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

• Status: Recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

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.