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Moderate Hypofractionated Radiotherapy for Lung Cancer

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hypofractionated radiotherapy
Sponsored by
North China Petroleum Bureau General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Hypofractionated radiotherapy;, Radiation-reduced esophagitis;, Radiation-reduced pneumonitis;Predictor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with previously untreated advanced lung cancer were recruited, who were confirmed pathologically or cytologically.
  2. The Karnofsky performance status (KPS) score ≥60.
  3. The expected survival time was≥3 months.
  4. 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.
  5. The patients did not show abnormal electrocardiogram (ECG) results.
  6. They did not have other combined diseases that required hospitalization.
  7. Informed consent required before enrollment.

Exclusion Criteria:

  1. Patients who were pregnant or breastfeeding.
  2. 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.
  3. Superior vena cava syndrome.
  4. Syndrome and severe lung diseases that affected lung function were excluded.

Sites / Locations

  • North China Petroleum Bureau General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated radiotherapy

Arm Description

The patients received daily accelerated radiotherapy with a total dose of 60Gy, delivered at 3Gy per fraction, five fractions per week, completed within 4 weeks.

Outcomes

Primary Outcome Measures

Incidence of grade III and above radiation-reduced esophagitis
Incidence of grade III and above radiation-reduced esophagitis
Incidence of grade III and above radiation-reduced pneumonitis
Incidence of grade III and above radiation-reduced pneumonitis

Secondary Outcome Measures

Objective Response Rate
ORR
Local Control Rate
LCR
Progression Free Survival
PFS
Median Survival Time
MST
Overall Survival
OS

Full Information

First Posted
February 3, 2019
Last Updated
March 22, 2023
Sponsor
North China Petroleum Bureau General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03833193
Brief Title
Moderate Hypofractionated Radiotherapy for Lung Cancer
Official Title
Moderate Hypofractionated(3Gy/f) Radiotherapy for Advanced Lung Cancer: a Retrospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North China Petroleum Bureau General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Hypofractionated radiotherapy;, Radiation-reduced esophagitis;, Radiation-reduced pneumonitis;Predictor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypofractionated radiotherapy
Arm Type
Experimental
Arm Description
The patients received daily accelerated radiotherapy with a total dose of 60Gy, delivered at 3Gy per fraction, five fractions per week, completed within 4 weeks.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated radiotherapy
Intervention Description
Radiation: Hypofractionated radiotherapy at 3Gy/f
Primary Outcome Measure Information:
Title
Incidence of grade III and above radiation-reduced esophagitis
Description
Incidence of grade III and above radiation-reduced esophagitis
Time Frame
three years
Title
Incidence of grade III and above radiation-reduced pneumonitis
Description
Incidence of grade III and above radiation-reduced pneumonitis
Time Frame
three years
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
ORR
Time Frame
three years
Title
Local Control Rate
Description
LCR
Time Frame
three years
Title
Progression Free Survival
Description
PFS
Time Frame
three years
Title
Median Survival Time
Description
MST
Time Frame
three years
Title
Overall Survival
Description
OS
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 ≥60. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
QIANG LIN, Dr
Phone
+86-177-177-37955
Ext
+86-317-272195
Email
billhappy001@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
YAN-HUA BI, Master
Phone
+86-18931705808
Ext
+86-3172723053
Email
zyy_byh@petrochina.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
QIANG LIN, Dr
Organizational Affiliation
North China Petroleum Bureau General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
North China Petroleum Bureau General Hospital
City
Cangzhou
State/Province
HE BEI
ZIP/Postal Code
062552
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
QIANG LIN, Dr
Phone
+86-317-272-1951
Email
billhappy001@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Moderate Hypofractionated Radiotherapy for Lung Cancer

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