Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

Paclitaxel

Albumin-Bound Paclitaxel

Pancrelipase

Pancreatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Chemotherapy:

Gemcitabine 1000 mg/m2 and Abraxane 125 mg/m2 weekly x3 of 28 day cycle

Radiation:

20-55 GY over 5 fractions

Dosing schedule: 3 cycles of chemotherapy, followed by CyberKnife, followed by 3 additional cycles of chemotherapy.

nab-paclitaxel

CyberKnife

This study is looking at determining the maximum safe dose of CyberKnife when given with chemotherapy for unresectable adenocarcinoma of the pancreas.

The purpose of this study is to determine the MTD for radiosurgery in the treatment of unresectable pancreas cancer, this MTD can then be used in future phase II or III studies. In terms of starting dose for the phase I study, based on the low toxicity seen in the Moffitt study we feel that 30 Gy in five fractions will be a successful starting dose.

Most of the data in unresectable is derived from patients in the metastatic setting in terms of chemotherapy agents. There have been two major studies that looked at various chemotherapy regimens versus the previous standard of care Gemzar. One study found improved survival with FOLFIRINOX and a second found that the combination of nab-paclitaxel and gemzar were superior to gemzar alone. Thus, the current standard of care for metastatic pancreas cancer (in which a local therapy like radiation has more limited role) is either FOLFIRINOX or gemzar and nab-paclitaxel. While there is some discussion of a randomized study comparing FOLFIRINOX and gemzar combined with nab-paclitaxel such a study has not started as of this time and it is unclear how much interest there would be in accruing to this study. Therefore the exact best chemotherapy regimen for metastatic disease is unclear but is either FOLFIRIONX or gemzar-nab-paclitaxel. The chemotherapy regimens for unresectable cancer are extrapolated from the metastatic setting, per NCCN guidelines any chemotherapy regimen approved for metastatic disease is reasonable to use in unresectable pancreas cancer. Thus for purpose of this study we have chosen one of the two chemotherapy regimens that have shown the best results in the metastatic setting, since there is no way to determine the exact best regimen we have chosen gemzar and nab-paclitaxel since it is felt that this is a less toxic regimen as compared to FOLFIRINOX.

Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002)

Phase I Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002)

This study is to evaluate the MTD for Cyberknife when given in conjunction with Gemcitabine and Abraxane.

The Cooper Health System

Chemotherapy:

Gemcitabine 1000 mg/m2 weekly x 3 on 28 day cycle

Radiation:

25 Gy over 5 fractions

Surgery:

surgical resection of pancreas

treatment plan:

1 cycle of chemotherapy, followed by stereotactic radiosurgery, followed by an additional 6 cycles of chemotherapy or surgical resection

Stereotactic Radiosurgery

Kimberly Krieger

Kim Krieger

This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the treatment of potentially resectable adenocarcinoma of the pancreas

This study is evaluating the role of neoadjuvant chemotherapy and CyberKnife therapy in increasing the number of patients who are able to successfully undergo definitive surgical management of their pancreatic carcinoma. In addition, we will evaluate the associated therapeutic toxicities and gather data regarding the quality of life indicators at similar time intervals for an improved overall assessment of the effects of this course of treatment on our patients.

Surgery is deemed the only curative technique for pancreatic cancer. Unfortunately, more than 80% of patients who present with the disease cannot be cured by resection.

The literature reports median survival for resectable patients on the order of 19 months, with a 20% 5 year survival rate. For patients unable to undergo surgical resection, the median survival in the literature is approximately 11 months. In the absence of the proposed protocol, this patient population would be treated as per the standard of care for locally advanced non-metastatic surgically unresectable pancreatic malignancies, which would include a combination of chemotherapy and radiation therapy. The anticipated Grade 4 and above toxicity would be approximately 3-5% from this regimen. The rate of G 4 and above toxicity is not known with the use of this neoadjuvant regimen, and, therefore, this constitutes the major risk associated with this protocol therapy. The associated benefit, however, is the anticipated improvement in median survival that these patients may derive from the ability to successfully undergo surgical resection. A secondary proposed benefit is the potential for reduction in the treatment associated toxicity with this altered multimodality schedule when compared to traditional multimodality care or non-surgical care of locally advanced pancreatic malignancy.

A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer

Evaluate the percentage of subjects who successfully undergo pancreaticoduodenectomy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002)	NCT02707328	Pancreas Cancer Pancreatic Canc... Adenocarcinoma ... Pancreas Adenoc... Pancreatic Aden...	Gemcitabine nab-paclitaxel CyberKnife	18 Years -	The Cooper Health System
Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002)	NCT02707328	Pancreas Cancer Pancreatic Canc... Adenocarcinoma ... Pancreas Adenoc... Pancreatic Aden...	Gemcitabine nab-paclitaxel CyberKnife	18 Years -	The Cooper Health System
A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer	NCT02707315	Pancreas Cancer Pancreatic Canc... Adenocarcinoma ... Pancreas Adenoc... Pancreatic Aden...	Gemcitabine Stereotactic Ra...	18 Years -	The Cooper Health System
A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer	NCT02707315	Pancreas Cancer Pancreatic Canc... Adenocarcinoma ... Pancreas Adenoc... Pancreatic Aden...	Gemcitabine Stereotactic Ra...	18 Years -	The Cooper Health System

Spots Global Cancer Trial Database for cyber knife

Every month we try and update this database with for cyber knife cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cyber knife

Every month we try and update this database with for cyber knife cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cyber knife cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.