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Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases: a Prospective, Randomized, Controlled Phase II Study

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or PET-CT confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery, or PET-CT/chest CT confirmed lung oligometastases (number of metastases ≤3, single lesion diameter ≤5cm).

• Age 18 years or older, regardless of gender.

• ECOG performance status score of 0-2.

• Serum hemoglobin ≥ 80 g/L, platelets ≥ 100,000/μL, absolute neutrophil count ≥ 1,500/μL.

• Serum creatinine ≤ 1.25 times the upper normal limit (UNL) or creatinine clearance ≥ 60 ml/min.

• Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.

• FEV1 ≥ 0.5 L.

• Normal CB6 range.

• The patient and their family agree and sign the informed consent form.

Locations
Other Locations
China
Sun yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Bo Qiu, Professor
qiubo@sysucc.org.cn
+862087343031
Backup
Hui Liu, Professor
liuhui@sysucc.org.cn
+862087343031
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2028-04-21
Participants
Target number of participants: 130
Treatments
Experimental: The study group
Patients in the study group will receive online adaptive stereotactic body radiotherapy (without PTV expansion margin). The total dose will be 45-50Gy/3-4 fractions, administered once daily. Both FBCT and 4DCT will be acquired before initiating treatment at each fraction.
Active_comparator: The control group
Patients in the control group will receive conventional standard stereotactic body radiotherapy. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired before initiating treatment at each fraction.
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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