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

NCT04524299 | Unknown Phase 2

• 1 other identifier: GASTO-1066
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

lung cancer; radiotherapy; albumin bound paclitaxel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Progression-free Survival

  2 Years

• Overall Survival(OS)

  2 Years

• Response Rate(RR)

  2 years

• Distant metastasis rate

  2 years

• rate of grade 3-4 radiation esophagitis

  1 year

Study Arms (2)

Concurrent chemotherapy Twice a Week

EXPERIMENTAL

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); Drug: Concurrent chemotherapy twice a week

Concurrent chemotherapy Once a Week

ACTIVE COMPARATOR

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); Drug: Concurrent chemotherapy once a week

Interventions

chest radiation(IMRT) RADIATION

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 Once a Week; Concurrent chemotherapy Twice a Week

Concurrent chemotherapy twice a week DRUG

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

Concurrent chemotherapy Twice a Week

Concurrent chemotherapy once a week DRUG

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.

Concurrent chemotherapy Once a Week

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, 510060, China

RECRUITING

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hui Liu, Prof.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Qiu, Ph.D

CONTACT

+86-020-87343031; qiubo@sysucc.org.cn

Hui Liu, Prof.

CONTACT

+86-020-87343031; liuhui@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Study Start: June 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2024
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

CN (1)