RAPART in Locally Advanced Non-small Cell Lung Cancer Patients

Capital Medical University

Status: Enrolling

Conditions: Locally Advanced Non-small Cell Lung Cancer

Treatments: Radiation: Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology（RAPART)）; Radiation: Conventional radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07164885

GCOG0058

Details and patient eligibility

About

This is a Phase II/III randomized clinical trial of Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology (RAPART) in locally advanced non-small cell lung cancer patients. The main objective is to test the overall improvement of overall survival (OS), progression free survival (PFS), and local progression free survival (LPFS) of unresectable stage III NSCLC under standard and non-standard mixed treatment conditions compared to conventional 60Gy radiotherapy.

Enrollment: 911 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult research participants, aged over 18 years old;
• Non small cell lung cancer that requires pathological confirmation;
• All stage 3 unresectable non-small cell lung cancer, including stage correction after MDT and stage downgrading after treatment (4 → 3), and stage upregulation due to disease progression (2 → 3);
• ECOG physical condition is 0-2;
• In addition to study participants who have not received any treatment, study participants who have undergone surgery, chemotherapy, immunotherapy, and targeted therapy are also eligible for enrollment.

Exclusion criteria

• Prisoners who are not convenient for close clinical follow-up;
• Study participants with contraindications to radiation therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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911 participants in 2 patient groups

Experiment

Experimental group

Description:

RAPART technology

Treatment:

Radiation: Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology（RAPART)）

conventional radiotherapy

Active Comparator group

Description:

conventional radiotherapy 2Gy/F

Treatment:

Radiation: Conventional radiotherapy