Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Fluorodeoxyglucose F18

Pancrelipase

Pancreatin

Antimetabolites

Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.

Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator

Stereotactic Body Radiotherapy

Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes

Patients will undergo this imaging procedure prior to treatment for planning purposes.

4D pancreatic protocol CT scan

Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.

FDG PET scan

Albert Koong

This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine

In this study, we propose to combine stereotactic body radiotherapy (SBRT) with standard gemcitabine chemotherapy. We hypothesize that earlier administration of systemic chemotherapy may prolong the interval to distant progression and improve overall survival in these patients. In this study, we will treat pancreatic cancer patients with locally advanced disease with 3 weeks of gemcitabine, followed by Trilogy(TM) SBRT and additional gemcitabine. 30 patients will be accrued to this study at Stanford University Medical Center, the only site participating in this research study. Treatment on this protocol requires placement of 3-5 gold (99.9% pure) fiducials for targeting purposes. Four to 7 days after placement of the fiducials, patients will then undergo a 4D pancreatic protocol CT scan through the upper abdomen. In addition, an FDG PET scan is required for treatment planning purposes. This imaging set will be processed for radiosurgery, using a modified linac based radiation treatment planning system (EclipseTM). An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy prescribed to the isodose line that completely surrounds the gross pancreatic tumor volume (GTV) as defined by the contrast CT. Following SBRT, patients will be monitored clinically and radiographically.

Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer

The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site.

Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression.

The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves.

Associate Professor of Radiation Oncology

patient with locally advanced pancreas cancer receiving Gem + SBRT

SBRT With Gem

25 Gy single fraction dose using Trilogy linear accelerator

SBRT

Age, Categorical

Age, Continuous

Gender

United States

Region of Enrollment

Dr. Albert Koong

patients w/ pancreas Cancer receiving Stereotactic Radiosurgery and Gemcitabine

Stereotactic Radiosurgery

Rate of Local Control

single fraction 25 Gy dose Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine

Stereotactic Body Radiotherapy: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator

Gemcitabine: Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes

Median Overall Survival Time

patients that received a single fraction of 25 Gy Stereotactic Body Radiotherapy followed by weekly Gemcitabine administered at 1000mg/m2 over 100 minutes.

Patients will be followed at 4-6 weeks, 3 months, 6 months, 9 months and 1 year, in year 2 follow up will be every 4 months and in year 3 follow up will be every 6 months.

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Esophageal Neoplasms

Vulvar Neoplasms

Uterine Cervical Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Vulvar Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Esophageal Cancer

Vulvar Cancer

Research FDG-PET scan obtained before radiation therapy; a second research FDG-PET scan is obtained at about 3-5 weeks after treatment has started.

At radiation planning subjects will have a PET-CT. The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.

Eileen Duffy, RN BSN

Clinical Trials Office

Junzo Chino, MD

This study expands on protocol (NCT01908504"PET adaptive RT") designed to evaluate the utility of adaptive PET-CT planning for radiation therapy (RT). Radiation therapy is used in many malignant diseases as a curative treatment modality. However, critical normal tissue is often in close approximation to disease, and portions of such tissue must receive high doses of radiation for appropriate treatment.

Positron Emission Tomography (PET) adapted radiation therapy, as defined in the current protocol, may allow for a means of determining the eventual response to therapy, at a time point when adaptation of treatment plan may be possible to improve outcomes. This protocol will build upon the findings the previous protocol (NCT01908504 "PET adaptive RT") that evaluated the utility of intra-treatment PET imaging in multiple types of cancers. The current focus will be more specific to certain types of gastrointestinal and gynecologic cancers treated with RT, identified from the prior study to warrant further research.

Intra-treatment PETs have only recently been studied in small pilot series. In rectal cancer, a prospective trial from MSKCC demonstrated that a PET-CT obtained in the second week of neoadjuvant chemoradiotherapy was able to discriminate sub-optimal responders with a sensitivity of 94% and an accuracy of 78%, though the most useful metric was a novel "visual response score" based on interpreting radiologists scoring rather than more established objective data available from PET, like SUV. A study from China in non-small cell lung cancer found that decreases in SUV and MTV on intra-treatment PET-CTs after 40Gy of chemoradiation therapy were significantly greater in patients responding to treatment by post-treatment RECIST criteria. For head and neck cancers, a Belgian study found that intra-treatment SUVmax at 47Gy was associated with significant differences in overall survival. Therefore, there is emerging evidence that an intra-treatment PET may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly.

All participants will be required to complete two research PET scans in addition to standard of care planning CT's for radiation therapy. For all subjects with cancer of the cervix and vulva an intra-treatment PET-CT will be obtained and used to develop a volume adaptive treatment plan for the remainder of the course. Subjects with esophageal and anal canal cancer will have an adapted plan if the treating radiation oncologist determines an adapted plan is clinically relevant.

Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers

Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers ( Adaptive PET II)

This benefit lies in the potential to adapt the treatment plan based on an intratreatment PET-CT. This may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly

Pathologic complete response will be collected from pathology reports for subjects who have surgical resection after radiation therapy.

This study will evaluate the prognostic value of intra-treatment functional imaging on clinical relevant tumor endpoints (i.e. locoregional control, freedom from distant metastases, and overall survival).Comparison of intra-treatment FDG-PET indices will identify two groups of responses: PET responses and PET non-responses, which will correlate with prognosis.

Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care, or at the treating investigator's discretion. Frequency of follow up will be determined by the standard practice for the disease site and stage.

Subjects will be evaluated in regular follow up with the investigators according to the standard of care for each disease site

Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care for each disease site

An intra-treatment PET volume adaptive treatment plan may allow for additional sparing of normal tissue by identifying regions of tumor response and corresponding reduction in the target volumes i.e. dosimetric differences in normal tissue will be compared between the initial plan and the adapted plan.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer	NCT00350142	Pancreatic Canc...	Stereotactic Bo... Gemcitabine 4D pancreatic p... FDG PET scan	18 Years - 90 Years	Stanford University
Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer	NCT00350142	Pancreatic Canc...	Stereotactic Bo... Gemcitabine 4D pancreatic p... FDG PET scan	18 Years - 90 Years	Stanford University
Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers	NCT03403465	Cancer of the C... Vulvar Cancer Esophageal Canc... Anal Canal Canc...	FDG PET scan	18 Years -	Duke University
Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers	NCT03403465	Cancer of the C... Vulvar Cancer Esophageal Canc... Anal Canal Canc...	FDG PET scan	18 Years -	Duke University

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