Study of Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin for Locally Advanced NSCLC
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Radiation: chest radiation(IMRT)Drug: Concurrent chemotherapy once a weekDrug: Concurrent chemotherapy twice a week
- Registration Number
- NCT04524299
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
This phase II randomized study is to investigate the efficacy and toxicity of fractional thoracic radiotherapy combined with albumin bound paclitaxel and nedaplatin twice a week in the treatment of locally advanced non-small cell lung cancer compared with weekly chemotherapy.
- Detailed Description
This phase II randomized study is to investigate the efficacy and toxicity of fractional thoracic radiotherapy combined with albumin bound paclitaxel and nedaplatin twice a week in the treatment of locally advanced non-small cell lung cancer compared with weekly chemotherapy.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- Histologically confirmed non-small cell lung cancer.
- 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.
- There were other malignant tumors in the past or during treatment, except for skin non melanoma or cervical carcinoma in situ.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Concurrent chemotherapy Once a Week chest radiation(IMRT) 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. Concurrent chemotherapy Once a Week 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. Concurrent chemotherapy Twice a Week chest radiation(IMRT) 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. Concurrent chemotherapy Twice a Week 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.
- Primary Outcome Measures
Name Time Method local control rate 2 years To assess the efficacy of albumin bound paclitaxel twice a week in terms of local control rate for all patients
- Secondary Outcome Measures
Name Time Method Progression-free Survival 2 Years To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of progression-free survival
Overall Survival(OS) 2 Years To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of overall survival
rate of grade 3-4 radiation pneumonitis 1 year Response Rate(RR) 2 years To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of response rate
Distant metastasis rate 2 years To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of distant metastasis rate
rate of grade 3-4 radiation esophagitis 1 year
Trial Locations
- Locations (1)
Sun Yat-sen University
🇨🇳Guangzhou, China