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

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

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, Split-course Chemoradiotherapy, Locoregional recurrence, Postoperative recurrence

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.
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

Sites / Locations

Hui LiuRecruiting

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)-IMRT. Patients are irradiation at a palliative dose at the initial course: 40-51Gy/10-17f 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 15-24 Gy/5-8f 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 patients who develop local recurrence or distant recurrence

rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0

Full Information

NCT ID

NCT03006575

First Posted

April 13, 2016

Last Updated

January 15, 2021

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03006575

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (Actual)

Primary Completion Date

June 2020 (Actual)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

5. Study Description

Brief 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

Detailed 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.

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, Split-course Chemoradiotherapy, Locoregional recurrence, Postoperative recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

57 (Anticipated)

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

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

Intervention Type

Drug

Intervention Name(s)

concurrent chemotherapy

Intervention Description

weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation

Primary Outcome Measure Information:

Title

progression-free survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall Survival

Time Frame

2 years

Title

Response Rate

Time Frame

2 years

Title

rate of patients who develop local recurrence or distant recurrence

Time Frame

2 year

Title

rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0

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. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bo Qiu, attending

Phone

+86-020-87343031

qiubo@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Liu, professor

Organizational Affiliation

Sun yat-sen universtiy cancer center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hui Liu

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui Liu, professor

Phone

+86-020-87343031

liuhui@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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