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GTX-RT in Borderline Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01754623
Recruitment Status : Terminated (Lack of pre-treatment tissue to make the study plan feasible.)
First Posted : December 21, 2012
Results First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 21, 2012
Results First Submitted Date  ICMJE June 17, 2015
Results First Posted Date  ICMJE August 13, 2015
Last Update Posted Date August 13, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2015)
Margin-negative (R0) Resection Rate [ Time Frame: Up to 3 years ]
R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • Margin-negative (R0) Resection Rate [ Time Frame: 3 years ]
    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).
  • Overall Survival (OS) Rate [ Time Frame: 3 years ]
    OS will be calculated from date of enrollment to date of death from any cause. Investigators will also compare OS between resected and non-resected patients. Comparative analysis will be performed by Kaplan-Meier analysis and 2-sided log-rank test.
Change History Complete list of historical versions of study NCT01754623 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2015)
  • Progression-Free Survival (PFS) at Three Years [ Time Frame: 3 years ]
    PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the longest diameter (LD) of the target lesion or appearance of new lesions at metastatic sites.
  • Overall Survival (OS) Rate [ Time Frame: 12 months ]
    OS at time of analysis, calculated from date of enrollment to date of death from any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Progression-Free Survival (PFS) [ Time Frame: 3 years ]
Progression-Free Survival (PFS) PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Investigators will also compare PFS between resected and non-resected patients. Comparative analysis will be performed by Kaplan-Meier analysis and 2-sided log-rank test.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GTX-RT in Borderline Resectable Pancreatic Cancer
Official Title  ICMJE Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Capecitabine
    Treatment will begin with the first round of chemotherapy. Each round of chemotherapy will take 21 days. Each round or cycle will start with participants taking capecitabine pills. Participants will take tablets of capecitabine (Xeloda®) twice per day for 14 days followed by 7 days without capecitabine.
    Other Name: Xeloda®
  • Drug: Gemcitabine
    On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. First, this will consist of placing gemcitabine (Gemzar®) in a bag of fluid and giving it by vein over 30 minutes.
    Other Name: Gemzar®
  • Drug: Docetaxel
    On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. After the gemcitabine, participants will receive docetaxel (Taxotere®) in a bag of fluid over 1 hour.
    Other Name: Taxotere®
  • Radiation: Stereotactic body radiation therapy (SBRT)
    30/40 Gy to pancreatic tumor/area of borderline resectability
    Other Name: SBRT
  • Other: Restaging review after radiation
    After radiation, participants will be re-evaluated for surgery. Patients who have Complete Response (CR), Partial Response (PR) or stable disease (SD) will proceed with surgical exploration and resection provided they are suitable fit for surgery in the judgment of the surgical oncologist. Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT). If no surgery: then chemotherapy. If surgery: chemotherapy will be given based on response.
  • Procedure: Surgery
    Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery. After surgery, chemotherapy will be given based on response.
  • Drug: 5-Fluorouracil
    Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT).
Study Arms  ICMJE Experimental: Chemotherapy Followed by Radiation Treatment

Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).

After radiation, participants will be re-evaluated for surgery.

Interventions:
  • Drug: Capecitabine
  • Drug: Gemcitabine
  • Drug: Docetaxel
  • Radiation: Stereotactic body radiation therapy (SBRT)
  • Other: Restaging review after radiation
  • Procedure: Surgery
  • Drug: 5-Fluorouracil
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 20, 2014)
9
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2012)
35
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01754623
Other Study ID Numbers  ICMJE MCC-16932
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ravi Shridhar, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP