Study of Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin for Locally Advanced NSCLC

Study Overview
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Brief Summary
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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
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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. 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. 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.

Official Title
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A Phase II,Randomized Controlled Clinical Trial of Staged Thoracic Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin Twice a Week for Locally Advanced NSCLC

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: chest radiation(IMRT)
* Drug: Concurrent chemotherapy twice a week
* Drug: Concurrent chemotherapy once a week


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concurrent chemotherapy Twice a Week<br>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. | Radiation: chest radiation(IMRT)<br>* 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.<br>Drug: Concurrent chemotherapy twice a week<br>* 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. 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. 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<br>|
| Active Comparator: Concurrent chemotherapy Once a Week<br>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. | Radiation: chest radiation(IMRT)<br>* 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.<br>Drug: Concurrent chemotherapy once a week<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control rate | To assess the efficacy of albumin bound paclitaxel twice a week in terms of local control rate for all patients | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of progression-free survival | 2 Years | 
| Overall Survival(OS) | To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of overall survival | 2 Years | 
| Response Rate(RR) | To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of response rate | 2 years | 
| Distant metastasis rate | To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of distant metastasis rate | 2 years | 
| rate of grade 3-4 radiation esophagitis |  | 1 year | 
| rate of grade 3-4 radiation pneumonitis |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, radiotherapy, albumin bound paclitaxel