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Clinical Trials/NCT02720614
NCT02720614CompletedPhase 2

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

LIN QIANG0 sites12 target enrollmentStarted: May 1, 2012Last updated:
Conditions

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

Sponsor
LIN QIANG
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

LIN QIANG

Professor

North China Petroleum Bureau General Hospital

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