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A Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy

Primary Purpose

Metastasis of Malignant Neoplasm to Lymph Node

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Stereotactic ablative radiotherapy

About this trial

This is an interventional treatment trial for Metastasis of Malignant Neoplasm to Lymph Node focused on measuring Stereotactic ablative radiotherapy, Lymph node metastasis, T cell immunity, cell-free DNA

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

Patients with a histologic diagnosis of non-hematopoietic malignancy
Radiographic evidence of measurable enlarged metastatic lymph node(s) with short-axis ≥ 1 cm
Patients do not have prior radiotherapy to the index node(s)
Age ≥ 20 years
Karnofsky performance status (KPS) ≥ 60%.
Life expectancy of ≥ 4 month
Patients must have adequate renal function with serum creatinine ≤ 2.0 mg/dL measured within 90 days prior to registration
Women of childbearing potential and male participants must practice adequate contraception
Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent

Exclusion criteria

Prior radiotherapy to the index metastatic lymph node(s)
Sum of the greatest dimensions of index lymph note(s) exceed 6 cm
Inability to achieve the minimal required radiation dose (36Gy)
Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
1. Uncontrolled active infection requiring intravenous antibiotics at the time of registration
2. Transmural myocardial infarction ≤ 6 months prior to registration
3. Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration
4. Life-threatening uncontrolled clinically significant cardiac arrhythmias
5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
6. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
7. Uncontrolled psychiatric disorder
Will receive any other investigational agent or chemotherapy and/or target therapies during treatment
Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic ablative radiotherapy

Arm Description

Image-guided stereotactic ablative radiotherapy

Outcomes

Primary Outcome Measures

Local control (Response Evaluation Criteria In Solid Tumors version 1.1)

Number of participant with local progression of index metastatic lymph receiving stereotactic ablative radiotherapy, assessed on CT scan according to Response Evaluation Criteria In Solid Tumors version 1.1

Secondary Outcome Measures

Patient reported outcome (Quality of Life questionnaire)

EORTC Quality of Life-Core 30 questionnaire module

Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)

Common Toxicity Criteria for Adverse Events version 4

Late toxicity (Common Toxicity Criteria for Adverse Events version 4)

Common Toxicity Criteria for Adverse Events version 4

Metastatic nodal progression

Number of participant with nodal progression on CT scan

Overall survival

Number of participant alive

Full Information

NCT ID

NCT02803151

First Posted

June 6, 2016

Last Updated

March 7, 2019

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02803151

Brief Title

A Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy

Official Title

A Prospective Phase II Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Lymph node metastasis is one of the most common sites to develop disease recurrence or progression after initial local treatment for primary solid malignancies or systemic treatment for advanced metastases. No specific treatment modality has been established as the standard therapy. Systemic therapy is usually considered since lymphadenopathy is considered as a sign of disease dissemination though aggressive local treatment, including surgical lymphoadenectomy or radical radiotherapy might result in long-term survival in selected patients. The concept of stereotactic ablative radiotherapy (SABR), a high dose of radiation targeted to a pathological entity and delivered in a few fractions, has proven so successful at treating both benign and malignant lesions that it changed the paradigm for radiation therapy. The radiobiology of SABR has been shown to be very favorable for tumor control. Clinical experiences suggested that SABR might offer excellent in-field tumor control with low toxicity profile in selected patients, although the majority of reports are retrospective and include small patients series with heterogeneous tumor sites and dose-fractionation schedules. At present, there is lack of validated prognostic factors to identify the patients who might benefit most from ablative local therapy for metastatic lymph node(s). The mechanism of effect of SABR on the cancer lesions is not yet clear. Apart from its direct effect on clonogenic cancer cells, an immune-mediated process was also hypothesized. Therefore, the present study is aimed to provide a better understanding about utilization of SABR for metastatic lymph node(s). The associated translational researches will also advance our knowledge in the immune system reactions to SABR.

Detailed Description

This is a single institutional, single-arm, phase II trial to assess the local control rate of oligo-metastatic or oligo-progressive lymph node treated by stereotactic ablative radiotherapy at 1 year. Patients with pathologically proven non-hematopoietic malignancy patients with radiographic evidence of evaluable regional recurrent, oligo-metastatic or oligo-progressive lymph nodes are eligible for enrolment. Stereotactic Ablative Radiotherapy: The lymph node planning target volume (PTV) will receive the prescribed dose according to the assigned treatment group. The dose is prescribed such as 90-95% of PTV is covered by the prescription dose. If the critical structures exceed the defined dose limitation, a dose reduction method is applied as protocol defined. Dose inhomogeneity can exist within the clinical target volume (CTV). Treatment will be delivered in six fractions to the target volume and given once per day, 2-3 fractions per week with no more than 2 daily consecutive fractions, over 2 to 2.5 weeks. Target Radiation Dose: SABR with 45 Gy in six fractions to the defined target volume with met organ-at-risk constraint criteria using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Radiation Dose Reduction: Reduced Dose 10%: SABR with 40.05 Gy in six fractions to the defined target volume with met organ-at-risk constraint criteria Reduced Dose 20%: SABR with 36 Gy in six fractions to the defined target volume with met organ-at-risk constraint criteria

6. Conditions and Keywords

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

Metastasis of Malignant Neoplasm to Lymph Node

Keywords

Stereotactic ablative radiotherapy, Lymph node metastasis, T cell immunity, cell-free DNA

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stereotactic ablative radiotherapy

Arm Type

Experimental

Arm Description

Image-guided stereotactic ablative radiotherapy

Intervention Type

Radiation

Intervention Name(s)

Stereotactic ablative radiotherapy

Other Intervention Name(s)

Stereotactic body radiotherapy, Hypofractionated image-guided radiotherapy

Intervention Description

SABR with 36 to 45 Gy in six fractions to the defined target volume with met organ-at-risk constraint criteria using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Treatment should be given once per day, 2-3 fractions per week with no more than 2 consecutive daily fractions, over 2 to 2.5 weeks.

Primary Outcome Measure Information:

Title

Local control (Response Evaluation Criteria In Solid Tumors version 1.1)

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Patient reported outcome (Quality of Life questionnaire)

Description

EORTC Quality of Life-Core 30 questionnaire module

Time Frame

at 1, 3 months after radiotherapy, and every 3 month thereafter until unequivocal progression, hospice care, or death, assessed up to 12 months

Title

Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)

Description

Common Toxicity Criteria for Adverse Events version 4

Time Frame

From date of radiotherapy until 90 days after radiotherapy starts

Title

Late toxicity (Common Toxicity Criteria for Adverse Events version 4)

Description

Common Toxicity Criteria for Adverse Events version 4

Time Frame

From 90 days after radiotherapy starts until the date of death from any cause, up to 60 months

Title

Metastatic nodal progression

Description

Number of participant with nodal progression on CT scan

Time Frame

From date of enrolment until the date of first documented metastatic nodal progression or date of death from any cause, whichever came first, assessed up to 60 months

Title

Overall survival

Description

Number of participant alive

Time Frame

From date of enrollment until the date of death from any cause, assessed up to 60 months

Other Pre-specified Outcome Measures:

Title

Changes of peripheral blood lymphocyte subpopulations

Description

T-cell subpopulation (CD3/4/8/19/16+56)

Time Frame

at baseline, 2 weeks, 1, 2, 3, 6, and 12 months after radiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Patients with a histologic diagnosis of non-hematopoietic malignancy Radiographic evidence of measurable enlarged metastatic lymph node(s) with short-axis ≥ 1 cm Patients do not have prior radiotherapy to the index node(s) Age ≥ 20 years Karnofsky performance status (KPS) ≥ 60%. Life expectancy of ≥ 4 month Patients must have adequate renal function with serum creatinine ≤ 2.0 mg/dL measured within 90 days prior to registration Women of childbearing potential and male participants must practice adequate contraception Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent Exclusion criteria Prior radiotherapy to the index metastatic lymph node(s) Sum of the greatest dimensions of index lymph note(s) exceed 6 cm Inability to achieve the minimal required radiation dose (36Gy) Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows: Uncontrolled active infection requiring intravenous antibiotics at the time of registration Transmural myocardial infarction ≤ 6 months prior to registration Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration Life-threatening uncontrolled clinically significant cardiac arrhythmias Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration Uncontrolled psychiatric disorder Will receive any other investigational agent or chemotherapy and/or target therapies during treatment Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic

Central Contact Person:

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

Chiao-Ling Tsai, MD

Phone

+886-2-23123456

Ext

62643

chiaoling@ntuh.gov.tw

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

Feng-Ming Hsu, MD

Phone

+886-2-23123456

Ext

67061

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Feng-Ming Hsu, MD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Tapei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Feng-Ming Hsu, MD

Phone

886-2-23123456

Ext

67061

hsufengming@ntuh.gov.tw

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy

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