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

Launched by SUN YAT-SEN UNIVERSITY · Aug 20, 2020

Keywords

ClinConnect 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.

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...

Gender

ALL

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.