Proton Radiation for Resectable Carcinoma of the Pancreas (PC02)
1 september 2017 uppdaterad av: University of Florida
A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas
The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer.
This study will look at the side effects from the treatment and the quality of your life in relation to pain.
It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Chemotherapy capecitabine on radiation days
Proton radiation over 6 weeks
Surgery 6 weeks after radiation completion
Adjuvant Chemotherapy starting 2-8 weeks after surgery with Gemzar
Studietyp
Interventionell
Inskrivning (Faktisk)
8
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Florida
-
Jacksonville, Florida, Förenta staterna, 32206
- University of Florida Proton Therapy Institute
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the pancreas.
- Patients must have marginally resectable disease.
- Patients with biliary obstruction must have adequate drainage prior to starting chemoradiation.
Exclusion Criteria:
- Evidence of distant metastasis including peritoneal seeding and/or ascites.
- Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
- Prior surgical resection.
- Gastroduodenal obstruction
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Proton radiation and chemotherapy
Proton radiation Capecitabine chemotherapy on radiation days Surgery Gemcitabine chemotherapy |
Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only Proton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks Surgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation Adjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar®) 1,000 mg/m2 IV total of 18 doses
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)
Tidsram: 1 year following the completion of radiation therapy
|
1 year following the completion of radiation therapy
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Collect and analyze tumor control outcomes
Tidsram: 1 year following the completion of radiation therapy
|
1 year following the completion of radiation therapy
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Romaine C Nichols, MD, University of Florida Proton Therapy Institute
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Buchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18;350(12):1200-10. doi: 10.1056/NEJMoa032295. Erratum In: N Engl J Med. 2004 Aug 12;351(7):726.
- Saif MW. Pancreatic cancer: highlights from the 42nd annual meeting of the American Society of Clinical Oncology, 2006. JOP. 2006 Jul 10;7(4):337-48.
- Ben-Josef E, Shields AF, Vaishampayan U, Vaitkevicius V, El-Rayes BF, McDermott P, Burmeister J, Bossenberger T, Philip PA. Intensity-modulated radiotherapy (IMRT) and concurrent capecitabine for pancreatic cancer. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):454-9. doi: 10.1016/j.ijrobp.2003.11.019.
- Hsiung-Stripp DC, McDonough J, Masters HM, Levin WP, Hahn SM, Jones HA, Metz JM. Comparative treatment planning between proton and X-ray therapy in pancreatic cancer. Med Dosim. 2001 Fall;26(3):255-9. doi: 10.1016/s0958-3947(01)00072-3.
- Mackean M, Planting A, Twelves C, Schellens J, Allman D, Osterwalder B, Reigner B, Griffin T, Kaye S, Verweij J. Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol. 1998 Sep;16(9):2977-85. doi: 10.1200/JCO.1998.16.9.2977.
- Hoff PM, Ansari R, Batist G, Cox J, Kocha W, Kuperminc M, Maroun J, Walde D, Weaver C, Harrison E, Burger HU, Osterwalder B, Wong AO, Wong R. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol. 2001 Apr 15;19(8):2282-92. doi: 10.1200/JCO.2001.19.8.2282.
- Dunst J, Reese T, Sutter T, Zuhlke H, Hinke A, Kolling-Schlebusch K, Frings S. Phase I trial evaluating the concurrent combination of radiotherapy and capecitabine in rectal cancer. J Clin Oncol. 2002 Oct 1;20(19):3983-91. doi: 10.1200/JCO.2002.02.049.
- Bussels B, Goethals L, Feron M, Bielen D, Dymarkowski S, Suetens P, Haustermans K. Respiration-induced movement of the upper abdominal organs: a pitfall for the three-dimensional conformal radiation treatment of pancreatic cancer. Radiother Oncol. 2003 Jul;68(1):69-74. doi: 10.1016/s0167-8140(03)00133-6.
- Eccles C, Brock KK, Bissonnette JP, Hawkins M, Dawson LA. Reproducibility of liver position using active breathing coordinator for liver cancer radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):751-9. doi: 10.1016/j.ijrobp.2005.05.066.
- Korreman SS, Pedersen AN, Nottrup TJ, Specht L, Nystrom H. Breathing adapted radiotherapy for breast cancer: comparison of free breathing gating with the breath-hold technique. Radiother Oncol. 2005 Sep;76(3):311-8. doi: 10.1016/j.radonc.2005.07.009.
- Sugahara S, Tokuuye K, Okumura T, Nakahara A, Saida Y, Kagei K, Ohara K, Hata M, Igaki H, Akine Y. Clinical results of proton beam therapy for cancer of the esophagus. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):76-84. doi: 10.1016/j.ijrobp.2004.04.003.
- Gierga DP, Chen GT, Kung JH, Betke M, Lombardi J, Willett CG. Quantification of respiration-induced abdominal tumor motion and its impact on IMRT dose distributions. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1584-95. doi: 10.1016/j.ijrobp.2003.09.077.
- Wong JW, Sharpe MB, Jaffray DA, Kini VR, Robertson JM, Stromberg JS, Martinez AA. The use of active breathing control (ABC) to reduce margin for breathing motion. Int J Radiat Oncol Biol Phys. 1999 Jul 1;44(4):911-9. doi: 10.1016/s0360-3016(99)00056-5.
- Singh AK, Tierney RM, Low DA, Parikh PJ, Myerson RJ, Deasy JO, Wu CS, Pereira GC, Wahab SH, Mutic S, Grigsby PW, Hope AJ. A prospective study of differences in duodenum compared to remaining small bowel motion between radiation treatments: implications for radiation dose escalation in carcinoma of the pancreas. Radiat Oncol. 2006 Sep 4;1:33. doi: 10.1186/1748-717X-1-33.
- Blackall JM, Ahmad S, Miquel ME, McClelland JR, Landau DB, Hawkes DJ. MRI-based measurements of respiratory motion variability and assessment of imaging strategies for radiotherapy planning. Phys Med Biol. 2006 Sep 7;51(17):4147-69. doi: 10.1088/0031-9155/51/17/003. Epub 2006 Aug 8.
- Fishman B, Pasternak S, Wallenstein SL, Houde RW, Holland JC, Foley KM. The Memorial Pain Assessment Card. A valid instrument for the evaluation of cancer pain. Cancer. 1987 Sep 1;60(5):1151-8. doi: 10.1002/1097-0142(19870901)60:53.0.co;2-g.
- Varadhachary GR, Tamm EP, Abbruzzese JL, Xiong HQ, Crane CH, Wang H, Lee JE, Pisters PW, Evans DB, Wolff RA. Borderline resectable pancreatic cancer: definitions, management, and role of preoperative therapy. Ann Surg Oncol. 2006 Aug;13(8):1035-46. doi: 10.1245/ASO.2006.08.011. Epub 2006 Jul 24.
- Spitz FR, Abbruzzese JL, Lee JE, Pisters PW, Lowy AM, Fenoglio CJ, Cleary KR, Janjan NA, Goswitz MS, Rich TA, Evans DB. Preoperative and postoperative chemoradiation strategies in patients treated with pancreaticoduodenectomy for adenocarcinoma of the pancreas. J Clin Oncol. 1997 Mar;15(3):928-37. doi: 10.1200/JCO.1997.15.3.928.
- Sohn TA, Yeo CJ, Cameron JL, Koniaris L, Kaushal S, Abrams RA, Sauter PK, Coleman J, Hruban RH, Lillemoe KD. Resected adenocarcinoma of the pancreas-616 patients: results, outcomes, and prognostic indicators. J Gastrointest Surg. 2000 Nov-Dec;4(6):567-79. doi: 10.1016/s1091-255x(00)80105-5.
- Bramhall SR, Allum WH, Jones AG, Allwood A, Cummins C, Neoptolemos JP. Treatment and survival in 13,560 patients with pancreatic cancer, and incidence of the disease, in the West Midlands: an epidemiological study. Br J Surg. 1995 Jan;82(1):111-5. doi: 10.1002/bjs.1800820137.
- Klinkenbijl JH, Jeekel J, Sahmoud T, van Pel R, Couvreur ML, Veenhof CH, Arnaud JP, Gonzalez DG, de Wit LT, Hennipman A, Wils J. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg. 1999 Dec;230(6):776-82; discussion 782-4. doi: 10.1097/00000658-199912000-00006.
- Further evidence of effective adjuvant combined radiation and chemotherapy following curative resection of pancreatic cancer. Gastrointestinal Tumor Study Group. Cancer. 1987 Jun 15;59(12):2006-10. doi: 10.1002/1097-0142(19870615)59:123.0.co;2-b.
- Neoptolemos JP, Stocken DD, Dunn JA, Almond J, Beger HG, Pederzoli P, Bassi C, Dervenis C, Fernandez-Cruz L, Lacaine F, Buckels J, Deakin M, Adab FA, Sutton R, Imrie C, Ihse I, Tihanyi T, Olah A, Pedrazzoli S, Spooner D, Kerr DJ, Friess H, Buchler MW; European Study Group for Pancreatic Cancer. Influence of resection margins on survival for patients with pancreatic cancer treated by adjuvant chemoradiation and/or chemotherapy in the ESPAC-1 randomized controlled trial. Ann Surg. 2001 Dec;234(6):758-68. doi: 10.1097/00000658-200112000-00007.
- Brunner TB, Grabenbauer GG, Meyer T, Golcher H, Sauer R, Hohenberger W. Primary resection versus neoadjuvant chemoradiation followed by resection for locally resectable or potentially resectable pancreatic carcinoma without distant metastasis. A multi-centre prospectively randomised phase II-study of the Interdisciplinary Working Group Gastrointestinal Tumours (AIO, ARO, and CAO). BMC Cancer. 2007 Mar 6;7:41. doi: 10.1186/1471-2407-7-41.
- Yoshida T, Matsumoto T, Sasaki A, Shibata K, Aramaki M, Kitano S. Outcome of paraaortic node-positive pancreatic head and bile duct adenocarcinoma. Am J Surg. 2004 Jun;187(6):736-40. doi: 10.1016/j.amjsurg.2003.07.031.
- Sasson AR, Wetherington RW, Hoffman JP, Ross EA, Cooper H, Meropol NJ, Freedman G, Pingpank JF, Eisenberg BL. Neoadjuvant chemoradiotherapy for adenocarcinoma of the pancreas: analysis of histopathology and outcome. Int J Gastrointest Cancer. 2003;34(2-3):121-8. doi: 10.1385/IJGC:34:2-3:121.
- Pingpank JF, Hoffman JP, Ross EA, Cooper HS, Meropol NJ, Freedman G, Pinover WH, LeVoyer TE, Sasson AR, Eisenberg BL. Effect of preoperative chemoradiotherapy on surgical margin status of resected adenocarcinoma of the head of the pancreas. J Gastrointest Surg. 2001 Mar-Apr;5(2):121-30. doi: 10.1016/s1091-255x(01)80023-8.
- White RR, Xie HB, Gottfried MR, Czito BG, Hurwitz HI, Morse MA, Blobe GC, Paulson EK, Baillie J, Branch MS, Jowell PS, Clary BM, Pappas TN, Tyler DS. Significance of histological response to preoperative chemoradiotherapy for pancreatic cancer. Ann Surg Oncol. 2005 Mar;12(3):214-21. doi: 10.1245/ASO.2005.03.105. Epub 2005 Mar 3.
- Breslin TM, Hess KR, Harbison DB, Jean ME, Cleary KR, Dackiw AP, Wolff RA, Abbruzzese JL, Janjan NA, Crane CH, Vauthey JN, Lee JE, Pisters PW, Evans DB. Neoadjuvant chemoradiotherapy for adenocarcinoma of the pancreas: treatment variables and survival duration. Ann Surg Oncol. 2001 Mar;8(2):123-32. doi: 10.1007/s10434-001-0123-4.
- Crane unpublished data presented at ASCO GI, 2006-Abstract # 106; Das, P., et al.).
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2009
Primärt slutförande (Faktisk)
17 augusti 2017
Avslutad studie (Faktisk)
17 augusti 2017
Studieregistreringsdatum
Först inskickad
30 september 2008
Först inskickad som uppfyllde QC-kriterierna
30 september 2008
Första postat (Uppskatta)
1 oktober 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 september 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 september 2017
Senast verifierad
1 september 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UFPTI 0704-PC02
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