Clinical trial NCT02720614: Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With Non-small Cell Lung Cancer
Official title: A Phase II Study of Accelerated Hypofractionated Three-dimensional Conformal Radiation Therapy Concurrent With Chemotherapy in Unresectable Stage III Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: accelerated hypofractionated radiotherapy
three-dimensional conformal radiation therapy
concurrent radiochemotherapy
Lead sponsor: North China Petroleum Bureau General Hospital
Sponsor class: OTHER
First posted: 2016-03-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Pathological or cytological diagnose of unresectable stage III non-small cell lung cancer
* The Karnofsky performance status (KPS) score ≥70.
* 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.

Primary outcomes:
measure: Number of Participants with Severe and Life-threatening Adverse Events (AE)
timeFrame: Baseline to the time of intolerable toxicity(up to 1 year) or measured Progressive Disease (PD)
Secondary outcomes:
measure: Percentage of Participants with Progression Free Survival (PFS) at 1 Year
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
Study officials:
affiliation: North China Petroleum Bureau General Hospital of Hebei Medical University
name: Qiang Lin, Dr
role: STUDY_CHAIR
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