Clinical trial · Interventional
Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma
A Pilot Study Investigating Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma
NCT00901836CI-TRIAL-00025914SA03terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed due to feasability
Summary
Brief summary (as posted)
The goal of this study is to evaluate radiation treatment intended to increase the chance of curing your sarcoma and decrease the side effects of proton therapy. This study will also look at the tumor tissue that was removed during your initial biopsy and your final surgery for information that may help to treat retroperitoneal sarcoma in the future.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Retroperitoneal Sarcoma | Retroperitoneal Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative proton therapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preoperative Proton Therapy
- description
- 28 daily fractions of 1.8 cobalt gray equivalent(CGE)/fx for total of 50.4 CGE over 5.5 weeks.
- interventionNames
- Radiation: Preoperative proton therapy
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- Standard of care surgery will be performed 4-6 weeks after the completion of radiation.
- interventionNames
- Procedure: Surgery
Primary outcomes (1)
- measure
- To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically-confirmed intermediate or high grade retroperitoneal sarcomas of any histologic subtype. * Primary or recurrent disease isolated to a single intra-abdominal or retroperitoneal region is allowed. * Tumor must be considered potentially completely resectable as defined by cross sectional imaging (no 360o encasement of the superior mesenteric artery, aorta, inferior vena cava, iliac arteries or iliac veins and no extension of tumor into the vertebral column). * At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Patients must have ≤ grade 1 acute toxicities of any prior treatment with anti-cancer modalities (returned to baseline status as noted before most recent treatment). Patients with persisting, stable chronic toxicities from prior treatment ≤ grade 1 are eligible. * Age ≥18 years at time of consent. * Life expectancy of greater than 3 months. Physician documented. * Women of child-producing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and the subsequent 6 months. Patients must have a negative serum pregnancy test within 2 weeks prior to beginning treatment on this trial. Sexually active men must also use appropriate contraception method and should not father a child while receiving therapy during this study. * Ability to understand and the willingness to sign a written Institutional Review Board(IRB) stamped study specific informed consent document before undergoing research related procedures or study treatment. * Biopsy is required with pathologic confirmation of intermediate or high grade sarcoma with pathology review at the University of Florida. * Agree to allow their tissue to be used for current study. Exclusion Criteria: * Receiving any investigational agents. * Evidence of metastatic disease. * Uncontrolled intercurrent illness and/or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and nursing women are excluded from this study because the radiotherapy may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated. * All herbal and/or alternative medications should be discontinued while on study, including, but not limited to: Hydrastis canadensis (goldenseal), Uncaria tomentosa (cat's claw) or Echinacea angustifolia. * Requirement for treatment with immunosuppressive agents or chronic steroids. * Previous intra-abdominal or retroperitoneal radiotherapy. * Treatment with cytotoxic agents and/or treatment with biologic agents within the 4 weeks prior to beginning treatment on this study.
References
Publications (22)
- BACKGROUNDJaques DP, Coit DG, Hajdu SI, Brennan MF. Management of primary and recurrent soft-tissue sarcoma of the retroperitoneum. Ann Surg. 1990 Jul;212(1):51-9. doi: 10.1097/00000658-199007000-00008. PMID 2363604
- BACKGROUNDFerrario T, Karakousis CP. Retroperitoneal sarcomas: grade and survival. Arch Surg. 2003 Mar;138(3):248-51. doi: 10.1001/archsurg.138.3.248. PMID 12611567
- BACKGROUNDHeslin MJ, Lewis JJ, Nadler E, Newman E, Woodruff JM, Casper ES, Leung D, Brennan MF. Prognostic factors associated with long-term survival for retroperitoneal sarcoma: implications for management. J Clin Oncol. 1997 Aug;15(8):2832-9. doi: 10.1200/JCO.1997.15.8.2832. PMID 9256126
- BACKGROUNDLewis JJ, Leung D, Woodruff JM, Brennan MF. Retroperitoneal soft-tissue sarcoma: analysis of 500 patients treated and followed at a single institution. Ann Surg. 1998 Sep;228(3):355-65. doi: 10.1097/00000658-199809000-00008. PMID 9742918
- BACKGROUNDKilkenny JW 3rd, Bland KI, Copeland EM 3rd. Retroperitoneal sarcoma: the University of Florida experience. J Am Coll Surg. 1996 Apr;182(4):329-39. PMID 8605556
- BACKGROUNDLewis JJ, Brennan MF. The management of retroperitoneal soft tissue sarcoma. Adv Surg. 1999;33:329-44. No abstract available. PMID 10572575
- BACKGROUNDHarrison LB, Gutierrez E, Fischer JJ. Retroperitoneal sarcomas: the Yale experience and a review of the literature. J Surg Oncol. 1986 Jul;32(3):159-64. doi: 10.1002/jso.2930320309. PMID 3736052
- BACKGROUNDvan Doorn RC, Gallee MP, Hart AA, Gortzak E, Rutgers EJ, van Coevorden F, Keus RB, Zoetmulder FA. Resectable retroperitoneal soft tissue sarcomas. The effect of extent of resection and postoperative radiation therapy on local tumor control. Cancer. 1994 Feb 1;73(3):637-42. doi: 10.1002/1097-0142(19940201)73:33.0.co;2-y.