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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

ConditionsAdaptive RadiotherapyStereotactic Body RadiotherapyNon-small Cell Lung CancerLung OligometastasesToxicity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Online adaptive SBRT

    Radiation

    Online adaptive SBRT (without PTV expansion margin). The total dose will be 45-50Gy/3-4 fractions, administered once daily. FBCT and 4DCT will be acquired.

  • Conventional SBRT

    Radiation

    SBRT with PTV expansion. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: The study groupExperimental treatment 1 intervention
Group B: The control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of grade 2 or higher respiratory toxicity

Incidence of grade 2 or higher respiratory toxicity

Time frame
1 year

Secondary outcomes

1

Objective response rate

Objective Response Rate (ORR) is defined as the proportion of patients whose tumor size decreases to a pre-specified value and is maintained for a certain period of time during cancer treatment. It includes the number of patients with Complete Response (CR) and Partial Response (PR) as a percentage of the total number of evaluable cases.

Time frame
2 months after radiotherapy
2

Local control rate

The control of the local lesion after treatment.

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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