Metastasis of Malignant Neoplasm to Lymph NodeNCT02803151
A Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy
A study testing Stereotactic ablative radiotherapy in people with Metastasis of Malignant Neoplasm to Lymph Node, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastasis of Malignant Neoplasm to Lymph Node
- What is being tested?
- Stereotactic ablative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2016to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Feng-Ming Hsu, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Tapei, 100
Feng-Ming Hsu, MD, 886-2-23123456 ext. 67061, hsufengming@ntuh.gov.tw
About this study
Official title: A Prospective Phase II Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy
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.
Read the 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
- Being tested
- Stereotactic ablative radiotherapy
- Keywords
- Stereotactic ablative radiotherapy, Lymph node metastasis, T cell immunity, cell-free DNA
- Medical subject headings
- Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic ablative radiotherapyRadiation
Also called Stereotactic body radiotherapy, Hypofractionated image-guided radiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic ablative radiotherapy | Experimental | Image-guided stereotactic ablative radiotherapy Receives: Radiation: Stereotactic ablative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
Patient reported outcome (Quality of Life questionnaire)
EORTC Quality of Life-Core 30 questionnaire module
Measured: at 1, 3 months after radiotherapy, and every 3 month thereafter until unequivocal progression, hospice care, or death, assessed up to 12 months
Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)
Common Toxicity Criteria for Adverse Events version 4
Measured: From date of radiotherapy until 90 days after radiotherapy starts
Late toxicity (Common Toxicity Criteria for Adverse Events version 4)
Common Toxicity Criteria for Adverse Events version 4
Measured: From 90 days after radiotherapy starts until the date of death from any cause, up to 60 months
Metastatic nodal progression
Number of participant with nodal progression on CT scan
Measured: 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
Overall survival
Number of participant alive
Measured: From date of enrollment until the date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastasis of Malignant Neoplasm to Lymph NodeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng-Ming Hsu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803151
- Sponsor's protocol ID
- 201601023RINA
- Status last verified
- Mar 2019
- First submitted
- 6 Jun 2016
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy
- ClinicalTrials.gov ID
- NCT02803151
- Acronym / sponsor ID
- 201601023RINA
- Keywords
- Stereotactic ablative radiotherapy, Lymph node metastasis, T cell immunity, cell-free DNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic ablative radiotherapy | Experimental | Radiation: Stereotactic ablative radiotherapyImage-guided stereotactic ablative radiotherapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%.
Key exclusion criteria (13 listed)
- 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:
- Will receive any other investigational agent or chemotherapy and/or target therapies during treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic ablative radiotherapyAlso: Stereotactic body radiotherapy, Hypofractionated image-guided radiotherapySABR 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. | Radiation | Stereotactic ablative radiotherapy |
Primary outcome
Local control (Response Evaluation Criteria In Solid Tumors version 1.1)
Time frame: 12 months
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
5 secondary outcomes
Patient reported outcome (Quality of Life questionnaire)
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
Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)
Time frame: From date of radiotherapy until 90 days after radiotherapy starts
Late toxicity (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
Metastatic nodal progression
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
Overall survival
Time frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng-Ming Hsu, MD contact
Feng-Ming Hsu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic ablative radiotherapy in people with Metastasis of Malignant Neoplasm to Lymph Node, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiao-Ling Tsai, MD (+886-2-23123456 ext. 62643, chiaoling@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (Response Evaluation Criteria In Solid Tumors version 1.1) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.