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Recruiting NCT06812052

Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery

Phase I Interventional Retroperitoneal Sarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation Therapy, Hypofractionationed Radiation Therapy.
Who it may be relevant to
Registry conditions: Retroperitoneal Sarcoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma

Overview

To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

Detailed description

To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

Interventions

  • Radiation Radiation Therapy
    In this study, patients will receive a hypofractionated course of radiation therapy of 2.85 Gy x 15 fractions (42.75 Gy). If there are 2 or more patients with dose-limiting toxicities, the radiation course will be de-escalated to 2.7 Gy x 15 fractions (40.5 Gy).
  • Radiation Hypofractionationed Radiation Therapy
    This group is receiving hypofractionated radiation therapy (shorter course of RT)

Primary outcome measures

  • Side effects from radiation therapy [Time frame: From enrollment to 30-days after the completion of radiation treatment]

Eligibility criteria

Inclusion criteria

  • Participants must have a histologically confirmed STS of the retroperitoneal space or infra-peritoneal spaces of pelvis
  • Participant must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT or MRI
  • Participant must have primary, locally recurrent, or metastatic disease requiring treatment of the retroperitoneal mass
  • Tumor must be suitable for radiotherapy and surgery based on pre-treatment CT scan/MRI in multidisciplinary discussion with surgeon and radiation oncologist (anticipated macroscopically complete resection, R0/R1 resection)
  • Age: 18 years or older
  • ECOG performance status ≤2
  • Absence of history of bowel obstruction, mesenteric ischemia, or severe chronic inflammatory bowel disease.
  • Normal renal function (calculated creatinine clearance ≥50 mL/min)
  • Normal bone marrow and hepatic function (white blood cell count ≥2·5 × 10⁹ cells per L, platelet count ≥80 × 10⁹ cells per L, and total bilirubin <2 times upper limit of normal)
  • Women of child-bearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment
  • Patients capable of childbearing/reproductive potential should use adequate contraception
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

  • Sarcoma originating from bone structure, abdominal or gynecological viscera
  • Any of the following histological subtypes: gastrointestinal stromal tumor, rhabdomyosarcoma, primitive neuroectodermal tumor or other small round blue cell sarcoma, osteosarcoma, chondrosarcoma, aggressive fibromatosis, or sarcomatoid or metastatic carcinoma
  • Prior RT to the RPS
  • Prior abdominal or pelvic irradiation for other prior malignancy or other disease
  • Prior different invasive malignancy may be eligible per the discretion of the treating investigator and review by the Principal Investigator (PI)
  • Prior chemotherapy or immunotherapy within 6 weeks of start of RT
  • Pregnant women are excluded from this study because RT has the potential for teratogenic or abortifacient effects.
  • HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for increased sensitivity to RT

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brigham and Women's Hospital / Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT06812052 · 24-450

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗