Short course radiation treatment for retroperitoneal sarcoma before surgery
Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma
This study is testing a shorter radiation treatment for patients with retroperitoneal sarcoma to see if it can be safely used before surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06812052 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety of moderately hypofractionated radiation therapy in patients with primary or locally recurrent retroperitoneal sarcoma. Participants will undergo radiation treatment, and the study will assess the acute radiation-related toxicity experienced within 30 days. The goal is to determine if this approach can be safely integrated into the treatment plan prior to surgical intervention. The study will involve careful monitoring of participants' health and response to the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed retroperitoneal sarcoma that is measurable and suitable for both radiation therapy and surgery.
Not a fit: Patients with a history of bowel obstruction, severe chronic inflammatory bowel disease, or those with significant renal or hepatic dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and reduce complications for patients with retroperitoneal sarcoma.
How similar studies have performed: Other studies have shown promise with hypofractionated radiation therapy in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital / Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Miranda Lam — Dana-Farber/Brigham and Women's Cancer Center
- Study coordinator: Miranda Lam
- Email: miranda_lam@dfci.harvard.edu
- Phone: 617-732-7948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.