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Clinical Trials/NCT03833193
NCT03833193
Recruiting
Not Applicable

Moderate Hypofractionated(3Gy/f) Radiotherapy for Advanced Lung Cancer: a Retrospective Study.

North China Petroleum Bureau General Hospital1 site in 1 country60 target enrollmentNovember 1, 2016
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
North China Petroleum Bureau General Hospital
Enrollment
60
Locations
1
Primary Endpoint
Incidence of grade III and above radiation-reduced esophagitis
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia of patients with advanced lung cancer treated with moderate hypofractionated (3Gy/f) radiotherapy, and their predictors. Efficacies are also evaluated.

Detailed Description

Radiotherapy plays an irreplaceable role in lung cancer. However, due to the long duration of conventional fractionation irradiation, tumor cells will accelerate repopulation after 3 to 4 weeks during radiotherapy, resulting in decreased efficacy. Hypofractionated radiation is increasingly used in radiotherapy of lung cancer. It can shorten the overall treatment time, and can potentially reduce the effect of tumor accelerated repopulation. Compared with conventional radiotherapy, hypofractionated radiotherapy can theoretically obtain a higher biological effective dose (BED). The application of Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SABR) in advanced or central lung cancer is restricted when the tumors are adjacent to important organs. Moderate hypofractionated radiotherapy can not only shorten the overall total treatment time, but also reduce the severe toxicities. It is widely used in lung cancer nowadays. However, most data of the tolerated doses for normal tissue and organs comes from conventional radiotherapy. Whether or not it is suitable for hypofractionated radiotherapy has not been determined. In our study, the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia, as well as their predictors, were obtained by retrospective analysis of patients received moderate hypofractionated radiotherapy of 3Gy/f. At the same time, the efficacies of this scheme are also evaluated.

Registry
clinicaltrials.gov
Start Date
November 1, 2016
End Date
March 1, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
North China Petroleum Bureau General Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with previously untreated advanced lung cancer were recruited, who were confirmed pathologically or cytologically.
  • The Karnofsky performance status (KPS) score ≥
  • The expected survival time was≥3 months.
  • The laboratory examination results showed a neutrophil count ≥2.0 × 109, a hemoglobin level ≥100 g/L, a platelet count ≥100 × 109, and enough liver and kidney functions.
  • The patients did not show abnormal electrocardiogram (ECG) results.
  • They did not have other combined diseases that required hospitalization.
  • Informed consent required before enrollment.

Exclusion Criteria

  • Patients who were pregnant or breastfeeding.
  • Patients who had 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), could not receive concurrent chemotherapy due to medical reasons.
  • Superior vena cava syndrome.
  • Syndrome and severe lung diseases that affected lung function were excluded.

Outcomes

Primary Outcomes

Incidence of grade III and above radiation-reduced esophagitis

Time Frame: three years

Incidence of grade III and above radiation-reduced esophagitis

Incidence of grade III and above radiation-reduced pneumonitis

Time Frame: three years

Incidence of grade III and above radiation-reduced pneumonitis

Secondary Outcomes

  • Objective Response Rate(three years)
  • Local Control Rate(three years)
  • Progression Free Survival(three years)
  • Median Survival Time(three years)
  • Overall Survival(three years)

Study Sites (1)

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