Hypofractionated Radiotherapy Followed by Hypo-boost for Local Advanced NSCLC

NCT ID: NCT03900117

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2022-06-20

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.

Detailed Description

Patients receive four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, concurrent with split-course thoracic radiotherapy of 40 Gy/10 fractions and 28 Gy/7 fractions administered in the first and second courses, respectively, with one-month break. 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. 4.0.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

split-course radiotherapy

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.

Group Type: EXPERIMENTAL

split-course radiotherapy

Intervention Type: 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.

concurrent chemotherapy

Intervention Type: DRUG

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

Interventions

split-course radiotherapy

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.

Intervention Type: RADIATION

concurrent chemotherapy

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Hui Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Liu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Hui Liu

Guangzhou, Guangdong, China

Countries

China

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Other Identifiers

GASTO 1049

Identifier Type: -

Identifier Source: org_study_id