Moderate Hypofractionated Radiotherapy for Lung Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: Hypofractionated radiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: QIANG LIN, Dr; Phone Number: +86-317-272195 +86-177-177-37955; Email: billhappy001@163.com
• Study Contact Backup: Name: YAN-HUA BI, Master; Phone Number: +86-3172723053 +86-18931705808; Email: zyy_byh@petrochina.com.cn

Study Locations

• China
  • HE BEI
    • Cangzhou, HE BEI, China, 062552
      • Recruiting
      • North China Petroleum Bureau General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypofractionated radiotherapy; 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.	Radiation: Hypofractionated radiotherapy; Radiation: Hypofractionated radiotherapy at 3Gy/f

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grade III and above radiation-reduced esophagitis	Incidence of grade III and above radiation-reduced esophagitis	three years
Incidence of grade III and above radiation-reduced pneumonitis	Incidence of grade III and above radiation-reduced pneumonitis	three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	ORR	three years
Local Control Rate	LCR	three years
Progression Free Survival	PFS	three years
Median Survival Time	MST	three years
Overall Survival	OS	three years

Collaborators and Investigators

• Sponsor: North China Petroleum Bureau General Hospital
• Investigators: Study Director: QIANG LIN, Dr, North China Petroleum Bureau General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: February 3, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Hypofractionated radiotherapy;; Radiation-reduced esophagitis;; Radiation-reduced pneumonitis;Predictor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: NorthChinaPBGHA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No