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

Mass General Brigham

Status and phase: Enrolling; Phase 1

Conditions: Retroperitoneal Sarcoma

Treatments: Radiation: Hypofractionationed Radiation Therapy; Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06812052

24-450

Details and patient eligibility

About

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)

Full 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)

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Hypofractionated Radiation Therapy

Experimental group

Description:

This group is receiving hypofractionated radiation therapy (shorter course of radiation therapy)

Treatment:

Radiation: Radiation Therapy

Radiation: Hypofractionationed Radiation Therapy