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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04524299
• Other study ID #: GASTO-1066
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2020
• Source: Sun Yat-sen University
• Contact: Bo Qiu, Ph.D
• Phone: +86-020-87343031
• Email: qiubo[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• chest radiation(IMRT)
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.

Drug:
• Concurrent chemotherapy twice a week
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
• Concurrent chemotherapy once a week
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.

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	rate of grade 3-4 radiation esophagitis		1 year
Secondary	rate of grade 3-4 radiation pneumonitis		1 year