Split-course Hypofractionated Radiotherapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Split-course Hypofractionated Radiotherapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04212052
• Other study ID #: GASTO 1052
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase II study is to determine the efficacy of split-course thoracic radiotherapy plus concurrent chemotherapy with or without consolidation immunotherapy for patients with local advanced non-small cell lung cancer.

Description:

This Phase II study is to determine the efficacy of split-course thoracic radiotherapy plus concurrent chemotherapy with or without consolidation immunotherapy for local advanced non-small cell lung cancer patients.

Patients were treated with hypo-RT (30Gy in 6 fractions) followed by hypo-boost (30Gy in 6 fractions) combined with concurrent weekly chemotherapy (docetaxel 25 mg/m2 and cisplatin 25 mg/m2). Consolidation immunotherapy were recommended for those without disease progression or persistent grade2+ toxicities following radiotherapy. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. Progression-free survival will be calculated using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 5.0.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 31, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed non-small cell lung cancer (NSCLC) by bronchoscopy, CT-guided biopsy, and endobronchial ultrasonography

• Unresectable stage III disease based on the seventh edition of the TNM (tumor, node, metastases) staging system proposed by the American Joint Committee on Cancer

• Measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;

• Charlson Comorbidity Index score =4

• 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

• CB6 within normal limits

• patients and their family signed the informed consents

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Radiation:
• split-course radiotherapy
The radiotherapy is delivered using simultaneous integrated boost (SIB)-intensity-modulated radiotherapy (IMRT). The dose of 30Gy with a fraction dose of 5Gy was delivered to PTV-GTV as the hypo-RT course. Patients were eligible to receive the hypo-boost when there was no disease progression and no persistent =G2 treatment-related toxicities. For patients with persistent =G2 toxicities, a re-evaluation was planned every 2 weeks to determine whether they were qualified to receive the hypoboost. All eligible patients underwent a repeat 4DCT simulation scan to reformulate the adaptive radiation therapy plan. The adaptive plan of the hypo-boost was delivered to the residual tumor (PTV-GTV-residual) at a dose of 30Gy in 6 fractions (5 Gy per fraction).

Drug:
• concurrent chemotherapy
Patients received a weekly infusion of docetaxel (25 mg/m2) and cisplatin (25 mg/m2) concurrent with hypo-RT and hypo-boost therapy. Intended chemotherapy included 4 cycles throughout the course of treatment.
• consolidation immunotherapy
Patients without disease progression or persistent grade2+ toxicities after thoracic radiotherapy were recommended to receive consolidation immunotherapy

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 (48)

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		2 year
Secondary	Overall survival		2 years
Secondary	response rate		2 months
Secondary	rate of grade 3-4 radiation esophagitis		1 year
Secondary	rate of grade 3-4 radiation pneumonitis		1 year