A Clinical Trial of Stereotactic Ablative Radiotherapy for Metastatic Lymphadenopathy

NCT02803151 | Unknown DMC

• 1 other identifier: 201601023RINA
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastasis of Malignant Neoplasm to Lymph Node

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

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

  From date of radiotherapy until 90 days after radiotherapy starts

• 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

• 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

• Overall survival

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

Other Outcomes (1)

• Changes of peripheral blood lymphocyte subpopulations

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

Study Arms (1)

Stereotactic ablative radiotherapy

EXPERIMENTAL

Image-guided stereotactic ablative radiotherapy

Radiation: Stereotactic ablative radiotherapy

Interventions

Stereotactic ablative radiotherapy RADIATION

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.

Also known as: Stereotactic body radiotherapy, Hypofractionated image-guided radiotherapy

Stereotactic ablative radiotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Tapei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphatic Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Feng-Ming Hsu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiao-Ling Tsai, MD

CONTACT

+886-2-23123456; chiaoling@ntuh.gov.tw

Feng-Ming Hsu, MD

CONTACT

+886-2-23123456

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 16, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2021
• Last Updated: March 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)