Recruiting
Phase 1
Phase 2

P-SFRT & SFRT

Sponsor:

Northwestern University

Code:

NCT06327477

Conditions

Retroperitoneal Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy

Biospecimen Collection

Computed Tomography

Intensity-Modulated Radiation Therapy

Resection

Study Details

Brief summary:

This phase I/II trial studies the side effects and best dose of proton-spatially fractionated radiotherapy (P-SFRT) and to see how well it works with standard radiation therapy in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard spatially fractionated radiotherapy (SFRT) refers to how the radiation is delivered to the tumor. SFRT means that different parts of the tumor are receiving different doses of radiation (fractionation) through beams that allow areas of higher and lower (peaks and valleys) of doses of the radiation. This spatial fractionation allows an overall high-dose radiation to be given in the peaks and those areas of the tumor may release cells and substances that may help with killing tumor cells, reducing tumor symptoms and shrinking tumors. Proton therapy is a type of radiation therapy that can overcome some of the barriers of standard SFRT. Protons are tiny radioactive particles that can be controlled in a beam to travel up to the tumor and, compared to the particles used in standard radiotherapy, proton therapy can deliver higher doses to the tumor because smaller doses of radiation are delivered to tissues away from the tumor. This allows radiation therapy dose-escalated (continuously increasing the dose of radiation) treatment to tumors even though the tumor is near radiation sensitive organs like the colon. Giving P-SFRT with standard radiation therapy may work better in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma.

Conditions

Retroperitoneal Sarcoma

Study ID

NCT06327477

Start date

Apr 2, 2024

Status verified date

Jul, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (P-SFRT, IG-IMRT)

Patients undergo P-SFRT over 1 fraction and then undergo IG-IMRT over 25-28 fractions for 35 to 42 days. Patients undergo surgical resection 21 to 35 days after radiation therapy. Patients undergo blood sample collection during screening and on study. Patients also undergo biopsy during screening and CT on study and on follow up.

Interventions

Biopsy

Undergo biopsy

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo CT

Intensity-Modulated Radiation Therapy

Undergo IG-IMRT

Resection

Undergo surgical resection

Spatially-fractionated Radiation Therapy

Undergo P-SFRT

Primary outcome measure

  • Recommended phase II dose (Phase I) [ Time Frame: Up to the first 30 days of treatment ]
  • Pathological complete response (Phase II) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Study Coordinator

3126951301cancer@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Vinai Gondi

312-695-6180

Principal Investigator:

Vinai Gondi, MD

More Information

Sponsor

Northwestern University

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-07-07.