NCT01553019

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2 pancreatic-cancer

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

5.9 years

First QC Date

October 21, 2011

Last Update Submit

September 1, 2017

Conditions

Pancreatic Cancer

Keywords

Proton radiationChemotherapyPancreatic cancerPostoperative

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Survival Rate

    1 year after completion of RT

  • Response rate via CA 19-9

    Every 3 months for 2 years, then every 6 months for 3-5 years then annually thereafter

Study Arms (3)

1- R(0) negative

EXPERIMENTAL

50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine

Radiation: Proton radiationDrug: Gemcitabine

2- R(1) micro-positive

EXPERIMENTAL

54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine

Radiation: Proton radiationDrug: Gemcitabine

3- R(2) gross positive

EXPERIMENTAL

59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine

Radiation: Proton radiationDrug: Gemcitabine

Interventions

Proton radiationRADIATION

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

1- R(0) negative2- R(1) micro-positive3- R(2) gross positive
GemcitabineDRUG

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

Also known as: Gemzar
1- R(0) negative2- R(1) micro-positive3- R(2) gross positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection
  • Post resection CA19-9 tumor marker baseline

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Provision Proton Therapy Center

Knoxville, Tennessee, 37909, United States

Location

Related Publications (8)

  • 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. doi: 10.1002/1097-0142(197603)37:33.0.co;2-o.

    PMID: 1260670BACKGROUND

  • Gudjonsson B. Cancer of the pancreas. 50 years of surgery. Cancer. 1987 Nov 1;60(9):2284-303. doi: 10.1002/1097-0142(19871101)60:93.0.co;2-v.

    PMID: 3326653BACKGROUND

  • 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.

    PMID: 18319412BACKGROUND

  • Hattangadi et al Cancer 8/15/2009 p 3640-3650

    BACKGROUND

  • 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.

    PMID: 22245197BACKGROUND

  • Kalser MH, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg. 1985 Aug;120(8):899-903. doi: 10.1001/archsurg.1985.01390320023003.

    PMID: 4015380BACKGROUND

  • 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.

    PMID: 10615932BACKGROUND

  • Van Laethem JL, Van Cutsem E, Hammel P, Mornex F, Azria D, Van Tienhoven G, Peeters M, Praet M, Budach V, Haustermans K et al. Adjuvant chemotherapy alone vs. chemoradiation after curative resection for pancreatic cancer: phase II/III trial of the EORTC/FFCD/GERCOR groups.

    BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Proton TherapyGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeuticsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Romaine C Nichols, MD

    University of Florida Proton Therapy Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2011

First Posted

March 13, 2012

Study Start

October 1, 2011

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

US(2)