Hypofraction Radiotherapy for Locally Advanced Non-small Cell Lung Cancer
Hypofraction Radiotherapy Followed by Immune Checkpoint Inhibitors for Locally Advanced Non-small Cell Lung Cancer: A Phase I/II Trial
Anhui Provincial Hospital
36 participants
Aug 1, 2021
INTERVENTIONAL
Conditions
Summary
Definitive concurrent chemoradiotherapy followed by durvalumab (Pacific protocol) has been the standard modality for stage III locally advanced non-small cell lung cancer. In spite of the median overall survival of 47.5 months, there still existed 38.5% and 6.9% patients who finally developed intra-thorax and extra-thorax recurrence respectively in long-term follow-up. The relatively low local control rate has been the bottleneck for further improvement of overall survival. Hypofraction radiotherapy has been validated to be able to increase the local control rate in two prospective trials. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy followed by immune checkpoint inhibitors for stage III locally advanced non-small cell lung cancer.
Eligibility
Inclusion Criteria7
- -70 years old;
- Eastern Cooperative Oncology Group (ECOG) 0-1;
- Non-small cell lung cancer including squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, large-cell carcinoma;
- Wild-type of driven genes;
- Stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and d Positron Emission Tomography (PET-CT);
- Surgically unresectable or deny of surgery;
- Signature of inform consent.
Exclusion Criteria7
- Younger than 18 years old or older than 70 years old;
- ECOG>1;
- Small-cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
- Mutant type of driven genes;
- Non-stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;
- Surgically resectable;
- No signature of inform consent.
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Interventions
Patients in this arm would receive high-dose fractionated radiotherapy with 60-68Gy/15-17f with one-year immunotherapy maintenance.
Patients in this arm would receive high-dose fractionated radiotherapy with 48Gy/15-12f with one-year immunotherapy maintenance.
Locations(1)
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NCT05269485