Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC
Locally Advanced Lung Carcinoma
About this trial
This is an interventional treatment trial for Locally Advanced Lung Carcinoma focused on measuring Locally advanced non-small cell lung cancer, Definitive hypofractionated chemoradiotherapy, Fraction dose escalation, Consolidation immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Non-small cell lung cancer confirmed by histology.
- Tumor size is measured according to RECIST standard.
- Unresectable stage IIIA (N2) and IIIB/IIIC, confirmed by PET-CT/or chest and abdomen CT, brain MRI, and whole body bone scan.
- 18-75 years old, regardless of gender.
- The ECOG score is 0-1.
- Newly treated or underwent neoadjuvant chemotherapy and/or immunotherapy.
- Have not received chest radiotherapy in the past.
- Serum hemoglobin ≥10 mg/dL, platelets ≥100000/μL, absolute neutrophil count ≥1500/μL.
- Serum creatinine ≤1.25 times 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>1 L.
- CB6 normal range.
- The patient and his family members agree and sign an informed consent form.
Exclusion Criteria:
- Other malignant tumors in the past or during treatment, except for non-melanoma of the skin or carcinoma in situ of the cervix.
- Any other diseases or conditions are contraindications to chemotherapy (such as active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).
- Pregnant or breastfeeding women, women who have not undergone a pregnancy test (within 14 days before the first dose), and pregnant women.
- Those who are pregnant, breastfeeding or have fertility but have not taken contraceptive measures.
- People with bleeding tendency.
- Those who participated in other clinical trials within 30 days before participating in this experiment.
- Drug addiction, long-term alcoholism, and AIDS patients.
- People with uncontrollable seizures or loss of self-control due to mental illness.
- People with a history of severe allergies or specific physique.
- The researcher believes that the patient is inappropriate to participate in this trial.
Exit criteria
- The treatment cannot be carried out in accordance with the requirements of the research protocol;
- The patient has an allergic reaction ≥ grade 4 or a serious adverse reaction to the study drug;
- The patient is pregnant or has not used adequate contraceptive measures;
- The researcher judges that the patient should not continue to participate the clinical trial;
- The subject asked to withdraw.
Sites / Locations
- Sun yat-sen University Cancer Center
Arms of the Study
Arm 1
Experimental
Split-course adaptive HRT-CHT
In keeping the same total radiation dose (60Gy), we escalate the fraction dose to find the maximum tolerable fraction dose. Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course,DT 1500cGy/5 daily fractions/300cGy in the second course; Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course, DT 2000cGy/5 daily fractions/400cGy in the second course; Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course, DT 3000cGy/6 daily fractions/500cGy in the second course. RT is delivered using the IMRT technique with daily cone-beam CT image guidance. The dose limitation of organ at risk (OAR) are shown in Table 1. Patients receive a weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT. Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.