Metastasis of Malignant Neoplasm to Lymph Node Clinical Trial
Official title:
A Prospective Phase II Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy
| NCT number | NCT02803151 |
| Other study ID # | 201601023RINA |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2016 |
| Est. completion date | May 2021 |
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.
| Status | Recruiting |
| Enrollment | 59 |
| Est. completion date | May 2021 |
| Est. primary completion date | May 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion criteria 1. Patients with a histologic diagnosis of non-hematopoietic malignancy 2. Radiographic evidence of measurable enlarged metastatic lymph node(s) with short-axis = 1 cm 3. Patients do not have prior radiotherapy to the index node(s) 4. Age = 20 years 5. Karnofsky performance status (KPS) = 60%. 6. Life expectancy of = 4 month 7. Patients must have adequate renal function with serum creatinine = 2.0 mg/dL measured within 90 days prior to registration 8. Women of childbearing potential and male participants must practice adequate contraception 9. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent Exclusion criteria 1. Prior radiotherapy to the index metastatic lymph node(s) 2. Sum of the greatest dimensions of index lymph note(s) exceed 6 cm 3. Inability to achieve the minimal required radiation dose (36Gy) 4. 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 5. Will receive any other investigational agent or chemotherapy and/or target therapies during treatment 6. 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 |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Taiwan University Hospital | Tapei |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Changes of peripheral blood lymphocyte subpopulations | T-cell subpopulation (CD3/4/8/19/16+56) | at baseline, 2 weeks, 1, 2, 3, 6, and 12 months after radiotherapy | |
| Primary | 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 | 12 months | |
| Secondary | Patient reported outcome (Quality of Life questionnaire) | EORTC Quality of Life-Core 30 questionnaire module | at 1, 3 months after radiotherapy, and every 3 month thereafter until unequivocal progression, hospice care, or death, assessed up to 12 months | |
| Secondary | Acute toxicity (Common Toxicity Criteria for Adverse Events version 4) | Common Toxicity Criteria for Adverse Events version 4 | From date of radiotherapy until 90 days after radiotherapy starts | |
| Secondary | Late toxicity (Common Toxicity Criteria for Adverse Events version 4) | 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 | |
| Secondary | Metastatic nodal progression | Number of participant with nodal progression on CT scan | 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 | |
| Secondary | Overall survival | Number of participant alive | From date of enrollment until the date of death from any cause, assessed up to 60 months |