Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC
NCT ID: NCT04951063
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2021-06-01
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
1. Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course，DT 1500cGy/5 daily fractions/300cGy in the second course;
2. Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course， DT 2000cGy/5 daily fractions/400cGy in the second course;
3. 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.
Hypofractionated radiotherapy
Split-course adaptive HRT-CHT is administered at the following three dose levels:
1. Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course，DT 1500cGy/5 daily fractions/300cGy in the second course;
2. Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course， DT 2000cGy/5 daily fractions/400cGy in the second course;
3. Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course， DT 3000cGy/6 daily fractions/500cGy in the second course.
Concurrent chemotherapy
weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT
Consolidation immunotherapy
Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.
Interventions
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Hypofractionated radiotherapy
Split-course adaptive HRT-CHT is administered at the following three dose levels:
1. Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course，DT 1500cGy/5 daily fractions/300cGy in the second course;
2. Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course， DT 2000cGy/5 daily fractions/400cGy in the second course;
3. Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course， DT 3000cGy/6 daily fractions/500cGy in the second course.
Concurrent chemotherapy
weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT
Consolidation immunotherapy
Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Hui Liu
Professor
Principal Investigators
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Hui Liu, Professor
Role: PRINCIPAL_INVESTIGATOR
Sun yat-sen universtiy cancer center
Locations
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Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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References
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Other Identifiers
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GASTO-1080
Identifier Type: -
Identifier Source: org_study_id