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Completed

NCT Number: NCT02720614

Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypofractionated radiation/chemotherapy

Radiation

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

Primary outcomes

  1. 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

  1. Percentage of Participants with Progression Free Survival (PFS) at 1 Year

    Time frame: Baseline and 1 year

Sponsors and collaborators

Lead sponsor

LIN QIANG

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 28, 2016
Registry last updated
Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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