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NCT Number: NCT06730295

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer

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 centrally located early-stage non-small cell lung cancer (NSCLC).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Hui Liu, Doctor

CONTACT

[email protected]

+8687343657

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0), or recurrent disease (rT1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery.
  • Centrally located lung cancer.
  • 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

  • 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.

Treatment and study plan

Online adaptive SBRT

Radiation

Online adaptive SBRT (without PTV expansion margin). The total dose will be 39-42Gy/3 fractions, administered once daily. FBCT and 4DCT will be acquired.

Primary outcomes

  1. Incidence of grade 3 or higher SBRT-related toxicity

    Time frame: 1-year

    Incidence of grade 3 or higher SBRT-related toxicity

Secondary outcomes

  1. Objective response rate

    Time frame: 2 months after radiotherapy]

    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.

  2. Local control rate

    Time frame: 2-year

    The control of the local lesion after treatment.

  3. Progression-free survival

    Time frame: 2-year

    PFS measures the time from the start date of SBRT to disease progression, death from any cause or last follow up if alive.

Study contacts

Contact information is provided by the study sponsor or research team.

DaQuan Wang, Dr.

CONTACT

[email protected]

+862087343031

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer: a Prospective, Single-arm, Phase II Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 12, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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