Clinical trial NCT04524299: Study of Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin for Locally Advanced NSCLC
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: lung cancer
radiotherapy
albumin bound paclitaxel
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: local control rate
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 2 Years
measure: Overall Survival(OS)
timeFrame: 2 Years
measure: Response Rate(RR)
timeFrame: 2 years
measure: Distant metastasis rate
timeFrame: 2 years
measure: rate of grade 3-4 radiation esophagitis
timeFrame: 1 year
measure: rate of grade 3-4 radiation pneumonitis
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, Prof.
role: PRINCIPAL_INVESTIGATOR
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