Hypofractionated Radiotherapy Followed by Hypo-boost for Local Advanced NSCLC

NCT03900117 | Completed Phase 2 DMC

• 1 other identifier: GASTO 1049
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the safety and efficacy of hypofractionated radiotherapy followed by hypo-boost combined with concurrent weekly chemotherapy in unresectable LA-NSCLC patients.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer; hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  3 years

Secondary Outcomes (4)

• overall survival

  3 years

• response rate

  2 months

• rate of grade 3-4 radiation esophagitis

  1 year

• rate of grade 3-4 radiation pneumonitis

  1 year

Study Arms (1)

split-course radiotherapy

EXPERIMENTAL

The radiotherapy is delivered using simultaneous integrated boost (SIB)-intensity-modulated radiotherapy (IMRT). Patients are irradiation at a palliative dose at the initial course: 40Gy/10f to gross tumor. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is re-simulated. The residual tumor was then treated with the second course of radiotherapy. A dose of 28Gy/7f is delivered to the residue tumor. Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.

Radiation: split-course radiotherapy; Drug: concurrent chemotherapy

Interventions

split-course radiotherapy RADIATION

Patients are irradiation at a palliative dose at the initial course: 40Gy/10f to PTV-GTV. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is repositioned and scanned. The residual tumor was then treated with the second course of radiotherapy. A dose of 28Gy/7f is delivered to the residue tumor.

split-course radiotherapy

concurrent chemotherapy DRUG

Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.

split-course radiotherapy

Eligibility Criteria

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

You may qualify if:

• Pathologic confirmation of NSCLC.
• Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Unresectable phase IIIA(N2) and IIIB lung cancer confirmed by PET/CT, CT or MRI.
• Whole lung V20\>=35% when giving 60Gy which is the minimum dose of radical irradiation.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Previously treated with chemotherapy or treatment-naive
• No previous chest radiotherapy, immunotherapy or biotherapy
• Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
• Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
• Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
• FEV1 \>0.8 L
• CB6 within normal limits
• patients and their family signed the informed consents

You may not qualify if:

• Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
• Contraindication for chemotherapy
• Malignant pleural or pericardial effusion.
• Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
• Women who has the probability of pregnancy without contraception
• Tendency of hemorrhage
• In other clinical trials within 30 days
• Addicted in drugs or alcohol, AIDS patients
• Uncontrollable seizure or psychotic patients without self-control ability
• Severe allergy or idiosyncrasy
• Not suitable for this study judged by researchers

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Hui Liu

Guangzhou, Guangdong, 510000, China

Location

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  BACKGROUND

• Zhou R, Qiu B, Xiong M, Liu Y, Peng K, Luo Y, Wang D, Liu F, Chen N, Guo J, Zhang J, Huang X, Rong Y, Liu H. Hypofractionated Radiotherapy followed by Hypofractionated Boost with weekly concurrent chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: Results of A Prospective Phase II Study (GASTO-1049). Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):387-399. doi: 10.1016/j.ijrobp.2023.04.021. Epub 2023 Apr 25.

  PMID: 37100160 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Hui Liu, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 2, 2019
• Study Start: March 1, 2019
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

CN (1)