Moderate Hypofractionated Radiotherapy for Lung Cancer

• Sponsor: North China Petroleum Bureau General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03833193
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 69.9
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Radiation: Hypofractionated radiotherapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Moderate Hypofractionated(3Gy/f) Radiotherapy for Advanced Lung Cancer: a Retrospective Study.
• Actual Study Start Date: Nov 1, 2016
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: Aug 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of grade III and above radiation-reduced esophagitis [three years]

   Incidence of grade III and above radiation-reduced esophagitis

2. Incidence of grade III and above radiation-reduced pneumonitis [three years]

   Incidence of grade III and above radiation-reduced pneumonitis

Secondary Outcome Measures

1. Objective Response Rate [three years]

   ORR

2. Local Control Rate [three years]

   LCR

3. Progression Free Survival [three years]

   PFS

4. Median Survival Time [three years]

   MST

5. Overall Survival [three years]

   OS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North China Petroleum Bureau General Hospital	Cangzhou	HE BEI	China	062552

Sponsors and Collaborators

• North China Petroleum Bureau General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: North China Petroleum Bureau General Hospital
• ClinicalTrials.gov Identifier: NCT03833193
• Other Study ID Numbers: NorthChinaPBGHA
• First Posted: Feb 6, 2019
• Last Update Posted: Mar 4, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by North China Petroleum Bureau General Hospital: Hypofractionated radiotherapy;; Radiation-reduced esophagitis;; Radiation-reduced pneumonitis;Predictor
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Mar 4, 2021