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SBRT-based PArtial Tumor Irradiation of HYpoxic Segment

NCT04168320 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-11-02

No results posted yet for this study

Summary

This study uses an unconventional radiotherapy schedule developed at our institute, consisting of a short course high-dose partial irradiation targeting exclusively the hypoxic segment of a bulky tumors, which in our preliminary study has shown to be capable of inducing abscopal and bystander effects. This approach is delivered by using a stereotactic radiotherapy technique so as to spare nearby organs at risk including the peritumoral immune microenvironment from irradiation as much as possible. Our approach consists of a single or up to 3 radiotherapy doses of at least 10 Gy per fraction prescribed to the 70% isodose line encompassing the hypoxic target volume. Radiotherapy will be administered at the precise timing determined specifically for each patient based on the serially mapped homeostatic immune fluctuations by monitoring the blood levels of the cytokines and inflammatory markers over the 2 weeks prior to irradiation. This is done in order to synchronize the radiation treatment with the favorable, most active anti-tumor immune system phase, so as to stimulate and increase anti-tumor immune system activity.

This is a monocentric, prospective, two-arm, phase I proof of principle study in which the investigator will enroll subjects with oligometastatic and/or locally advanced (N+) cancers with at least one "bulky" lesion (maximum diameter of at least 6 cm or greater). Patients with life expectancy of at least 3 months, who are ineligible for systemic therapy or experience disease progression with systemic therapies will be included. Radiotherapy will be administered to arm 1 at an estimated "less favorable time-position in immune cycle", while the second arm will have it administered at the estimated "most favorable time-position in immune cycle".

The primary endpoint will be the response rate of the non-targeted effects both bystander (local, at the level of the partially treated bulky tumor) and abscopal (distant, at the non-treated metastatic sites), defined as a tumor regression of at least 30%. Secondary endpoints will be safety, survival and analysis of the best timing for the administration of radiotherapy.

Conditions

  • Abscopal Effect
  • Bystander Effect
  • Unresectable Malignant Solid Neoplasm
  • Bulky Tumors

Interventions

RADIATION

SBRT-PATHY (SBRT-based PArtial Tumor irradiation targeting HYpoxic segment)

Novel stereotactic high-dose partial irradiation of the hypoxic segment of bulky tumors.

Sponsors & Collaborators

  • Klinikum Klagenfurt am Wörthersee

    lead OTHER

Principal Investigators

  • Slavisa Tubin, M.D. · KABEG Klinikum Klagenfurt

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2022-02-14
Completion
2022-12-14

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04168320 on ClinicalTrials.gov