Skip to main content
OpenTrials
Completed

NCT Number: NCT00593866

Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer

This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rush University Medical Center, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is the patient 18 years of age or older.
  • Does the patient have histologically or cytologically proven carcinoma of the pancreas
  • Is the tumor unresectable or medically inoperable
  • Does the patient have a Zubrod performance status of ≤ 2 (appendix I).
  • Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥ 100,000/mm3
  • Does the patient have adequate renal function (creatinine < 2 mg/dl) and hepatic function (bilirubin < 3 mg/dl), with relief of biliary obstruction if present
  • Is the patient free of significant co-morbid conditions that would preclude safe administration or completion of protocol therapy
  • If the patient is of reproductive potential, has he or she agreed to use an effective method of contraception during treatment on this trial and for 6 months after treatment
  • Is the patient aware of the investigational nature of the therapy such that they can provide written informed consent

Exclusion criteria

  • Does the patient have a neuroendocrine tumor of the pancreas
  • Does the patient have metastatic disease
  • Does the patient have a history of abdominal radiation therapy
  • Is there history of more than 1 month of therapy with single agent gemcitabine
  • Has the patient used any investigational agent in the month before enrollment into the study

Treatment and study plan

Intensity modulated radiotherapy

Radiation

Five fractions weekly, fraction size determined by dose level

Other names: Radiation dose escalation:, Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction), Level 1 45.0 1.8 53.1 45.0, Level 2 50.0 2.0 60.0 50.4, Level 3 52.5 2.1 63.5 54.0, Level 4 55.0 2.2 67.1 57.0, Level 5 57.5 2.3 70.7 60.0, Level 6 60.0 2.4 74.4 63.0, Level 7 62.5 2.5 78.1 66.2, Level 8 65.0 2.6 81.9 69.4, * BED=Biological Effective Dose; =10

Gemcitabine

Drug

1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment

Primary outcomes

  1. The Maximum Tolerated Radiation Dose

    Time frame: 13 weeks post radiation

    The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.

Secondary outcomes

  1. The Percentage of Participants Free From Local Progression at 2 Years

    Time frame: 2 Years

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Rush University Medical Center

Registry information

Official study title

A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer

Important dates

Study start
2006
Primary completion
2012
Study completion
2014
First posted
Jan 15, 2008
Registry last updated
Sep 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.