"Pancreas Cancer: Molecular Profiling as a Guide to Therapy Before and After Surgery (Personalized Medicine)"

PHASE2CompletedINTERVENTIONAL
Enrollment

229

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

June 30, 2018

Study Completion Date

April 11, 2022

Conditions
Pancreatic Adenocarcinoma
Interventions
DRUG

Milestone 1: Targeted chemotherapy prior to surgery

The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.

RADIATION

Milestone 2: Chemoradiotherapy (cXRT)

A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or intensity-modulated radiation therapy (IMRT) techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

DRUG

Milestone 3: Targeted chemotherapy prior to surgery

The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.

RADIATION

Milestone 3: Chemoradiotherapy (cXRT)

A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

DRUG

Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery

A biopsy of the borderline tumor does not provide a molecular profile that can be used to target treatment. The treatment will be standard FOLFIRINOX chemotherapy regimen.

RADIATION

Milestone 4: Chemoradiotherapy (cXRT)

A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

DRUG

Milestone 5: Targeted chemotherapy after surgery

The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.

RADIATION

Milestone 5: Chemoradiotherapy (cXRT)

A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

DRUG

Milestone 6: Gemcitabine after surgery

Chemotherapy treatment with Gemcitabine.

RADIATION

Milestone 6: Chemoradiotherapy (cXRT)

A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

RADIATION

Milestone 7: Chemoradiotherapy (cXRT)

A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).

DRUG

Milestone 8: Targeted chemotherapy after surgery

The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.

DRUG

Milestone 9: Gemcitabine after surgery

Chemotherapy treatment with Gemcitabine.

OTHER

Milestone 10: No additional therapy after surgery

The molecular profile of the tumor that was removed during surgery points to a lack of treatment affect for available therapies. No additional therapy is recommended.

Trial Locations (2)

45221

University of Cincinnati Cancer Center, Cincinnati

53226

Froedtert and The Medical College of Wisconsin, Milwaukee

All Listed Sponsors
collaborator

University of Cincinnati

OTHER

lead

Medical College of Wisconsin

OTHER

NCT01726582 - "Pancreas Cancer: Molecular Profiling as a Guide to Therapy Before and After Surgery (Personalized Medicine)" | Biotech Hunter | Biotech Hunter