Eliminating PTV Margins in Lung Cancer Treatment

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

This study is testing if removing certain safety margins during a specific type of lung cancer radiation treatment can help patients feel better and have fewer side effects compared to the standard method.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06542159 on ClinicalTrials.gov

What this trial studies

This study explores the safety and efficacy of removing planning target volume (PTV) margins in online adaptive stereotactic body radiotherapy (SBRT) for patients with early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases. Participants will be randomly assigned to receive either online adaptive SBRT without PTV margins or conventional SBRT. The study aims to determine if this approach can improve treatment outcomes while minimizing toxicity. Regular follow-ups will assess the safety and effectiveness of the treatments.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with untreated early-stage NSCLC or pulmonary oligometastases who are inoperable or unwilling to undergo surgery.

Not a fit: Patients with tumors exhibiting bronchial invasion or other conditions contraindicating radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more precise and less toxic treatment options for patients with early-stage lung cancer.

How similar studies have performed: While the concept of adaptive radiotherapy is gaining traction, this specific approach of eliminating PTV margins is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Tumors with bronchial invasion are excluded.
* Any other disease or condition that contraindicates radiotherapy (e.g., active infections, within 6 months post-myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmias).
* Pregnant or breastfeeding women, women who have not undergone pregnancy testing, and pregnant individuals.
* Individuals with substance abuse issues, chronic alcoholism, or AIDS.
* Individuals with uncontrollable seizures or loss of self-control due to psychiatric disorders.
* Individuals with a history of severe allergies or specific sensitivities.

Where this trial is running

Guangzhou, Guangdong

• Sun yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Hui Liu, Professor — Sun yat-sen universtiy cancer center
• Study coordinator: Bo Qiu, Professor

Conditions Adaptive Radiotherapy; Stereotactic Body Radiotherapy; Non-small Cell Lung Cancer; Lung Oligometastases; Toxicity; Online adaptive radiotherapy; Stereotactic body radiotherapy; Lung oligometastases