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Hypofractionated Radiotherapy Followed by Hypo-boost for Local Advanced NSCLC

Primary Purpose

Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

split-course radiotherapy

concurrent chemotherapy

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer, hypofractionated radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hui Liu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

split-course radiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

overall survival

response rate

rate of grade 3-4 radiation esophagitis

rate of grade 3-4 radiation pneumonitis

Full Information

NCT ID

NCT03900117

First Posted

March 31, 2019

Last Updated

October 25, 2022

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03900117

Brief Title

Hypofractionated Radiotherapy Followed by Hypo-boost for Local Advanced NSCLC

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

June 20, 2022 (Actual)

Study Completion Date

June 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer, hypofractionated radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

split-course radiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

split-course radiotherapy

Intervention Description

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

Drug

Intervention Name(s)

concurrent chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

progression-free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

3 years

Title

response rate

Time Frame

2 months

Title

rate of grade 3-4 radiation esophagitis

Time Frame

1 year

Title

rate of grade 3-4 radiation pneumonitis

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Liu, Ph.D

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hui Liu

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

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Hypofractionated Radiotherapy Followed by Hypo-boost for Local Advanced NSCLC

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