Health TrialsbyHealthPanel

RAPART in Locally Advanced Non-small Cell Lung Cancer Patients

ConditionLocally Advanced Non-small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Prisoners who are not convenient for close clinical follow-up;

Study participants with contraindications to radiation therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology（RAPART)）

    Radiation

    RAPART technology is a special combination of ART and RAPRT, with a total course limit of no more than 30 exposures. The entire course of treatment can be divided into two stages: the first stage is completely the same as the conventional radiotherapy group, with a total of 23 doses of 2 Gy per session. The second stage is the combination of ART and PAPRT. ART uses a CT or PET/CT localization simulation to be performed again during the course of treatment (usually after completing the first part of 17-19 exposures) to generate a new adaptive plan, and after completing the first stage of 23 exposures, treatment is carried out according to the new adaptive plan. RAPAT uses ERCC1/2 biomarkers to predict the patient's radiation sensitivity and determine individualized radiation dose accordingly. ERCC1/2 biomarkers divided patients into 5 different radiosensitivity groups, corresponding to 5 different radiation doses (74, 66, 62, 54, and 50 Gy).

  • Conventional radiotherapy

    Radiation

    conventional radiotherapy

Treatment groups

911 Participants
are divided into 2 treatment groups
Group A: ExperimentExperimental treatment 1 intervention
Group B: conventional radiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

overall survival

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes

1

progression-free survival

Time frame
From enrollment to 3 years after the end of treatment
2

Toxic events

Time frame
From enrollment to 3 years after treatment

Other outcomes

Sponsors and contacts

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

Capital Medical University

Lead sponsor

Source ClinicalTrials.gov
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