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New treatment option for Retroperitoneal Sarcoma
Official title Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery
ClinicalTrials.gov ID: NCT06812052
What this study is testing
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Age: 18 years or older
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.