A Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy
- Conditions
- Metastasis of Malignant Neoplasm to Lymph Node
- Interventions
- Radiation: Stereotactic ablative radiotherapy
- Registration Number
- NCT02803151
- Lead Sponsor
- National Taiwan University Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 59
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stereotactic ablative radiotherapy Stereotactic ablative radiotherapy Image-guided stereotactic ablative radiotherapy
- Primary Outcome Measures
Name Time Method Local control (Response Evaluation Criteria In Solid Tumors version 1.1) 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
- Secondary Outcome Measures
Name Time Method Patient reported outcome (Quality of Life questionnaire) at 1, 3 months after radiotherapy, and every 3 month thereafter until unequivocal progression, hospice care, or death, assessed up to 12 months EORTC Quality of Life-Core 30 questionnaire module
Acute toxicity (Common Toxicity Criteria for Adverse Events version 4) From date of radiotherapy until 90 days after radiotherapy starts Common Toxicity Criteria for Adverse Events version 4
Late toxicity (Common Toxicity Criteria for Adverse Events version 4) From 90 days after radiotherapy starts until the date of death from any cause, up to 60 months Common Toxicity Criteria for Adverse Events version 4
Metastatic nodal progression 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 Number of participant with nodal progression on CT scan
Overall survival From date of enrollment until the date of death from any cause, assessed up to 60 months Number of participant alive
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Tapei, Taiwan