DSBRT-1: Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05802641
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 83.8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The goal of this observational study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) with different fractionation modes for early lung cancer. The main questions it aims to answer are:

How effective are different regimens of SBRT for early lung cancer? How safe are different regimens of SBRT of SBRT for early lung cancer?

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Radiotherapy; Stereotactic Body Radiotherapy; Fractionation	Radiation: SBRT

Detailed Description

The goal of this observational study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) with different fractionation modes for early lung cancer.. This study intends to review the patients with early lung cancer receiving SBRT of 30Gy/1f or 36Gy/3f from 2018 to 2024 in our center.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Clinical Study of Stereotactic Radiotherapy With Different Fractionation Modes for Early Lung Cancer
• Actual Study Start Date: Jan 7, 2018
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
single fraction of SBRT（30Gy/1f） Participants with early lung cancer receive single fraction of SBRT（30Gy/1f).	Radiation: SBRT; Participants with early lung cancer receive single fraction (30Gy/1f) or multiple fractions of SBRT（36Gy/3f).
Multiple fractions of SBRT（36Gy/3f） Participants with early lung cancer receive multiple fractions of SBRT（36Gy/3f).	Radiation: SBRT; Participants with early lung cancer receive single fraction (30Gy/1f) or multiple fractions of SBRT（36Gy/3f).

Outcome Measures

Primary Outcome Measures

1. PFS [2025-01-01]

   The time from the date of treatment to the date of disease progression or death or last follow-up.

Secondary Outcome Measures

1. OS [2025-01-01]

   The time from the date of treatment to the date of death or last follow-up.

2. AE [2025-03-21]

   The incidence of All adverse event (AE), treatment emergent AE (TEAE), treatment-related AE (TRAE), serious AE (SAE) and radiation-related AE(rAE), the relevance and severity related with the study protocol.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

1. Signed written informed consent;

2. Male or female aged ≥ 18 years and ≤ 75 years;

3. patients with early lung cancer confirmed by pathology or clinical multidisciplinary team (MDT);

4. The ECOG PS was 0 to 1;

5. Survival time ≥3 months;

6. Laboratory results during screening must meet the following requirements:

7. Blood routine: neutrophil absolute count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days);

8. Liver function: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 2.5 times ULN in subjects without liver metastasis, and ALT and AST were less than 5 times ULN in subjects with liver metastasis.

9. Renal function: serum creatinine (Cr) ≤1.5 times ULN or Cr clearance ≥60 mL/min (Cockcroft-Gault formula), and urine protein (UPRO) &lt on routine urine test; 2+ or 24 h urinary protein quantification < 1g;

10. International standardized ratio (INR) ≤1.5 times ULN and partial prothrombin time (PTT) or activated partial thrombin time (APTT) ≤1.5 times ULN during the 7 days prior to treatment;

Exclusion Criteria:

1. any unstable systemic disease, including but not limited to active infection, congestive heart failure [New York Heart Association (NYHA) class ≥ II], severe arrhythmia requiring medical therapy, liver, kidney, or metabolic disease; Type I and type II respiratory failure;

2. other malignancies within 5 years before randomization, except adequately treated cervical carcinoma in situ, basal cell or squamous skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or papillary thyroid cancer;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of radiation oncology, Peking University Third Hospital	Peking	Beijing	China	100191

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

• Principal Investigator: Hongqing Zhuang, M.D., Department of Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT05802641
• Other Study ID Numbers: DSBRT-1
• First Posted: Apr 6, 2023
• Last Update Posted: Apr 6, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking University Third Hospital: lung cancer; Stereotactic body radiotherapy; Fractionation
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Apr 6, 2023