RECRUITING

Short Course Radiation Treatment for Patients with Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery

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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

To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

Official Title

Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma

Quick Facts

Study Start:2025-02

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06812052

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 Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Miranda Lam

CONTACT

617-732-7948

miranda_lam@dfci.harvard.edu

Principal Investigator

Miranda Lam

PRINCIPAL_INVESTIGATOR

Dana-Farber/Brigham and Women's Cancer Center

Study Locations (Sites)

Brigham and Women's Hospital / Dana Farber Cancer Institute

Boston, Massachusetts, 02446

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Miranda Lam, PRINCIPAL_INVESTIGATOR, Dana-Farber/Brigham and Women's Cancer Center

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 Date2025-02

Study Completion Date2026-11

Study Record Updates

Study Start Date2025-02

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

Retroperitoneal Sarcoma