Is NCT06327477 recruiting in Chicago, IL?

Yes, NCT06327477 is currently recruiting participants at its Chicago, IL location. This retroperitoneal sarcoma clinical trial is actively enrolling qualified participants.

How do I join the retroperitoneal sarcoma clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Retroperitoneal Sarcoma Clinical Trial in Chicago, IL

About This Retroperitoneal Sarcoma Study in Chicago

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.

Sponsor: Northwestern University

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT06327477) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Retroperitoneal Sarcoma Treatment Options in Chicago, IL

If you're searching for retroperitoneal sarcoma treatment options in Chicago, IL, this clinical trial (NCT06327477) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced retroperitoneal sarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all retroperitoneal sarcoma clinical trials near you to find additional studies recruiting in your area.

Retroperitoneal Sarcoma Clinical Trial in Chicago, IL

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