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

Primary Purpose

Non-small Cell Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

chest radiation(IMRT)

Concurrent chemotherapy twice a week

Concurrent chemotherapy once a week

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring lung cancer, radiotherapy, albumin bound paclitaxel

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concurrent chemotherapy Twice a Week

Concurrent chemotherapy Once a Week

Arm Description

During the 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.

Outcomes

Primary Outcome Measures

local control rate

To assess the efficacy of albumin bound paclitaxel twice a week in terms of local control rate for all patients

Secondary Outcome Measures

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

Overall Survival(OS)

To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of overall survival

Response Rate(RR)

To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of response rate

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

rate of grade 3-4 radiation esophagitis

rate of grade 3-4 radiation pneumonitis

Full Information

NCT ID

NCT04524299

First Posted

August 20, 2020

Last Updated

August 20, 2020

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04524299

Brief Title

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

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

lung cancer, radiotherapy, albumin bound paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Concurrent chemotherapy Twice a Week

Arm Type

Experimental

Arm Description

During the 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.

Arm Title

Concurrent chemotherapy Once a Week

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

chest radiation(IMRT)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Concurrent chemotherapy twice a week

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Concurrent chemotherapy once a week

Intervention Description

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.

Primary Outcome Measure Information:

Title

local control rate

Description

To assess the efficacy of albumin bound paclitaxel twice a week in terms of local control rate for all patients

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Progression-free Survival

Description

To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of progression-free survival

Time Frame

2 Years

Title

Overall Survival(OS)

Description

To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of overall survival

Time Frame

2 Years

Title

Response Rate(RR)

Description

To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of response rate

Time Frame

2 years

Title

Distant metastasis rate

Description

To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of distant metastasis rate

Time Frame

2 years

Title

rate of grade 3-4 radiation esophagitis

Time Frame

1 year

Title

rate of grade 3-4 radiation pneumonitis

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bo Qiu, Ph.D

Phone

+86-020-87343031

qiubo@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Hui Liu, Prof.

Phone

+86-020-87343031

liuhui@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Liu, Prof.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University

City

Guangzhou

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui Liu, Professor

Phone

+86-020-87343031

liuhui@sysucc.org.cn

12. IPD Sharing Statement

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

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