Study Summary
This trial is studying gemcitabine hydrochloride given with or without erlotinib hydrochloride, followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil, to see how well it works in treating patients with pancreatic cancer that has been removed by surgery.
- Stage IA Pancreatic Cancer
- Stage IIB Pancreatic Cancer
- Pancreatic Cancer
- Pancreatic Intraductal Papillary Mucinous Neoplasm
- Stage I Pancreatic Cancer
- Stage II Pancreatic Cancer
- Stage IIA Pancreatic Cancer
- Stage IB Pancreatic Cancer
- Pancreatic Acinar Cell Carcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: Up to 11 years
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Arm I (gemcitabine hydrochloride or combination chemotherapy)
1 of 4
Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
1 of 4
Arm III (chemotherapy)
1 of 4
Arm IV (chemotherapy, chemoradiotherapy)
1 of 4
Active Control
Experimental Treatment
545 Total Participants · 4 Treatment Groups
Primary Treatment: Chemotherapy · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Batukbhai, Bhavina, Joseph M. Herman, Marianna Zahurak, Daniel A. Laheru, Dung T. Le, Christopher Lee Wolfgang, Lei Zheng, and Ana De Jesus-Acosta. 2021. “Survival Outcomes of Adjuvant Chemotherapy Combined with Radiation Versus Chemotherapy Alone After Pancreatectomy for Distal Pancreatic Adenocarcinoma”. Pancreas. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpa.0000000000001724.
- 2009. "Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01013649.
Frequently Asked Questions
What are some of the short- and long-term risks associated with Chemotherapy?
"Chemotherapy was given a safety rating of 3 by our analysts at Power. This is because Phase 3 trials have shown some efficacy and there is a wealth of safety data available." - Anonymous Online Contributor
What are the most common purposes of Chemotherapy?
"Chemotherapy is most often used to treat actinic keratosis, but can also be useful in the treatment of colorectal carcinoma, malignant neoplasm of pancreas, and duke's c colon cancer." - Anonymous Online Contributor
Has Chemotherapy been looked at in other research projects?
"There are currently 1064 clinical trials underway that are studying chemotherapy. Of those, 330 are in Phase 3. Although many of the trials for chemotherapy are based in Guangzhou, Guangdong, there are 49933 locations running studies for this treatment." - Anonymous Online Contributor
Are there still open slots for new participants in this experiment?
"This particular study has completed recruitment for patients and is no longer enrolling. The study began on November 17th, 2009 and was last updated on September 23rd, 2022. For patients searching for other opportunities, there are 1,304 trials actively enrolling patients with pancreatic carcinoma and 1,064 studies for Chemotherapy actively enrolling patients." - Anonymous Online Contributor