Status:
UNKNOWN
Study of Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin for Locally Advanced NSCLC
Lead Sponsor:
Sun Yat-sen University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 lo...
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 lo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04524299
Start Date
June 1 2020
End Date
May 31 2024
Last Update
August 24 2020
Active Locations (1)
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1
Sun Yat-sen University
Guangzhou, China, 510060