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

March 25, 2016 updated by: LIN QIANG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated radiation/chemotherapy

Hypofractionated radiation：Patients receive accelerated hypofractionated radiation: three-dimensional conformal radiation therapy (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.

Chemotherapy: Regimen 1 is as follows: vinorelbine (NVB) was administered by intravenous infusion at a dose of 25 mg/m2 on day 1 (d1) and day 8 (d8), and carboplatin (CBP) is administered at a concentration-time curve (AUC) of 5 mg/ml on d8. This treatment was repeated every 28 days. One cycle of chemotherapy is performed concurrently with the radiotherapy.

Chemotherapy: Regimen 2 is as follows: paclitaxel at 30 mg/m2 and cisplatin at 20 mg/m2 (TP) are administrated every week for 5 weeks continuously.
Radiation: Hypofractionated radiation/chemotherapy
Procedure: Radiation Therapy Drug: Vinorelbine Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
Baseline to the time of intolerable toxicity(up to 1 year) or measured Progressive Disease (PD)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LIN QIANG

Investigators

  • Study Chair: Qiang Lin, Dr, North China Petroleum Bureau General Hospital of Hebei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 25, 2016

First Posted (Estimate)

March 28, 2016

Study Record Updates

Last Update Posted (Estimate)

March 28, 2016

Last Update Submitted That Met QC Criteria

March 25, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NorthChinaPBGH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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