Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 and up

Proton therapy combined with standard radiation for treating retroperitoneal sarcoma

Official title: First-in-Human Phase I and II Study to Determine Safety and Efficacy of Proton-Spatially Fractionated Radiotherapy (P-SFRT) in Retroperitoneal Soft Tissue Sarcoma

Run by Northwestern University · NCT06327477 · Data updated 2026-11-12

This study is testing a new type of radiation therapy combined with standard treatment to see if it helps people with newly diagnosed retroperitoneal sarcoma before they have surgery.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment28 (estimated)
SponsorNorthwestern University
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Chicago, Illinois)
StatusRecruiting
StartedApril 2, 2024
Main results expectedJuly 1, 2028
Study endsJuly 1, 2029
Registry record updatedJuly 7, 2026
Trial IDNCT06327477 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with newly diagnosed, untreated retroperitoneal soft tissue sarcoma measuring at least 3 cm.

Probably not a fit

Patients with prior treatment for retroperitoneal sarcoma or those with significant comorbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects and optimal dosage of proton-spatially fractionated radiotherapy (P-SFRT) in combination with standard radiation therapy for patients with newly diagnosed retroperitoneal soft tissue sarcoma. The study aims to determine the maximum tolerated dose of P-SFRT and assess its efficacy prior to surgical intervention. Patients will receive P-SFRT followed by image-guided intensity-modulated radiation therapy (IG-IMRT) over several weeks, with subsequent surgical resection. The trial will also evaluate safety, progression-free survival, overall survival, and objective response rates.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with retroperitoneal sarcoma.

How similar studies have gone: Other studies have shown promise with spatially fractionated radiation therapy, but the combination with proton therapy is a novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients must have newly diagnosed, histologically or cytologically confirmed, untreated retroperitoneal soft tissue sarcoma Note: The soft-tissue sarcoma tumor must be at least 3 cm in diameter confirmed by imaging within 30 days of registration
* Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
* Patients must be age ≥ 18 years on day of signing any informed consent documents
* Patients must exhibit a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale or \>70% on the Karnofsky Scale
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) from time of informed consent and for the duration of study participation. Patients who can impregnate their partners must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) from time of informed consent and for the duration of study participation. Should a patient become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform their treating physician immediately.

  * Note: At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.)
  * Note: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    * Has not undergone a hysterectomy or bilateral oophorectomy
    * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
* POCBP must have a negative urine pregnancy test within 72 hours prior to undergoing CT simulation for P-SFRT. If a urine pregnancy test is positive or cannot be confirmed negative, a serum pregnancy test will be required
* POCBP must be willing and able to use an adequate method of contraception
* Patients with sperm-producing reproductive capacity (PWSPRC) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 120 days following completion of therapy. PWSPRC treated or enrolled on this protocol must also agree to refrain from donating sperm from time of informed consent for the duration of study participation and for 120 days following completion of therapy
* Patients must have the ability to understand and the willingness to sign a written informed consent document Note: Consent must be obtained within a 30 day period prior to patient registration +7 days.

Exclusion Criteria:

* Patients who have had one of the following soft tissue sarcoma subtypes where neoadjuvant chemotherapy is established as standard-of-care:

  * Extra-skeletal Ewing sarcoma
  * Embryonal rhabdomyosarcoma
  * Alveolar rhabdomyosarcoma
  * Desmoplastic small round cell tumor
* Patients who have had any prior radiation therapy to the affected area
* Patients who have had chemotherapy, radiotherapy, or other antineoplastic agents ≤ 14days prior to planned treatment start date
* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
* Patients who have taken steroid therapy or any other immunosuppressive therapy within 7 days of first dose prior to trial treatment
* Patients with a known history of active tuberculosis (TB) (Bacillus tuberculosis)
* Patients with a known history of active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
* Patients who have had an allogenic tissue/solid organ transplant
* Patients with a history of inflammatory bowel disorders (i.e., ulcerative colitis, Crohn's disease) or rheumatologic disorders (i.e., Sjogren's, scleroderma, rheumatoid arthritis) that serve as a contraindication to retroperitoneal radiation therapy
* Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:

  * Hypertension that is not controlled on medication
  * Ongoing or active infection requiring systemic treatment
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
  * Major surgery within 30 days of registration
  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient¡¦s safety or study endpoints
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Patients who are pregnant (positive urine pregnancy test within 72 hours prior to enrollment) or nursing. If a urine pregnancy test is positive or cannot be confirmed negative, a serum pregnancy test will be required
* Patients who are expecting to become pregnant or impregnate their partner within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
* Patients who are currently participating in or have participated in a study of an investigational agent or has used an investigational device within 14 days of prior to planned treatment start date

Where it's running

  • Northwestern University
    Chicago, Illinois, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.