High or Standard Intensity Radiation Therapy After Gemcitabine Hydrochloride and Nab-paclitaxel in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery

PHASE2TerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Pancreatic AdenocarcinomaStage III Pancreatic Cancer
Interventions
RADIATION

low intensity radiation therapy

50.4 Gy in 28 1.8 Gy fractions (IMRT or 3D-CRT), 5 days/week, starting 3-5 weeks after the last dose of induction chemotherapy

DRUG

Capecitabine

825 mg/m2 PO twice daily, 5 days/week, beginning on the first day of radiation therapy and ending on the last day of radiation therapy.

DRUG

Gemcitabine

1000 mg/m2 weekly as a 30 minute infusion after nab-Paclitaxel, three weeks on and 1 week off \[1 cycle = 4 weeks\]

RADIATION

high intensity radiation therapy

63 Gy intensity-modulated radiation therapy (IMRT) in 28 2.25 Gy fractions, 5 days/week, starts 3-5 weeks after the last dose of induction chemotherapy

DRUG

nab-Paclitaxel

125 mg/m2 weekly as a 30-40 minute infusion, three weeks on and 1 week \[1 cycle = 4 weeks\]

Trial Locations (46)

14642

University of Rochester, Rochester

19010

Bryn Mawr Hospital, Bryn Mawr

19096

Lankenau Medical Center, Wynnewood

19104

University of Pennsylvania/Abramson Cancer Center, Philadelphia

19301

Paoli Memorial Hospital, Paoli

19611

Reading Hospital, West Reading

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

30322

Emory University/Winship Cancer Institute, Atlanta

37916

Thompson Cancer Survival Center, Knoxville

44307

Akron General Medical Center, Akron

46804

Radiation Oncology Associates PC, Fort Wayne

46805

Parkview Hospital Randallia, Fort Wayne

50010

McFarland Clinic PC-William R Bliss Cancer Center, Ames

50309

Iowa Methodist Medical Center, Des Moines

54143

Bay Area Medical Center, Marinette

54301

Saint Vincent Hospital, Green Bay

54303

Saint Mary's Hospital, Green Bay

55905

Mayo Clinic, Rochester

56201

Rice Memorial Hospital, Willmar

56601

Sanford Clinic North-Bemidgi, Bemidji

58122

Roger Maris Cancer Center, Fargo

58501

Sanford Bismarck Medical Center, Bismarck

60657

Saint Joseph Hospital, Chicago

61637

OSF Saint Francis Medical Center, Peoria

62526

Decatur Memorial Hospital, Decatur

63141

Mercy Hospital Saint Louis, St Louis

65804

Mercy Hospital Springfield, Springfield

65807

CoxHealth South Hospital, Springfield

70121

Ochsner Medical Center Jefferson, New Orleans

77030

M D Anderson Cancer Center, Houston

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

84157

Intermountain Medical Center, Murray

84403

McKay-Dee Hospital Center, Ogden

94080

Kaiser Permanente Cancer Treatment Center, South San Francisco

94611

Kaiser Permanente Oakland-Broadway, Oakland

95051

Kaiser Permanente Medical Center - Santa Clara, Santa Clara

61615-7827

OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC, Peoria

02118

Boston Medical Center, Boston

48106-0995

Saint Joseph Mercy Hospital, Ann Arbor

08060

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County, Mount Holly

08534

Capital Health Medical Center-Hopewell, Pennington

02903

Rhode Island Hospital, Providence

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05602

Central Vermont Medical Center/National Life Cancer Treatment, Berlin Corners

05401

University of Vermont Medical Center, Burlington

54235-1495

Door County Cancer Center, Sturgeon Bay

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK

NCT01921751 - High or Standard Intensity Radiation Therapy After Gemcitabine Hydrochloride and Nab-paclitaxel in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery | Biotech Hunter | Biotech Hunter