Moderate Hypofractionated Radiotherapy for Lung Cancer

NCT03833193 | Unknown

• 1 other identifier: NorthChinaPBGHA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Hypofractionated radiotherapy;; Radiation-reduced esophagitis;; Radiation-reduced pneumonitis;Predictor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 Arms (1)

Hypofractionated radiotherapy

EXPERIMENTAL

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

Interventions

Hypofractionated radiotherapy RADIATION

Radiation: Hypofractionated radiotherapy at 3Gy/f

Hypofractionated radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North China Petroleum Bureau General Hospital: lead

Study Sites (1)

North China Petroleum Bureau General Hospital

Cangzhou, Hebei, 062552, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• QIANG LIN, Dr

  North China Petroleum Bureau General Hospital

  STUDY DIRECTOR

Central Study Contacts

QIANG LIN, Dr

CONTACT

+86-177-177-37955; billhappy001@163.com

YAN-HUA BI, Master

CONTACT

+86-18931705808; zyy_byh@petrochina.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2019
• First Posted: February 6, 2019
• Study Start: November 1, 2016
• Primary Completion: May 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)