search
Back to results

Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Proton (prostate bed) to 70.2 CGE
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Proton to 66.6 CGE
Sponsored by
Proton Collaborative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Proton Radiation, Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
  • Maximum PSA value of 20 ng/ml.

Exclusion Criteria:

  • Evidence of distant metastasis (M1).
  • Prior systemic chemotherapy for any reason.
  • Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
  • History of hip replacement.
  • Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Sites / Locations

  • University of Florida Proton Therapy InstituteRecruiting
  • Northwestern Medicine Chicago Proton CenterRecruiting
  • Inova Schar Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Postop Non-High Risk

Postop High Risk

Salvage Non-High Risk

Salvage High Risk

Arm Description

Proton to 66.6 CGE

IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

Proton to 70.2 CGE

IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Outcomes

Primary Outcome Measures

The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.

Secondary Outcome Measures

Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters

Full Information

First Posted
August 28, 2009
Last Updated
April 1, 2023
Sponsor
Proton Collaborative Group
Collaborators
University of Florida Health
search

1. Study Identification

Unique Protocol Identification Number
NCT00969111
Brief Title
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
Official Title
Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2031 (Anticipated)
Study Completion Date
August 2050 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proton Collaborative Group
Collaborators
University of Florida Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Proton Radiation, Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postop Non-High Risk
Arm Type
Experimental
Arm Description
Proton to 66.6 CGE
Arm Title
Postop High Risk
Arm Type
Experimental
Arm Description
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Arm Title
Salvage Non-High Risk
Arm Type
Experimental
Arm Description
Proton to 70.2 CGE
Arm Title
Salvage High Risk
Arm Type
Experimental
Arm Description
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Intervention Type
Radiation
Intervention Name(s)
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Intervention Description
Postop High Risk
Intervention Type
Radiation
Intervention Name(s)
Proton (prostate bed) to 70.2 CGE
Intervention Description
Salvage Non-High Risk
Intervention Type
Radiation
Intervention Name(s)
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Intervention Description
Salvage High Risk
Intervention Type
Radiation
Intervention Name(s)
Proton to 66.6 CGE
Intervention Description
Post-Op Non High Risk
Primary Outcome Measure Information:
Title
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
Time Frame
6 months after the end of radiation therapy
Secondary Outcome Measure Information:
Title
Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters
Time Frame
After radiation: every 6 months for 3 years, then annually for 20 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy. Maximum PSA value of 20 ng/ml. Exclusion Criteria: Evidence of distant metastasis (M1). Prior systemic chemotherapy for any reason. Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment. Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed). History of hip replacement. Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years. Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Morocco
Phone
630-836-8670
Email
mmorocco@pcgresearch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randal H Henderson, MD
Organizational Affiliation
University of Florida Proton Therapy Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Intake Coordinator
Phone
877-686-6009
First Name & Middle Initial & Last Name & Degree
Randal H Henderson, MD
Facility Name
Northwestern Medicine Chicago Proton Center
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Don Smith, MS, CCRC
Phone
630-933-7820
Email
donald.smith3@nm.org
First Name & Middle Initial & Last Name & Degree
William Hartsell, MD
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangeetha Moturi
Phone
571-472-0343
Email
sangeetha.moturi@inova.org
First Name & Middle Initial & Last Name & Degree
Kevin Choe, MD

12. IPD Sharing Statement

Citations:
Citation
American Cancer Society. 2007. Ref Type: Electronic Citation
Results Reference
background
PubMed Identifier
17105795
Citation
Thompson IM Jr, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006 Nov 15;296(19):2329-35. doi: 10.1001/jama.296.19.2329.
Results Reference
background
PubMed Identifier
15638892
Citation
Bott SR, Freeman AA, Stenning S, Cohen J, Parkinson MC. Radical prostatectomy: pathology findings in 1001 cases compared with other major series and over time. BJU Int. 2005 Jan;95(1):34-9. doi: 10.1111/j.1464-410X.2005.05245.x.
Results Reference
background
PubMed Identifier
19167731
Citation
Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol. 2009 Mar;181(3):956-62. doi: 10.1016/j.juro.2008.11.032. Epub 2009 Jan 23.
Results Reference
background
PubMed Identifier
16099293
Citation
Bolla M, van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Marechal JM, Scalliet P, Haustermans K, Pierart M; European Organization for Research and Treatment of Cancer. Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet. 2005 Aug 13-19;366(9485):572-8. doi: 10.1016/S0140-6736(05)67101-2.
Results Reference
background
PubMed Identifier
16194712
Citation
Bianco FJ Jr, Scardino PT, Eastham JA. Radical prostatectomy: long-term cancer control and recovery of sexual and urinary function ("trifecta"). Urology. 2005 Nov;66(5 Suppl):83-94. doi: 10.1016/j.urology.2005.06.116.
Results Reference
background
PubMed Identifier
17513807
Citation
Stephenson AJ, Scardino PT, Kattan MW, Pisansky TM, Slawin KM, Klein EA, Anscher MS, Michalski JM, Sandler HM, Lin DW, Forman JD, Zelefsky MJ, Kestin LL, Roehrborn CG, Catton CN, DeWeese TL, Liauw SL, Valicenti RK, Kuban DA, Pollack A. Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol. 2007 May 20;25(15):2035-41. doi: 10.1200/JCO.2006.08.9607. Erratum In: J Clin Oncol. 2007 Sep 10;25(26):4153.
Results Reference
background
PubMed Identifier
15685244
Citation
Dearnaley DP, Hall E, Lawrence D, Huddart RA, Eeles R, Nutting CM, Gadd J, Warrington A, Bidmead M, Horwich A. Phase III pilot study of dose escalation using conformal radiotherapy in prostate cancer: PSA control and side effects. Br J Cancer. 2005 Feb 14;92(3):488-98. doi: 10.1038/sj.bjc.6602301.
Results Reference
background
PubMed Identifier
12128107
Citation
Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8.
Results Reference
background
PubMed Identifier
15718316
Citation
Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154.
Results Reference
background
PubMed Identifier
7721636
Citation
Shipley WU, Verhey LJ, Munzenrider JE, Suit HD, Urie MM, McManus PL, Young RH, Shipley JW, Zietman AL, Biggs PJ, et al. Advanced prostate cancer: the results of a randomized comparative trial of high dose irradiation boosting with conformal protons compared with conventional dose irradiation using photons alone. Int J Radiat Oncol Biol Phys. 1995 Apr 30;32(1):3-12. doi: 10.1016/0360-3016(95)00063-5.
Results Reference
background
PubMed Identifier
16160131
Citation
Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233. Erratum In: JAMA. 2008 Feb 27;299(8):899-900.
Results Reference
background
PubMed Identifier
17538167
Citation
Swanson GP, Hussey MA, Tangen CM, Chin J, Messing E, Canby-Hagino E, Forman JD, Thompson IM, Crawford ED; SWOG 8794. Predominant treatment failure in postprostatectomy patients is local: analysis of patterns of treatment failure in SWOG 8794. J Clin Oncol. 2007 Jun 1;25(16):2225-9. doi: 10.1200/JCO.2006.09.6495.
Results Reference
background
PubMed Identifier
18234451
Citation
King CR, Kapp DS. Radiotherapy after prostatectomy: is the evidence for dose escalation out there? Int J Radiat Oncol Biol Phys. 2008 Jun 1;71(2):346-50. doi: 10.1016/j.ijrobp.2007.10.008. Epub 2008 Jan 30.
Results Reference
background
PubMed Identifier
18207668
Citation
King CR, Spiotto MT. Improved outcomes with higher doses for salvage radiotherapy after prostatectomy. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):23-7. doi: 10.1016/j.ijrobp.2007.09.047. Epub 2008 Jan 22.
Results Reference
background
PubMed Identifier
17418972
Citation
Feng M, Hanlon AL, Pisansky TM, Kuban D, Catton CN, Michalski JM, Zelefsky MJ, Kupelian PA, Pollack A, Kestin LL, Valicenti RK, DeWeese TL, Sandler HM. Predictive factors for late genitourinary and gastrointestinal toxicity in patients with prostate cancer treated with adjuvant or salvage radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1417-23. doi: 10.1016/j.ijrobp.2007.01.049. Epub 2007 Apr 6.
Results Reference
background
PubMed Identifier
17904306
Citation
Vargas C, Fryer A, Mahajan C, Indelicato D, Horne D, Chellini A, McKenzie C, Lawlor P, Henderson R, Li Z, Lin L, Olivier K, Keole S. Dose-volume comparison of proton therapy and intensity-modulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):744-51. doi: 10.1016/j.ijrobp.2007.07.2335. Epub 2007 Sep 27.
Results Reference
background
PubMed Identifier
15145147
Citation
Slater JD, Rossi CJ Jr, Yonemoto LT, Bush DA, Jabola BR, Levy RP, Grove RI, Preston W, Slater JM. Proton therapy for prostate cancer: the initial Loma Linda University experience. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):348-52. doi: 10.1016/j.ijrobp.2003.10.011.
Results Reference
background
PubMed Identifier
11744442
Citation
Partin AW, Mangold LA, Lamm DM, Walsh PC, Epstein JI, Pearson JD. Contemporary update of prostate cancer staging nomograms (Partin Tables) for the new millennium. Urology. 2001 Dec;58(6):843-8. doi: 10.1016/s0090-4295(01)01441-8.
Results Reference
background
PubMed Identifier
17459606
Citation
Spiotto MT, Hancock SL, King CR. Radiotherapy after prostatectomy: improved biochemical relapse-free survival with whole pelvic compared with prostate bed only for high-risk patients. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):54-61. doi: 10.1016/j.ijrobp.2007.02.035. Epub 2007 Apr 24.
Results Reference
background
PubMed Identifier
12126818
Citation
Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.
Results Reference
background
PubMed Identifier
15337535
Citation
Crook J, Ludgate C, Malone S, Lim J, Perry G, Eapen L, Bowen J, Robertson S, Lockwood G. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):15-23. doi: 10.1016/j.ijrobp.2004.02.022.
Results Reference
background
PubMed Identifier
15315996
Citation
D'Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):821-7. doi: 10.1001/jama.292.7.821.
Results Reference
background
PubMed Identifier
14581419
Citation
Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. doi: 10.1200/JCO.2003.11.023. Erratum In: J Clin Oncol. 2004 Jan 15;22(2):386.
Results Reference
background
PubMed Identifier
11483335
Citation
Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. doi: 10.1016/s0360-3016(01)01579-6.
Results Reference
background
PubMed Identifier
15817329
Citation
Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. doi: 10.1016/j.ijrobp.2004.08.047.
Results Reference
background
PubMed Identifier
12743142
Citation
Roach M 3rd, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, Han S, Thomas CR Jr, Shipley WS; Radiation Therapy Oncology Group 9413. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003 May 15;21(10):1904-11. doi: 10.1200/JCO.2003.05.004.
Results Reference
background
PubMed Identifier
16257791
Citation
Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. doi: 10.1016/S1470-2045(05)70348-X.
Results Reference
background
PubMed Identifier
15890582
Citation
Ghilezan MJ, Jaffray DA, Siewerdsen JH, Van Herk M, Shetty A, Sharpe MB, Zafar Jafri S, Vicini FA, Matter RC, Brabbins DS, Martinez AA. Prostate gland motion assessed with cine-magnetic resonance imaging (cine-MRI). Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):406-17. doi: 10.1016/j.ijrobp.2003.10.017.
Results Reference
background
PubMed Identifier
10348281
Citation
Padhani AR, Khoo VS, Suckling J, Husband JE, Leach MO, Dearnaley DP. Evaluating the effect of rectal distension and rectal movement on prostate gland position using cine MRI. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):525-33. doi: 10.1016/s0360-3016(99)00040-1.
Results Reference
background
PubMed Identifier
11849792
Citation
Litzenberg D, Dawson LA, Sandler H, Sanda MG, McShan DL, Ten Haken RK, Lam KL, Brock KK, Balter JM. Daily prostate targeting using implanted radiopaque markers. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):699-703. doi: 10.1016/s0360-3016(01)02654-2.
Results Reference
background
PubMed Identifier
16545919
Citation
Litzenberg DW, Balter JM, Hadley SW, Sandler HM, Willoughby TR, Kupelian PA, Levine L. Influence of intrafraction motion on margins for prostate radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):548-53. doi: 10.1016/j.ijrobp.2005.12.033. Epub 2006 Mar 20.
Results Reference
background
PubMed Identifier
16111582
Citation
Vargas C, Yan D, Kestin LL, Krauss D, Lockman DM, Brabbins DS, Martinez AA. Phase II dose escalation study of image-guided adaptive radiotherapy for prostate cancer: use of dose-volume constraints to achieve rectal isotoxicity. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):141-9. doi: 10.1016/j.ijrobp.2004.12.017.
Results Reference
background
PubMed Identifier
16029785
Citation
Vargas C, Martinez A, Kestin LL, Yan D, Grills I, Brabbins DS, Lockman DM, Liang J, Gustafson GS, Chen PY, Vicini FA, Wong JW. Dose-volume analysis of predictors for chronic rectal toxicity after treatment of prostate cancer with adaptive image-guided radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1297-308. doi: 10.1016/j.ijrobp.2004.12.052.
Results Reference
background
PubMed Identifier
16198509
Citation
Taylor A, Rockall AG, Reznek RH, Powell ME. Mapping pelvic lymph nodes: guidelines for delineation in intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1604-12. doi: 10.1016/j.ijrobp.2005.05.062. Epub 2005 Sep 29.
Results Reference
background
PubMed Identifier
15690650
Citation
Ehrenpreis ED, Jani A, Levitsky J, Ahn J, Hong J. A prospective, randomized, double-blind, placebo-controlled trial of retinol palmitate (vitamin A) for symptomatic chronic radiation proctopathy. Dis Colon Rectum. 2005 Jan;48(1):1-8. doi: 10.1007/s10350-004-0821-7.
Results Reference
background
PubMed Identifier
11869662
Citation
Denton A, Forbes A, Andreyev J, Maher EJ. Non surgical interventions for late radiation proctitis in patients who have received radical radiotherapy to the pelvis. Cochrane Database Syst Rev. 2002;(1):CD003455. doi: 10.1002/14651858.CD003455.
Results Reference
background
PubMed Identifier
10962052
Citation
Cavcic J, Turcic J, Martinac P, Jelincic Z, Zupancic B, Panijan-Pezerovic R, Unusic J. Metronidazole in the treatment of chronic radiation proctitis: clinical trial. Croat Med J. 2000 Sep;41(3):314-8.
Results Reference
background
PubMed Identifier
17395040
Citation
Delanian S, Lefaix JL. Current management for late normal tissue injury: radiation-induced fibrosis and necrosis. Semin Radiat Oncol. 2007 Apr;17(2):99-107. doi: 10.1016/j.semradonc.2006.11.006.
Results Reference
background
PubMed Identifier
10098440
Citation
Lefaix JL, Delanian S, Vozenin MC, Leplat JJ, Tricaud Y, Martin M. Striking regression of subcutaneous fibrosis induced by high doses of gamma rays using a combination of pentoxifylline and alpha-tocopherol: an experimental study. Int J Radiat Oncol Biol Phys. 1999 Mar 1;43(4):839-47. doi: 10.1016/s0360-3016(98)00419-2.
Results Reference
background
PubMed Identifier
12829674
Citation
Delanian S, Porcher R, Balla-Mekias S, Lefaix JL. Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis. J Clin Oncol. 2003 Jul 1;21(13):2545-50. doi: 10.1200/JCO.2003.06.064.
Results Reference
background
PubMed Identifier
18374505
Citation
Spry N, Halkett G, Aoun S, Spry J, Yeoh E. Development of a European organization for research and treatment of cancer module to assess the quality of life of patients with proctitis after pelvic radiotherapy for malignancy. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):522-8. doi: 10.1016/j.ijrobp.2007.12.062. Epub 2008 Apr 18.
Results Reference
background

Learn more about this trial

Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

We'll reach out to this number within 24 hrs