Not provided
Not provided
Not provided
Not provided
Study closed due to feasability
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Proton Therapy | Experimental | 28 daily fractions of 1.8 cobalt gray equivalent(CGE)/fx for total of 50.4 CGE over 5.5 weeks. |
|
| Surgery | Active Comparator | Standard of care surgery will be performed 4-6 weeks after the completion of radiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative proton therapy | Radiation | 28 daily fractions of 1.8 cobalt gray equivalent(CGE)/fx for total of 50.4 CGE over 5.5 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma. | 4-6 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the acute and late toxicity of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma | Weekly during treatment, then every 3 months for 1 year, then every 6 months for 4 years. | |
| To determine the incidence of margin negative resection in patients compared to historic controls treated with photon therapy. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel J Indelicato, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Proton Therapy Institute | Jacksonville | Florida | 32206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2363604 | Background | Jaques 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. | |
| 12611567 | Background | Ferrario T, Karakousis CP. Retroperitoneal sarcomas: grade and survival. Arch Surg. 2003 Mar;138(3):248-51. doi: 10.1001/archsurg.138.3.248. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Surgery | Procedure | Standard of care surgery will be performed 4-6 weeks after completion of radiation. |
|
| 4-6 weeks post treatment |
| To determine the percent tumor necrosis and percent apoptosis compared to historic controls treated with photon therapy. | 4-6 weeks post treatment |
| To assess the predictive value of CT and MRI in evaluating pathologic tumor response and margin negative resection following proton radiotherapy. | 4-6 weeks post treatment |
| To compare the dose distribution to tumor and surrounding normal structures using dose volume histograms (DVHs) generated from the proton plan used to treat the patient and a theoretical photon plan generated for comparison purposes. | 4-6 weeks post treatment |
| 9256126 | Background | Heslin 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. |
| 9742918 | Background | Lewis 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. |
| 8605556 | Background | Kilkenny JW 3rd, Bland KI, Copeland EM 3rd. Retroperitoneal sarcoma: the University of Florida experience. J Am Coll Surg. 1996 Apr;182(4):329-39. |
| 10572575 | Background | Lewis JJ, Brennan MF. The management of retroperitoneal soft tissue sarcoma. Adv Surg. 1999;33:329-44. No abstract available. |
| 3736052 | Background | Harrison 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. |
| 8299085 | Background | van 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. |
| 6436198 | Background | Tepper JE, Gunderson LL, Orlow E, Cohen AM, Hedberg SE, Shipley WU, Blitzer PH, Rich T. Complications of intraoperative radiation therapy. Int J Radiat Oncol Biol Phys. 1984 Oct;10(10):1831-9. doi: 10.1016/0360-3016(84)90258-x. |
| 18521378 | Background | Koshy M, Landry JC, Lawson JD, Staley CA, Esiashvili N, Howell R, Ghavidel S, Davis LW. Intensity modulated radiation therapy for retroperitoneal sarcoma: a case for dose escalation and organ at risk toxicity reduction. Sarcoma. 2003;7(3-4):137-48. doi: 10.1080/13577140310001644751. |
| 17606333 | Background | Weber DC, Rutz HP, Bolsi A, Pedroni E, Coray A, Jermann M, Lomax AJ, Hug EB, Goitein G. Spot scanning proton therapy in the curative treatment of adult patients with sarcoma: the Paul Scherrer institute experience. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):865-71. doi: 10.1016/j.ijrobp.2007.04.034. Epub 2007 Jul 2. |
| 15923806 | Background | Zlotecki RA, Katz TS, Morris CG, Lind DS, Hochwald SN. Adjuvant radiation therapy for resectable retroperitoneal soft tissue sarcoma: the University of Florida experience. Am J Clin Oncol. 2005 Jun;28(3):310-6. doi: 10.1097/01.coc.0000158441.96455.31. |
| 16985244 | Background | Tuma RS. Sometimes size doesn't matter: reevaluating RECIST and tumor response rate endpoints. J Natl Cancer Inst. 2006 Sep 20;98(18):1272-4. doi: 10.1093/jnci/djj403. No abstract available. |
| 9806516 | Background | Pollack A, Zagars GK, Goswitz MS, Pollock RA, Feig BW, Pisters PW. Preoperative vs. postoperative radiotherapy in the treatment of soft tissue sarcomas: a matter of presentation. Int J Radiat Oncol Biol Phys. 1998 Oct 1;42(3):563-72. doi: 10.1016/s0360-3016(98)00277-6. |
| 3995476 | Background | Suit HD, Mankin HJ, Wood WC, Proppe KH. Preoperative, intraoperative, and postoperative radiation in the treatment of primary soft tissue sarcoma. Cancer. 1985 Jun 1;55(11):2659-67. doi: 10.1002/1097-0142(19850601)55:113.0.co;2-q. |
| 12103287 | Background | O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41. doi: 10.1016/S0140-6736(02)09292-9. |
| 15948265 | Background | Davis AM, O'Sullivan B, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Hammond A, Benk V, Kandel R, Goddard K, Freeman C, Sadura A, Zee B, Day A, Tu D, Pater J; Canadian Sarcoma Group; NCI Canada Clinical Trial Group Randomized Trial. Late radiation morbidity following randomization to preoperative versus postoperative radiotherapy in extremity soft tissue sarcoma. Radiother Oncol. 2005 Apr;75(1):48-53. doi: 10.1016/j.radonc.2004.12.020. |
| 12796356 | Background | Borden EC, Baker LH, Bell RS, Bramwell V, Demetri GD, Eisenberg BL, Fletcher CD, Fletcher JA, Ladanyi M, Meltzer P, O'Sullivan B, Parkinson DR, Pisters PW, Saxman S, Singer S, Sundaram M, van Oosterom AT, Verweij J, Waalen J, Weiss SW, Brennan MF. Soft tissue sarcomas of adults: state of the translational science. Clin Cancer Res. 2003 Jun;9(6):1941-56. |
| 11777636 | Background | Baglan KL, Frazier RC, Yan D, Huang RR, Martinez AA, Robertson JM. The dose-volume relationship of acute small bowel toxicity from concurrent 5-FU-based chemotherapy and radiation therapy for rectal cancer. Int J Radiat Oncol Biol Phys. 2002 Jan 1;52(1):176-83. doi: 10.1016/s0360-3016(01)01820-x. |
| 17904305 | Background | Robertson JM, Lockman D, Yan D, Wallace M. The dose-volume relationship of small bowel irradiation and acute grade 3 diarrhea during chemoradiotherapy for rectal cancer. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):413-8. doi: 10.1016/j.ijrobp.2007.06.066. Epub 2007 Sep 27. |
| 7577052 | Background | Letschert JG. The prevention of radiation-induced small bowel complications. Eur J Cancer. 1995 Jul-Aug;31A(7-8):1361-5. doi: 10.1016/0959-8049(95)00179-m. |
| 8457152 | Background | Sindelar WF, Kinsella TJ, Chen PW, DeLaney TF, Tepper JE, Rosenberg SA, Glatstein E. Intraoperative radiotherapy in retroperitoneal sarcomas. Final results of a prospective, randomized, clinical trial. Arch Surg. 1993 Apr;128(4):402-10. doi: 10.1001/archsurg.1993.01420160040005. |