Study of Split-course Chemoradiotherapy For Locally Advanced None-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Prospective Phase Ⅱ Study of Split-course Chemoradiotherapy For Locally Advanced None-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573506
• Other study ID #: GASTO1011
• Status: Completed
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: March 2020

Study information

• Verified date: April 2020
• 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 irradiation with concurrent chemotherapy in locally advanced none-small cell lung cancer patients.

Description:

This Phase II study is to determine the efficacy of split-course chemoradiotherapy(CCRT) in locally advanced non-small cell lung cancer.

Patients receive four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy/17 fractions and 15-18 Gy/5-6 fractions administered in the first and second courses, respectively, with about one-month break. The primary endpoint is progression-free survival, which is calculated from the start of RT to the first identification of disease progression or death. 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: 99
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• 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.

• 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
• Small Cell Lung Carcinoma

Intervention

Radiation:
• split-course radiotherapy
Patients are irradiation at a palliative dose in the initial course: 51Gy/17f to PTV-GTV. The disease is re-evaluated three weeks after the end of the initial course using CT. The patient without disease progression according to the RECIST criteria and had a recovery of lung function should get the additional boost. In the second course, the tumor is repositioned and scanned. The residual tumor is then treated with the second course of radiotherapy. A dose of 15-18 Gy/5-6f 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 (33)

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* Note: There are 33 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		3 years
Secondary	rate of grade 3-4 radiation esophagitis		1 year
Secondary	rate of grade 3-4 radiation pneumonitis		1 year