Clinical trial NCT06812052: Short Course Radiation Treatment for Patients with Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery
Official title: Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Retroperitoneal Sarcoma
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)

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

Primary outcomes:
measure: Side effects from radiation therapy
timeFrame: From enrollment to 30-days after the completion of radiation treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital / Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber/Brigham and Women's Cancer Center
name: Miranda Lam
role: PRINCIPAL_INVESTIGATOR
References: