Study of Split-course Chemoradiotherapy For Postoperative Locoregional Recurrence Of Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Prospective, Randomized, Phase Ⅱ Study of Split-course Chemoradiotherapy For Locoregional Recurrence Of Non-small Cell Lung Cancer After Surgical Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03006575
• Other study ID #: GASTO-1017
• Status: Recruiting
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: July 2021

Study information

• Verified date: January 2021
• Source: Sun Yat-sen University
• Contact: Bo Qiu, attending
• Phone: +86-020-87343031
• Email: qiubo[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase II randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection

Description:

This Phase II randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection. Patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with split-course thoracic radiotherapy of 40-51 Gy/10-17 fractions and 15-24 Gy/5-8 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: Recruiting
• Enrollment: 57
• Est. completion date: July 2021
• Est. primary completion date: June 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.
• Postoperative locoregional recurrence including ipsilateral hemithorax and the mediastinum.
• 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
• Forced expiratory volume at one second (FEV1) >0.8 L
• Coagulation tests 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
• Second primary carcinoma of the lung
• Contraindication for chemotherapy
• Malignant pleural or pericardial effusion.
• Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dos
• 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
• Recurrence

Intervention

Radiation:
• split-course radiotherapy
split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f

Drug:
• concurrent chemotherapy
weekly docetaxel(25mg/?) and nedaplatin(25mg/?) concurrent with chest radiation

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, 

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		2 years
Secondary	Overall Survival		2 years
Secondary	Response Rate		2 years
Secondary	rate of patients who develop local recurrence or distant recurrence		2 year
Secondary	rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0		1 year