Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— PC03  

Official title:

A Phase II Trial of Postoperative Proton Radiotherapy With Concomitant Chemotherapy for Patients With Resected Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553019
• Other study ID #: UFPTI 1013-PC03
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2011
• Last updated: September 1, 2017
• Start date: October 2011
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy has on resected pancreatic cancer.

Description:

Proton radiation with concomitant chemotherapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection

• Post resection CA19-9 tumor marker baseline

Exclusion Criteria:

• Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the patient has been disease free for at least 5 years prior to study consent

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• Proton radiation
Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction

Drug:
• Gemcitabine
Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida
United States	Provision Proton Therapy Center	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (8)

Gudjonsson B. Cancer of the pancreas. 50 years of surgery. Cancer. 1987 Nov 1;60(9):2284-303. — View Citation

Hattangadi JA, Hong TS, Yeap BY, Mamon HJ. Results and patterns of failure in patients treated with adjuvant combined chemoradiation therapy for resected pancreatic adenocarcinoma. Cancer. 2009 Aug 15;115(16):3640-50. doi: 10.1002/cncr.24410. — View Citation

Kalser MH, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg. 1985 Aug;120(8):899-903. Erratum in: Arch Surg 1986 Sep;121(9):1045. — View Citation

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. — View Citation

Nichols RC Jr, Huh SN, Prado KL, Yi BY, Sharma NK, Ho MW, Hoppe BS, Mendenhall NP, Li Z, Regine WF. Protons offer reduced normal-tissue exposure for patients receiving postoperative radiotherapy for resected pancreatic head cancer. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):158-63. doi: 10.1016/j.ijrobp.2011.05.045. Epub 2012 Jan 13. — View Citation

Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. doi: 10.1001/jama.299.9.1019. Erratum in: JAMA. 2008 Apr 23/30;299(16):1902. — View Citation

Tepper J, Nardi G, Sutt H. Carcinoma of the pancreas: review of MGH experience from 1963 to 1973. Analysis of surgical failure and implications for radiation therapy. Cancer. 1976 Mar;37(3):1519-24. — View Citation

Van Laethem JL, Hammel P, Mornex F, Azria D, Van Tienhoven G, Vergauwe P, Peeters M, Polus M, Praet M, Mauer M, Collette L, Budach V, Lutz M, Van Cutsem E, Haustermans K. Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study. J Clin Oncol. 2010 Oct 10;28(29):4450-6. doi: 10.1200/JCO.2010.30.3446. Epub 2010 Sep 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Toxicity	Assessment of acute/late severe (defined as grade 3-5) radiation toxicity at the completion of therapy. Acute toxicity will be defined to be toxicity occurring within 90 days from the start of radiation treatment, and late toxicity will be defined as toxicity occurring more than 90 days from the start of radiation treatment.	90 days after completion of RT
Secondary	Survival Rate	One year overall survival rate	1 year after completion of RT
Secondary	Response rate via CA 19-9		Every 3 months for 2 years, then every 6 months for 3-5 years then annually thereafter

External Links

•   (Contact the University of Florida Proton Therapy Institute)