Clinical trial NCT01754623: GTX-RT in Borderline Resectable Pancreatic Cancer
Official title: Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreas
Pancreatic
Neoplasms
Stereotactic
Radiosurgery
Borderline
Resectable
Gastrointestinal
Gemcitabine
Capecitabine
Fluorouracil
Docetaxel
SBRT
GTX Chemotherapy
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at participant's tumor followed by more chemotherapy can increase the chances that the participant's pancreatic tumor can be removed completely.

Detailed description: 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.

Eligibility criteria: 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 \</= 180°
  * circumferential tumor abutment with the superior mesenteric artery (SMA) over \</= 180°
  * 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 \</= 2 (Karnofsky \>/= 60%)
* 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 requirements
* Patients must not have any comorbid inflammatory conditions of the bowel such as Crohn's Disease.

Primary outcomes:
measure: Margin-negative (R0) Resection Rate
timeFrame: Up to 3 years
Secondary outcomes:
measure: Progression-Free Survival (PFS) at Three Years
timeFrame: 3 years
measure: Overall Survival (OS) Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Ravi Shridhar, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strom T, Hoffe SE, Fulp W, Frakes J, Coppola D, Springett GM, Malafa MP, Harris CL, Eschrich SA, Torres-Roca JF, Shridhar R. Radiosensitivity index predicts for survival with adjuvant radiation in resectable pancreatic cancer. Radiother Oncol. 2015 Oct;117(1):159-64. doi: 10.1016/j.radonc.2015.07.018. Epub 2015 Jul 30.