Phase
Condition
Sarcoma
Treatment
Hypofractionationed Radiation Therapy
Radiation Therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a histologically confirmed STS of the retroperitoneal spaceor infra-peritoneal spaces of pelvis
Participant must have radiologically measurable disease (RECIST 1.1), as confirmedby abdomino-pelvic CT or MRI
Participant must have primary, locally recurrent, or metastatic disease requiringtreatment of the retroperitoneal mass
Tumor must be suitable for radiotherapy and surgery based on pre-treatment CTscan/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 chronicinflammatory 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 perL, platelet count ≥80 × 10⁹ cells per L, and total bilirubin <2 times upper limit ofnormal)
Women of child-bearing potential must have a negative pregnancy test within 3 weeksprior to the first day of study treatment
Patients capable of childbearing/reproductive potential should use adequatecontraception
Ability to understand and the willingness to sign a written informed consentdocument
Exclusion
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 cellsarcoma, osteosarcoma, chondrosarcoma, aggressive fibromatosis, or sarcomatoid ormetastatic 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 thetreating 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 forteratogenic or abortifacient effects.
HIV-positive individuals on combination antiretroviral therapy are ineligiblebecause of the potential for increased sensitivity to RT
Study Design
Study Description
Connect with a study center
Brigham and Women's Hospital / Dana Farber Cancer Institute
Boston, Massachusetts 02446
United StatesSite Not Available
Brigham and Women's Hospital / Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02446
United StatesActive - Recruiting

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