Clinical trialPhase 1 / Phase 2Completed
Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer
A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- June 2006
- Expected end
- October 2014
- Enrollment
- 50 participants
- Sites
- 2
- Primary outcomes
- The Maximum Tolerated Radiation Dose
- Sponsor
- Other
- Results posted
- 2014-08-27
- Last update
- 11 September 2015
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
The Maximum Tolerated Radiation Dose [13 weeks post radiation]. Number, Gray (Gy). Radiation Dose Escalation With Gemcitabine (n=50): 55.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
The Percentage of Participants Free From Local Progression at 2 Years [2 Years]. Number, percentage of participants (95% Confidence Interval). Radiation Dose Escalation With Gemcitabine (n=50): 59 (32 to 79).