Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT02803151
Status:
UNKNOWN
Last Update Posted:
2019-03-11
First Post:
2016-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
A Prospective Phase II Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: