Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With Non-small Cell Lung Cancer

A Phase II Study of Accelerated Hypofractionated Three-dimensional Conformal Radiation Therapy Concurrent With Chemotherapy in Unresectable Stage III Non-small Cell Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02720614

Enrollment

Registered

2016-03-28

Start date

2012-05-31

Completion date

2014-11-30

Last updated

2016-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

accelerated hypofractionated radiotherapy, three-dimensional conformal radiation therapy, concurrent radiochemotherapy

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.

Interventions

RADIATIONHypofractionated radiation/chemotherapy

Procedure: Radiation Therapy Drug: Vinorelbine Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Severe and Life-threatening Adverse Events (AE)	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

Measure	Time frame
Percentage of Participants with Progression Free Survival (PFS) at 1 Year	Baseline and 1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026