Retroperitoneal SarcomaSA03NCT00901836
Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma
A study testing Preoperative proton therapy and Surgery in people with Retroperitoneal Sarcoma, run by University of Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Retroperitoneal Sarcoma
- What is being tested?
- Preoperative proton therapy and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: A Pilot Study Investigating Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma
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.
Read the detailed description
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.
- Conditions
- Retroperitoneal Sarcoma
- Being tested
- Preoperative proton therapy, Surgery
- Keywords
- Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative proton therapyRadiation
28 daily fractions of 1.8 cobalt gray equivalent(CGE)/fx for total of 50.4 CGE over 5.5 weeks.
SurgeryProcedure or surgery
Standard of care surgery will be performed 4-6 weeks after completion of radiation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Preoperative proton therapy |
| Surgery | Active comparator | Standard of care surgery will be performed 4-6 weeks after the completion of radiation. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma.
Measured: 4-6 weeks post treatment
Secondary outcomes (5)
To evaluate the acute and late toxicity of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma
Measured: 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.
Measured: 4-6 weeks post treatment
To determine the percent tumor necrosis and percent apoptosis compared to historic controls treated with photon therapy.
Measured: 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.
Measured: 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.
Measured: 4-6 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Study closed due to feasability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Retroperitoneal SarcomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel J Indelicato, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901836
- Sponsor's protocol ID
- UFPTI 0805-SA03
- Acronym
- SA03
- Status last verified
- Feb 2017
- First submitted
- 13 May 2009
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2363604Ferrario T, Karakousis CP. Retroperitoneal sarcomas: grade and survival. Arch Surg. 2003 Mar;138(3):248-51. doi: 10.1001/archsurg.138.3.248.
PubMed 12611567Heslin 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.
PubMed 9256126Lewis 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.
PubMed 9742918Kilkenny JW 3rd, Bland KI, Copeland EM 3rd. Retroperitoneal sarcoma: the University of Florida experience. J Am Coll Surg. 1996 Apr;182(4):329-39.
PubMed 8605556Lewis JJ, Brennan MF. The management of retroperitoneal soft tissue sarcoma. Adv Surg. 1999;33:329-44. No abstract available.
PubMed 10572575Harrison 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.
PubMed 3736052van 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.
PubMed 8299085Tepper 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.
PubMed 6436198Koshy 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.
PubMed 18521378Weber 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.
PubMed 17606333Zlotecki 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.
PubMed 15923806Tuma 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.
PubMed 16985244Pollack 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.
PubMed 9806516Suit 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.
PubMed 3995476
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma
- ClinicalTrials.gov ID
- NCT00901836
- Acronym / sponsor ID
- SA03 / UFPTI 0805-SA03
- Conditions
- Retroperitoneal Sarcoma
- Keywords
- Sarcoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to feasability
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Proton Therapy | Experimental | Radiation: Preoperative proton therapy28 daily fractions of 1.8 cobalt gray equivalent(CGE)/fx for total of 50.4 CGE over 5.5 weeks. |
| Surgery | Active comparator | Procedure: SurgeryStandard of care surgery will be performed 4-6 weeks after the completion of radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative proton therapy28 daily fractions of 1.8 cobalt gray equivalent(CGE)/fx for total of 50.4 CGE over 5.5 weeks. | Radiation | Preoperative Proton Therapy |
| SurgeryStandard of care surgery will be performed 4-6 weeks after completion of radiation. | Procedure or surgery | Surgery |
Primary outcome
To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma.
Time frame: 4-6 weeks post treatment
5 secondary outcomes
To evaluate the acute and late toxicity of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma
Time frame: 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.
Time frame: 4-6 weeks post treatment
To determine the percent tumor necrosis and percent apoptosis compared to historic controls treated with photon therapy.
Time frame: 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.
Time frame: 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.
Time frame: 4-6 weeks post treatment
Results and safety
The study was stopped early (reason given: Study closed due to feasability). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Background: PubMed 2363604Jaques 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.
- Background: PubMed 12611567Ferrario T, Karakousis CP. Retroperitoneal sarcomas: grade and survival. Arch Surg. 2003 Mar;138(3):248-51. doi: 10.1001/archsurg.138.3.248.
- Background: PubMed 9256126Heslin 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.
- Background: PubMed 9742918Lewis 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.
- Background: PubMed 8605556Kilkenny JW 3rd, Bland KI, Copeland EM 3rd. Retroperitoneal sarcoma: the University of Florida experience. J Am Coll Surg. 1996 Apr;182(4):329-39.
- Background: PubMed 10572575Lewis JJ, Brennan MF. The management of retroperitoneal soft tissue sarcoma. Adv Surg. 1999;33:329-44. No abstract available.
- Background: PubMed 3736052Harrison 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.
- Background: PubMed 8299085van 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.
- Background: PubMed 6436198Tepper 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.
- Background: PubMed 18521378Koshy 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.
- Background: PubMed 17606333Weber 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.
- Background: PubMed 15923806Zlotecki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Indelicato, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative proton therapy and Surgery in people with Retroperitoneal Sarcoma, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed due to feasability). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma. (time frame: 4-6 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00901836, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.