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Pancreatic CancerPhase 2NCT02598349

Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas

A Phase 2 study testing Proton Radiation, Capecitabine and Surgical resection in people with Pancreatic Cancer, run by Proton Collaborative Group at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Proton Radiation, Capecitabine and Surgical resection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesUnited States
Study dates
Apr 2016to Oct 2040
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy proven unresectable adenocarcinoma of the pancreas.
  • Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
  • A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
  • Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
  • Required pretreatment laboratory parameters:
  • Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3
Show all 10Show fewer
  • Platelet count ≥ 100,000/mm3
  • Bilirubin < 2 mg/dl
  • ALT/SGPT < 3x upper limit of normal
  • Creatinine < 3 mg/dl

Who cannot join

  • Evidence of distant metastasis.
  • Prior surgical resection.
  • Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration.
  • Active or untreated infection,
  • Pregnant or breastfeeding women or subjects of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter.
  • Previous Radiation to the abdomen.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States4 sites, 3 recruiting

  • McLaren Proton Therapy Center

    Flint, Michigan, 48532

    Taylor Brewer, 313-576-8526, brewert@karmanos.org

    Brian Yeh, MD

    Recruiting

  • University of Florida Proton Therapy Institute

    Jacksonville, Florida, 32206

    Active, not recruiting

  • Proton Center of Arkansas

    Little Rock, Arkansas, 72205

    Monica Coleman, 501-686-8274, mmcoleman@uams.edu

    Fen Xia, MD

    Recruiting

  • Northwestern Medicine Chicago Proton Center

    Warrenville, Illinois, 60555

    Don Smith, MS, CCRC, 630-933-7820, donald.smith3@nm.org

    Nasiruddin Mohammed, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Trial of Escalated Dose Proton Radiotherapy With Elective Nodal Irradiation and Concomitant Chemotherapy for Patients With Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma

The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).

Read the detailed description

Participants as part of this research study will receive Proton radiation over 6 weeks with oral chemotherapy (capecitabine) only taken on radiation days.

In addition, If surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy.

Being tested
Proton Radiation, Capecitabine, Surgical resection
Keywords
Unresectable, Borderline resectable
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proton RadiationRadiation

    Also called Proton Beam Radiation

    Proton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.

  • CapecitabineDrug

    Also called Xeloda

    Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.

  • Surgical resectionProcedure or surgery

    Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.

Study groups in NCT02598349
Study groupRoleWhat they receive
Proton Radiation with capecitabineExperimentalThe following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.
Receives: Radiation: Proton Radiation; Drug: Capecitabine; Procedure: Surgical resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival at 12 months after radiation therapy

    The trial is designed to allow detection of an improvement in the 12 month overall survival rate to 75% compared to the expected historical rate of 50%.

    Measured: Approximately 12 months after radiation therapy.

Secondary outcomes (1)

  1. Surgical resection rate.

    Increase share of marginally resectable and unresectable patients being converted to resectable.

    Measured: 3 months following the completion of radiation therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2015 (estimated)
  2. Study startApr 2016
  3. Primary completionOct 2039 (estimated)
  4. Study completionOct 2040 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02598349
Sponsor's protocol ID
PAN009-18
Other IDs
UFPTI-1510-PC04
Status last verified
Sep 2026
First submitted
4 Nov 2015
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Katz MH, Pisters PW, Evans DB, Sun CC, Lee JE, Fleming JB, Vauthey JN, Abdalla EK, Crane CH, Wolff RA, Varadhachary GR, Hwang RF. Borderline resectable pancreatic cancer: the importance of this emerging stage of disease. J Am Coll Surg. 2008 May;206(5):833-46; discussion 846-8. doi: 10.1016/j.jamcollsurg.2007.12.020. Epub 2008 Mar 17.

    PubMed 18471707

  • Ashman JB, Moss AA, Rule WG, Callister MG, Reddy KS, Mulligan DC, Collins JM, De Petris G, Gunderson LL, Borad M. Preoperative chemoradiation and IOERT for unresectable or borderline resectable pancreas cancer. J Gastrointest Oncol. 2013 Dec;4(4):352-60. doi: 10.3978/j.issn.2078-6891.2013.006.

    PubMed 24294506

  • R. C. Nichols, C. G. Morris, D. Bose, S. J. Hughes, J. A. Stauffer, S. A. Celinski, R. C. Martin II, E. A. Johnson, R. A. Zaiden, M. S. Rutenberg ;O51: Feasibility of pancreatectomy after high dose proton therapy for unresectable pancreatic cancer. (2014) Proceedings to the 1 Annual Meeting for the Particle Therapy Cooperative Group - North America (PTCOG-NA), 27-29 October 2014. International Journal of Particle Therapy: Winter 2014, Vol. 1, No. 3, pp. 759-824.

  • Pawlik TM, Gleisner AL, Cameron JL, Winter JM, Assumpcao L, Lillemoe KD, Wolfgang C, Hruban RH, Schulick RD, Yeo CJ, Choti MA. Prognostic relevance of lymph node ratio following pancreaticoduodenectomy for pancreatic cancer. Surgery. 2007 May;141(5):610-8. doi: 10.1016/j.surg.2006.12.013. Epub 2007 Mar 23.

    PubMed 17462460

  • Winter JM, Brennan MF, Tang LH, D'Angelica MI, Dematteo RP, Fong Y, Klimstra DS, Jarnagin WR, Allen PJ. Survival after resection of pancreatic adenocarcinoma: results from a single institution over three decades. Ann Surg Oncol. 2012 Jan;19(1):169-75. doi: 10.1245/s10434-011-1900-3. Epub 2011 Jul 15.

    PubMed 21761104

  • Lee RY, Nichols RC Jr, Huh SN, Ho MW, Li Z, Zaiden R, Awad ZT, Ahmed B, Hoppe BS. Proton therapy may allow for comprehensive elective nodal coverage for patients receiving neoadjuvant radiotherapy for localized pancreatic head cancers. J Gastrointest Oncol. 2013 Dec;4(4):374-9. doi: 10.3978/j.issn.2078-6891.2013.043.

    PubMed 24294509

  • Dholakia AS, Kumar R, Raman SP, Moore JA, Ellsworth S, McNutt T, Laheru DA, Jaffee E, Cameron JL, Tran PT, Hobbs RF, Wolfgang CL, Herman JM. Mapping patterns of local recurrence after pancreaticoduodenectomy for pancreatic adenocarcinoma: a new approach to adjuvant radiation field design. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):1007-15. doi: 10.1016/j.ijrobp.2013.09.005.

    PubMed 24267969

  • Rapp CT, Rutenberg MS, Morris CG, Nichols RC. Dose-escalated proton therapy with elective nodal irradiation and concomitant chemotherapy for unresectable, borderline resectable, or medically inoperable pancreatic cancer: a phase II trial. J Gastrointest Oncol. 2022 Jun;13(3):1395-1401. doi: 10.21037/jgo-21-593.

    PubMed 35837200

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Proton Radiation, Capecitabine and Surgical resection in people with Pancreatic Cancer, run by Proton Collaborative Group at 4 sites 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 6 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival at 12 months after radiation therapy (time frame: Approximately 12 months after radiation therapy.). 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 NCT02598349, which also lists 8 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 29 Sep 2026.

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