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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02598349
• Other study ID #: PAN009-18
• Secondary ID: UFPTI-1510-PC04
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: October 2040

Study information

• Verified date: May 2024
• Source: Proton Collaborative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2040
• Est. primary completion date: October 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• Platelet count = 100,000/mm3

• Bilirubin < 2 mg/dl

• ALT/SGPT < 3x upper limit of normal

• Creatinine < 3 mg/dl

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

Radiation:
• Proton 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.

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

Procedure:
• Surgical resection
Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.

Locations

Country	Name	City	State
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	McLaren Proton Therapy Center	Flint	Michigan
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida
United States	Northwestern Medicine Chicago Proton Center	Warrenville	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Proton Collaborative Group	University of Florida Health

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	Approximately 12 months after radiation therapy.
Secondary	Surgical resection rate.	Increase share of marginally resectable and unresectable patients being converted to resectable.	3 months following the completion of radiation therapy.

External Links

•   Contact the University of Florida Proton Therapy Institute