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Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT)

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT)

Investigators plan to conduct a prospective pilot phase II trial of GTX-SBRT as neoadjuvant
treatment of borderline resectable pancreatic cancer. After informed consent, pretreatment
pancreatic tumor tissues will be collected and immediately frozen at the time of staging
endoscopic ultrasound (EUS). Ribonucleic acid (RNA) will be extracted from tumor specimens
and run on microarray analysis to determine radiosensitivity index score. Borderline
resectable (BR) patients will be treated with 3 cycles of GTX chemotherapy followed by SBRT.
They will be restaged and evaluated for resectability 3 to 4 weeks later. Non-metastatic
patients who are deemed resectable after neoadjuvant therapy will be taken to surgery.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed pancreatic
adenocarcinoma that is borderline resectable disease. Borderline resectable lesions
are defined as:

- circumferential tumor abutment with the superior mesenteric vein (SMV) or portal
vein (PV) or SMV/PV confluence over
- circumferential tumor abutment with the superior mesenteric artery (SMA) over

- Short segment encasement (360°) of the PV or SMV that is amenable to partial
vein resection and reconstruction

- encasement of the gastroduodenal artery up to the origin of the hepatic artery

- Patients must have measurable disease

- No previous chemotherapy or radiation to the pancreas

- Eastern Cooperative Oncology Group (ECOG) performance status /=

- Patients must have normal organ and marrow function as defined below:

- leukocytes >/= 3,000/μL

- absolute neutrophil count >/= 1,000/ μL

- platelets >/= 100,000/ μL

- creatinine within normal institutional limits (ULN)

- total bilirubin will allow for 2x the upper limit of the institution. Patients
may have biliary stents or drains to lower total bilirubin to this range.

- Has a negative serum or urine pregnancy test within 7 days prior to initiation of
therapy (female patients of childbearing potential). Postmenopausal women must have
been amenorrheic for at least 12 months to be considered of non-childbearing
potential. Patients will agree to continue contraception for 30 days from the date of
the last study drug administration.

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients with metastatic disease are ineligible.

- Patients who have had prior chemotherapy for pancreatic adenocarcinoma

- Patients who have received prior radiation to an abdominal site are not eligible.

- Patients with peripheral neuropathy >/= grade 2

- Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel),
other drugs formulated with polysorbate 80, gemcitabine, or capecitabine

- Patients may not be receiving any other investigational agents.

- ECOG Performance Status 3-4

- Pregnant or breast-feeding women are excluded from this study because
gemcitabine,capecitabine, and docetaxel are Class D agents with the potential for
teratogenic or abortifacient effects.

- Uncontrolled intercurrent illness including, but not limited to, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
psychiatric illness/social situations that would limit compliance with study

- Patients must not have any comorbid inflammatory conditions of the bowel such as
Crohn's Disease.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Margin-negative (R0) Resection Rate

Outcome Description:

The primary endpoint is correlation of a radiosensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response); R1 (Moderate Response); R2 (Minimal Response); R3 (No Response).

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Ravi Shridhar, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

February 2013

Completion Date:

December 2016

Related Keywords:

  • Pancreatic Cancer
  • Pancreas
  • Pancreatic
  • Neoplasms
  • Stereotactic
  • Radiosurgery
  • Borderline
  • Resectable
  • Gastrointestinal
  • Gemcitabine
  • Capecitabine
  • Fluorouracil
  • Docetaxel
  • SBRT
  • GTX Chemotherapy
  • Pancreatic Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612