Study of Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin for Locally Advanced NSCLC
NCT ID: NCT04524299
Last Updated: 2020-08-24
Study Results
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Basic Information
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UNKNOWN
PHASE2
160 participants
INTERVENTIONAL
2020-06-01
2024-05-31
Brief Summary
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Detailed Description
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Radiotherapy:
All patients will receive intensity modulated radiotherapy (IMRT) once a day, 5 days a week. The first stage: DT 3000 cGy / 6 FX; the second stage, DT 3500 cGy / 7 FX. Or: the first segment: DT 4000 cGy / 10 FX; the second segment DT 2400 cGy / 6 FX. The interval between two stages of radiotherapy was 4 weeks.
Concurrent chemotherapy:
The patients were randomly divided into two groups and received one of the following concurrent chemotherapy regimens:
Group A: during the same period of radiotherapy, 30 mg / m2 albumin bound paclitaxel was intravenously infused twice a week for 0.5 hours, and nedaplatin 10 mg / m2 twice a week for 0.5 hours.
1. When the radiotherapy dose was 3000 cGy / 6 FX + DT 3500 cGy / 7 FX, the infusion time was D1, D4, D8 of the first stage of radiotherapy; D1, D4, D8 of the second stage of radiotherapy.
2. When the radiotherapy dose was 4000 cGy / 10 FX + DT 2400 cGy / 6 FX, the infusion time was D1, D4, D8, D11 of the first stage radiotherapy, and D1, D4, D8 of the second stage radiotherapy.
Group B: during the same period of radiotherapy, albumin bound paclitaxel (50 mg / m2) was intravenously infused once a week for 0.5 hours; nedaplatin (25 mg / m2) was intravenously infused once a week for 0.5 hours. The infusion time was D1, D8 of the first radiotherapy and D1, D8 of the second radiotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Concurrent chemotherapy Twice a Week
During the period of radiotherapy, 30 mg / m2 albumin bound paclitaxel was intravenously infused twice a week for 0.5 hours, and nedaplatin 10 mg / m2 twice a week for 0.5 hours.
chest radiation(IMRT)
Patients will receive intensity modulated radiotherapy (IMRT) once a day, 5 days a week. The first stage: DT 3000 cGy / 6 FX; the second stage, DT 3500 cGy / 7 FX. Or: the first segment: DT 4000 cGy / 10 FX; the second segment DT 2400 cGy / 6 FX. The interval between two stages of radiotherapy was 4 weeks.
Concurrent chemotherapy twice a week
During the same period of radiotherapy, 30 mg / m2 albumin bound paclitaxel was intravenously infused twice a week for 0.5 hours, and nedaplatin 10 mg / m2 twice a week for 0.5 hours.
1. When the radiotherapy dose was 3000 cGy / 6 FX + DT 3500 cGy / 7 FX, the infusion time was D1, D4, D8 of the first stage of radiotherapy; D1, D4, D8 of the second stage of radiotherapy.
2. When the radiotherapy dose was 4000 cGy / 10 FX + DT 2400 cGy / 6 FX, the infusion time was D1, D4, D8, D11 of the first stage of radiotherapy; D1, D4, D8 of the second stage of radiotherapy
Concurrent chemotherapy Once a Week
During the same period of radiotherapy, albumin bound paclitaxel (50 mg / m2) was intravenously infused once a week for 0.5 hours; nedaplatin (25 mg / m2) was intravenously infused once a week for 0.5 hours.
chest radiation(IMRT)
Patients will receive intensity modulated radiotherapy (IMRT) once a day, 5 days a week. The first stage: DT 3000 cGy / 6 FX; the second stage, DT 3500 cGy / 7 FX. Or: the first segment: DT 4000 cGy / 10 FX; the second segment DT 2400 cGy / 6 FX. The interval between two stages of radiotherapy was 4 weeks.
Concurrent chemotherapy once a week
During the same period of radiotherapy, albumin bound paclitaxel (50 mg / m2) was intravenously infused once a week for 0.5 hours; nedaplatin (25 mg / m2) was intravenously infused once a week for 0.5 hours. The infusion time was D1, D8 of the first radiotherapy and D1, D8 of the second radiotherapy.
Interventions
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chest radiation(IMRT)
Patients will receive intensity modulated radiotherapy (IMRT) once a day, 5 days a week. The first stage: DT 3000 cGy / 6 FX; the second stage, DT 3500 cGy / 7 FX. Or: the first segment: DT 4000 cGy / 10 FX; the second segment DT 2400 cGy / 6 FX. The interval between two stages of radiotherapy was 4 weeks.
Concurrent chemotherapy twice a week
During the same period of radiotherapy, 30 mg / m2 albumin bound paclitaxel was intravenously infused twice a week for 0.5 hours, and nedaplatin 10 mg / m2 twice a week for 0.5 hours.
1. When the radiotherapy dose was 3000 cGy / 6 FX + DT 3500 cGy / 7 FX, the infusion time was D1, D4, D8 of the first stage of radiotherapy; D1, D4, D8 of the second stage of radiotherapy.
2. When the radiotherapy dose was 4000 cGy / 10 FX + DT 2400 cGy / 6 FX, the infusion time was D1, D4, D8, D11 of the first stage of radiotherapy; D1, D4, D8 of the second stage of radiotherapy
Concurrent chemotherapy once a week
During the same period of radiotherapy, albumin bound paclitaxel (50 mg / m2) was intravenously infused once a week for 0.5 hours; nedaplatin (25 mg / m2) was intravenously infused once a week for 0.5 hours. The infusion time was D1, D8 of the first radiotherapy and D1, D8 of the second radiotherapy.
Eligibility Criteria
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Inclusion Criteria
* There were measurable diseases according to recist1.1.
* Non operative stage III (AJCC / UICC eighth edition stage).
* When the lowest dose of radiotherapy was 60Gy, V20 \> = 35% in both lungs.
* 18 years old or above, under 75 years old, regardless of gender.
* ECoG physical status score (see Annex 1) was 0-1.
* Initial treatment or chemotherapy.
* There was no previous chest radiotherapy, immunotherapy or biotherapy.
* Neutrophil absolute value ≥ 2000 cells / mm3, platelet ≥ 100000 cells / mm3
* Serum creatinine ≤ 1.25 times ULN or creatinine clearance rate ≥ 60 ml / min.
* Serum bilirubin ≤ 1.5 times ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN.
* CB6 normal range.
* The patient and his family members agreed and signed the informed consent.
Exclusion Criteria
* Any other disease or condition is contraindication to chemotherapy (e.g. active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).
* Pregnant or lactating women, women who did not undergo a pregnancy test (within 14 days before the first administration), and pregnant women.
* Bleeding tendency.
* Participants in other clinical trials within 30 days before the experiment.
* Drug addiction, long-term alcoholism and AIDS patients.
* There are uncontrollable seizures or loss of self-control due to mental illness.
* Patients with severe allergic history or specific constitution.
* The researchers consider that it is not suitable to participate in this experiment.
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, Prof.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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GASTO-1066
Identifier Type: -
Identifier Source: org_study_id
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