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

August 20, 2020 updated by: Hui Liu, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

  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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China, 510060
        • Recruiting
        • Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Concurrent chemotherapy Twice a Week
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.
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.

  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 of radiotherapy; D1, D4, D8 of the second stage of radiotherapy
ACTIVE_COMPARATOR: 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local control rate
Time Frame: 2 years
To assess the efficacy of albumin bound paclitaxel twice a week in terms of local control rate for all patients
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of grade 3-4 radiation esophagitis
Time Frame: 1 year
1 year
rate of grade 3-4 radiation pneumonitis
Time Frame: 1 year
1 year
Progression-free Survival
Time Frame: 2 Years
To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of progression-free survival
2 Years
Overall Survival(OS)
Time Frame: 2 Years
To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of overall survival
2 Years
Response Rate(RR)
Time Frame: 2 years
To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of response rate
2 years
Distant metastasis rate
Time Frame: 2 years
To assess the efficacy of albumin bound paclitaxel twice a week compared with once a week in terms of distant metastasis rate
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2020

Primary Completion (ANTICIPATED)

May 31, 2022

Study Completion (ANTICIPATED)

May 31, 2024

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (ACTUAL)

August 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-1066

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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