≥3 months.
- •Adequate blood, liver, lungs and kidney function
- •Accessible contact information
- •Informed consent required before enrollment.
Exclusion Criteria
- •Pregnant or breastfeeding.
- •Another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years)
- •Cannot receive concurrent chemotherapy due to medical reasons.
- •Superior vena cava syndrome.
- •Severe lung diseases that affected lung function.
Outcomes
Primary Outcomes
Number of Participants with Severe and Life-threatening Adverse Events (AE)
Time Frame: Baseline to the time of intolerable toxicity(up to 1 year) or measured Progressive Disease (PD)
intolerable toxicities: severe and life-threatening adverse events (Grade III/IV in Common Terminology Criteria for Adverse Events v3.0 (CTCAE 3.0))
Secondary Outcomes
- Percentage of Participants with Progression Free Survival (PFS) at 1 Year(Baseline and 1 year)
Investigators
LIN QIANG
Professor
North China Petroleum Bureau General Hospital