RECRUITING

Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma

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Conditions

Retroperitoneal Sarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-02
Study Completion:2028-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06327477

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have newly diagnosed, histologically or cytologically confirmed, untreated retroperitoneal soft tissue sarcoma
  2. * The soft-tissue sarcoma tumor must be at least 3 cm in diameter
  3. * Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
  4. * Patients must be age ≥ 18 years on day of signing any informed consent documents
  5. * 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
  6. * Leukocytes (white blood cells \[WBC\]) ≥ 3,000/mcL
  7. * Absolute neutrophil count (ANC) ≥ 1,500/mcL
  8. * Note: growth factor/transfusion is not permitted prior to these measurements being taken
  9. * Hemoglobin (Hgb) ≥ 9 g/d
  10. * Platelets (PLT) ≥ 100,000/mcL
  11. * Total bilirubin \< 1.5 x upper limit of normal (ULN) (or direct bilirubin \< ULN)
  12. * Aspartate Transferase (AST) ( serum glutamic-oxaloacetic transaminase \[SGOT\]) ≤ 2.5 x institutional ULN
  13. * Alanine transaminase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 2.5 x institutional ULN
  14. * Creatinine ≤ 1.5 x upper limit of normal (ULN)
  15. * Creatinine clearance ≥ 50mL/min
  16. * International normalized ratio (INR) (or prothrombin time \[PT\] or partial thromboplastin time \[PTT\]; one will be used) \< 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants \[within 10 days of treatment initiation\])
  17. * Activated partial thromboplastin time (aPTT) \< 1.5 X ULN (unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants \[within 10 days of treatment initiation\])
  18. * 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
  19. * 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.
  20. * 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.)
  21. * 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:
  22. * Has not undergone a hysterectomy or bilateral oophorectomy
  23. * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
  24. * 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
  25. * POCBP must be willing and able to use an adequate method of contraception
  26. * 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
  27. * Patients must have the ability to understand and the willingness to sign a written informed consent document
  28. * Patients must be medically fit to undergo surgery
  29. * Patients must have plans to undergo neoadjuvant radiation therapy and surgery with curative intent
  1. * Patients who have had one of the following soft tissue sarcoma subtypes where neoadjuvant chemotherapy is established as standard-of-care:
  2. * Extra-skeletal Ewing sarcoma
  3. * Embryonal rhabdomyosarcoma
  4. * Alveolar rhabdomyosarcoma
  5. * Desmoplastic small round cell tumor
  6. * Patients who have had any prior radiation therapy to the affected area
  7. * Patients who have had chemotherapy, radiotherapy, or other antineoplastic agents ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to planned treatment start date
  8. * 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
  9. * Patients who have taken steroid therapy or any other immunosuppressive therapy within 7 days of first dose prior to trial treatment
  10. * Patients with a known history of active tuberculosis (TB) (Bacillus tuberculosis)
  11. * 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
  12. * Patients with current or a history of any distant metastatic disease (including brain). Note: an isolated or oligo-metastatic regional occurrence may be allowed if all other criteria have been met and curative attempt is being pursued
  13. * Patients with a known history of (non-infectious) pneumonitis that required steroids or had evidence of current pneumonitis
  14. * Patients who have received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines, and as such, patients who have received these vaccines are not excluded; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed
  15. * Patients who have had an allogenic tissue/solid organ transplant
  16. * 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
  17. * Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
  18. * Hypertension that is not controlled on medication
  19. * Ongoing or active infection requiring systemic treatment
  20. * Symptomatic congestive heart failure
  21. * Unstable angina pectoris
  22. * Cardiac arrhythmia
  23. * Major surgery within 30 days of registration
  24. * 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
  25. * Patients with psychiatric illness/social situations that would limit compliance with study requirements
  26. * 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
  27. * 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
  28. * Patients who are currently participating in or have participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
  29. * Other study specific or disease criteria for exclusion (e.g., certain disease sub-types that are not eligible, patients who are unable to swallow oral medication if the study involves oral agents, etc.)

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
3126951301
cancer@northwestern.edu

Principal Investigator

Seth M Pollack, MD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Seth M Pollack, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-02
Study Completion Date2028-07-01

Study Record Updates

Study Start Date2024-04-02
Study Completion Date2028-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Retroperitoneal Sarcoma