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

NCT04212052 | Completed Phase 2 DMC

• 1 other identifier: GASTO 1052
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer; Split-course radiotherapy; consolidation immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  2 year

Secondary Outcomes (4)

• Overall survival

  2 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). 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). 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.

Radiation: split-course radiotherapy; Drug: concurrent chemotherapy; Drug: consolidation immunotherapy

Interventions

split-course radiotherapy RADIATION

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).

split-course radiotherapy

concurrent chemotherapy DRUG

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.

split-course radiotherapy

consolidation immunotherapy DRUG

Patients without disease progression or persistent grade2+ toxicities after thoracic radiotherapy were recommended to receive consolidation immunotherapy

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:

• 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

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)

Sun Yat-sen University

Guangzhou, 510060, China

Location

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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: December 24, 2019
• First Posted: December 26, 2019
• Study Start: July 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: December 31, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CN (1)