Hypofractionated Radiotherapy Followed by Hypo-boost for Local Advanced NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

Hypofractionated Radiotherapy Followed by Hypofractionated Boost With Weekly Concurrent Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: A Prospective, Single Arm Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900117
• Other study ID #: GASTO 1049
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: June 20, 2022

Study information

• Verified date: October 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Radiation:
• 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.

Drug:
• concurrent chemotherapy
Concurrent chemotherapy consists of weekly docetaxel(25mg/?) and nedaplatin(25mg/?), each of 1 day's duration.

Locations

Country	Name	City	State
China	Hui Liu	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		3 years
Secondary	overall survival		3 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