Phase II Study of First-line SBRT in Patients With Non-Metastatic Unresectable Pancreatic Cancer

NCT01434550 | Withdrawn DMC

• 1 other identifier: MCC-16459
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer and to find out what effects, good and/or bad, this treatment will have on participants and their cancer.

Conditions

Pancreatic Tumor

Keywords

pancreas; pancreatic cancer; SBRT; stereotactic body radiation; radiation therapy; unresectable; non-metastatic; tissue, blood, research imaging; TBRI

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Survival (OS)

  Patients will be followed for 36 months to determine overall survival even after completion of the experimental portion of the protocol. Patients will be followed every 3 months. All patients will be referred for chemotherapy at the completion of radiation.

  36 Months

Secondary Outcomes (2)

• Number of Participants With Reduction in Size of Primary Tumor

  12 Months

• Number of Participants With Adverse Events (AEs)

  36 Months

Study Arms (2)

TBRI Subgroup: TBRI and SBRT

ACTIVE COMPARATOR

Six patients will be asked to be part of a subgroup called TBRI (Tissue, Blood, Research Imaging). In this subgroup, we want to study if there is early death of tumor cells from the treatment by looking at the tumor using PET/CT scans and biopsies, and by testing the participant's body's white blood cells taken by a procedure called leukapheresis. Participants do not have to take part in the TBRI subgroup to get treatment on this study with SBRT. SBRT: 1. 30 Gy in 5 fractions to pancreatic tumor 2. 50 Gy in 5 daily consecutive fractions unresectable portion and avoiding bowel, stomach, and duodenum

Radiation: Stereotactic Body Radiation Therapy (SBRT); Radiation: Tissue, Blood, Research Imaging (TBRI)

SBRT Alone

ACTIVE COMPARATOR

1. 30 Gy in 5 fractions to pancreatic tumor 2. 50 Gy in 5 daily consecutive fractions unresectable portion and avoiding bowel, stomach, and duodenum

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

Everyone who takes part in this study will receive SBRT. After making an individual radiation plan for each participant, they will receive 5 days of radiation to the pancreas. Participants will have follow-up visits with blood tests one month after the end of SBRT and then every 3 months for 3 years. They will also have CT scans (chest and pancreas) and FDG PET/CT (body) at 1 month and then at 3, 6, 9 and 12 months.

Also known as: extracranial lesions, high-dose fractions, radiosurgery

SBRT Alone; TBRI Subgroup: TBRI and SBRT

Tissue, Blood, Research Imaging (TBRI) RADIATION

Post-SBRT procedures (day 1, 3, 5 of SBRT, and 4 weeks after) A) Endoscopic or CT guided biopsy of treated pancreatic cancer to assess 1. Necrosis/apoptosis 2. Lymphocyte infiltrate and antigen presenting cells B) Imaging to evaluate cell death (day 1, 3, 5 of SBRT, and 4 weeks after) 1\. Aposense-PET imaging

Also known as: CT guided biopsy, Imaging to evaluate cell death, Aposense-PET imaging

TBRI Subgroup: TBRI and SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven, non-metastatic, pancreatic cancer
• Unresectable disease based on institutional standardized criteria for unresectability
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• CT scan of chest and abdomen (3-phase pancreas protocol), and PET-CT within 4 weeks of study entry
• Patients with biliary or gastroduodenal obstruction must have drainage, duodenal stenting, or gastric bypass prior to initiating radiation
• All disease must be encompassed in a single radiation field
• No evidence or history of an autoimmune dysfunction
• Negative pregnancy test within 7 days of study entry
• No prior or concurrent chemotherapy
• No previous or concurrent immunotherapy for pancreatic cancer
• Liver enzymes ≤ 3 times upper limit of normal (ULN): total bilirubin (Tbili) ≤ 3.9 (biliary stents are allowed); aspartic transaminase (AST) ≤ 177; alanine transaminase (ALT) ≤ 198; Alkaline phosphatase (ALK-P) ≤ 378
• Adequate pretreatment organ function: Creatinine no greater than 1.5mg/dL; Total calcium no greater than 11.0mg/dL; prothrombin time (PT) no greater then 14 seconds; partial thromboplastin time (PTT) no greater then 40 seconds
• Ability to give informed consent
• Adequate baseline hematopoietic function: total white blood cell count equal to or greater than 3,000/mm³; absolute granulocyte count greater than 1,500/mm³; absolute lymphocyte count greater than 500/mm³; platelet count equal to or greater than 100,000/mm³
• Amenable to leukapheresis as determined by a leukapheresis nurse

You may not qualify if:

• Prior history of radiotherapy that overlaps with the planned ports to the primary pancreatic tumor
• Patients with tumors that are not accessible to direct access cannot be included in the study.
• Prior or concurrent chemotherapy
• Prior history of antineoplastic therapy or irradiation
• Prior treatment with anti-tumor vaccines not allowed
• Patients with a history of autoimmune diseases
• A history of HIV infection, AIDS or other immunosuppressive disease state. The need to exclude patients with HIV/AIDS is because one of the endpoints of the study is immune response. People with HIV have a compromised immune system and enrollment in this study could confound the results (TBRI only)
• Patients requiring corticosteroids are ineligible because one of the endpoints of the study is immune response. Since steroids modulate the immune system, enrollment of patients on steroids could confound the results. There must be no use of corticosteroids in the fours weeks preceding entry into the study (TBRI only).
• Active bacterial, fungal or viral infection
• Active bleeding (hemoptysis, melena, etc.)
• Women who are currently pregnant or actively breast feeding. Women of childbearing potential must have a negative serum pregnancy test and must use effective contraception during trial participation
• Any medical or psychiatric illness which in the opinion of the principal investigator might compromise a patient's ability to tolerate or complete treatment
• Any patient requiring blood thinners (due to risk of gastrointestinal \[GI\] bleed)

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery; Histocompatibility Testing; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques; Specimen Handling; Punctures

Study Officials

• Ravi Shridhar, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 15, 2011
• Study Start: March 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 23, 2017

Record last verified: 2017-02