Retroperitoneal SarcomaPhase 1NCT06812052
Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery
A Phase 1 study testing Radiation Therapy and Hypofractionationed Radiation Therapy in people with Retroperitoneal Sarcoma, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retroperitoneal Sarcoma
- What is being tested?
- Radiation Therapy and Hypofractionationed Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2025to Nov 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital / Dana Farber Cancer Institute
Boston, Massachusetts, 02446
Miranda Lam, 617-732-7948, miranda_lam@dfci.harvard.edu
About this study
Official title: Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma
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)
Read the 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)
- Conditions
- Retroperitoneal Sarcoma
- Being tested
- Radiation Therapy, Hypofractionationed Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
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).
Hypofractionationed Radiation TherapyRadiation
This group is receiving hypofractionated radiation therapy (shorter course of RT)
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Radiation Therapy | Experimental | This group is receiving hypofractionated radiation therapy (shorter course of radiation therapy) Receives: Radiation: Radiation Therapy; Radiation: Hypofractionationed Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects from radiation therapy
Evaluation of acute radiation-related toxicity profile of each participant, specifically nausea, vomiting, diarrhea, and other gastrointestinal (GI) side effects.
Measured: From enrollment to 30-days after the completion of radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start29 May 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retroperitoneal SarcomaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miranda Lam, MD, Brigham and Women's Hospital
- Investigators
- Miranda Lam, Principal investigator, Dana-Farber/Brigham and Women's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812052
- Sponsor's protocol ID
- 24-450
- Status last verified
- May 2025
- First submitted
- 27 Jan 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes