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Trial record 54 of 266 for:    Pancreatic Cancer AND Resectable

Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03492671
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Naveenraj Solomon, MD, Loma Linda University

Brief Summary:
The purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational portion of this study is providing the chemotherapy drugs and radiation therapy before surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.

Condition or disease Intervention/treatment Phase
Pancreas Adenocarcinoma Resectable Pancreatic Cancer Drug: Gemcitabine 1000 mg Drug: nab-paclitaxel Radiation: Stereotactic Body Radiation Therapy Phase 2

Detailed Description:

Primary Endpoint: R0 resection rate ≥ 70%

Secondary Endpoints: Disease free survival, Overall survival, Perioperative mortality and morbidity

Treatment should start within 28 days of registration. Pre-operative Chemotherapy Patients will receive a combination of the agents (gemcitabine and nab-paclitaxel) prior to surgery for a maximum of four cycles.

Gemcitabine 1000 mg-m2 IV on days 1, 8, 15 Nab-paclitaxel 125 mg-m2 IV on days 1, 8, 15 28 day cycles

Post-operative Chemotherapy Treatment should start within 5-10 weeks of surgery. Patients will receive a combination of the agents (gemcitabine and nab-paclitaxel) after surgery for maximum of two cycles.

Gemcitabine 1000 mg-m2 IV on days 1, 8, 15 Nab-paclitaxel 125 mg-m2 IV on days 1, 8, 15 28 day cycles

Radiation Therapy Immobilization and Treatment Planning CT Scan All patients will be immobilized in a full body immobilization device in the supine position.

A 4D-CT scan from T5 to L5-S1 with intravenous and oral contrast will be performed.

Radiation Toxicity All acute toxicities will be scored according to the NCI Common Toxicity Criteria v4.0. Late toxicity will be scored per RTOG guidelines.

Surgery, Pre-operative Re-staging Pre-operative evaluation should occur within 2-4 weeks prior to the planned surgery date. Based on the results of the pre-operative evaluation, the corresponding action below should be taken.

Radiological responding or stable disease: Patients should proceed to surgery per protocol.

Surgery Pancreatic resection should occur within 4-10 weeks after the last dose of preoperative chemotherapy or SBRT. Staging laparoscopy may be performed at the time of planned laparotomy but is not required.

Post-operative Restaging Evaluation should occur within 2 weeks prior to initiation of postoperative chemotherapy.

Tumor Response Evaluation (Adapted From RECIST 1.1) Assessment of overall tumor burden and measurable disease To assess objective response or future progression, it is necessary to estimate the overall tumor burden at baseline and use this as a comparator for subsequent measurements. Only patients with measurable disease at baseline should be included in protocols where objective tumor response is the primary endpoint. Measurable disease is defined by the presence of at least one measurable. In studies where the primary endpoint is tumor progression (either time to progression or proportion with progression at a fixed date), the protocol must specify if entry is restricted to those with measurable disease or whether patients having non-measurable disease only are also eligible.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Pre-operative Chemotherapy (With Gemcitabine and Nab- Paclitaxel) and Stereotactic Body Radiotherapy Followed by Surgery and Chemotherapy in Patients With Resectable Pancreatic Adenocarcinoma
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chemotherapy and SBRT

Pre-Operative Chemotherapy: Within 28 days of study enrollment, subjects will receive a combination of Gemcitabine and Nab-paclitaxel for a maximum of four 28-day cycles. Gemcitabine 1000 mg/m2 IV on Days 1,8,15. Nab-paclitaxel 125 mg/m2 on Days 1,8,15.

Post-Operative Chemotherapy: Within 5-10 weeks after surgery, subjects will receive a combination of Gemcitabine and Nab-paclitaxel for a maximum of two 28-day cycles. Gemcitabine 1000 mg/m2 IV on Days 1,8,15. Nab-paclitaxel 125 mg/m2 on Days 1,8,15.

Standard Stereotactic Body Radiation Therapy (SBRT) fractionation of 6 Gy per day will be used for all patients to a total dose of 30 Gy.

Drug: Gemcitabine 1000 mg
Pre-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)

Drug: nab-paclitaxel
Pre-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)

Radiation: Stereotactic Body Radiation Therapy
Standard Stereotactic Body Radiation Therapy (SBRT) fractionation of 6 Gy per day will be used for all patients to a total dose of 30 Gy.
Other Name: SBRT




Primary Outcome Measures :
  1. Curative Intent Resection (R0) rate [ Time Frame: Within 2 weeks prior to initiation of post-operative chemotherapy. ]
    Measure the rate of R0 resection with all margins microscopically clear.


Secondary Outcome Measures :
  1. Disease Free Survival Rate [ Time Frame: Every three months up to two years after resection. ]
    Subject will be followed post-resection for evidence of pancreatic cancer.

  2. Overall Survival Rate [ Time Frame: Every six months up to 6 years post-resection. ]
    Subject will be followed post-resection for overall survival rate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (all criteria must apply):

  • Cytologic or histologic proof of adenocarcinoma of the pancreas.
  • Localized, potentially resectable tumors.
  • Greater or equal to 18 years of age.
  • ECOG performance status of 0 or 1.
  • Adequate hematologic, renal and hepatic function as defined by:
  • ANC greater or equal to 1,500 cells/mm3
  • Platelets greater or equal to 100,000 cells/mm3
  • Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Serum creatinine ≤ 2 x ULN • ALT ≤ 5 x ULN
  • AST ≤ 5 x ULN
  • No history of prior therapy for pancreatic cancer.
  • No history of active infection requiring IV antibiotics at the start of study treatment
  • Non-pregnant and non-breast-feeding.

Exclusion Criteria:

  • Patient has borderline resectable or metastatic disease.
  • History of malignancy in the last 5 years other than in situ cancer or basal or squamous cell skin cancer or malignancies cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
  • Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492671


Contacts
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Contact: Naveenraj Solomon, MD 909-558-5498 nsolomon@llu.edu
Contact: Shagufta Shaheen, MD 909-558-4050 sshaheen@llu.edu

Locations
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United States, California
Loma Linda University Health Recruiting
Loma Linda, California, United States, 92354
Contact: Naveenraj Solomon, MD       nsolomon@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Naveenraj Solomon, MD Loma Linda University Cancer Center

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Responsible Party: Naveenraj Solomon, MD, Primary Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT03492671     History of Changes
Other Study ID Numbers: 5170277
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Naveenraj Solomon, MD, Loma Linda University:
Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs