Chemotherapy for Pancreatic Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Strecker Cancer Center-Belpre, Belpre, OHPancreatic Cancer+8 MoreChemotherapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • 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

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 11 years

Month 24
Changes in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (primary) and the Patient-Reported Outcomes Measurement Information System derived short form (exploratory)
Year 11
Overall survival (Phase II)
Year 11
Overall survival (Phase III)
Up to 11 years
Disease-free survival
Frequency of objective criteria of resectability as measured by preoperative imaging
Incidence of adverse events assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (CTCAE version 5.0 will be used starting April 1, 2018)

Trial Safety

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

Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)Experimental Group · 4 Interventions: Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Erlotinib Hydrochloride, Quality-of-Life Assessment · Intervention Types: Drug, Other, Drug, Other
Arm III (chemotherapy)Experimental Group · 4 Interventions: Gemcitabine Hydrochloride, Chemotherapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment · Intervention Types: Drug, Drug, Other, Other
Arm IV (chemotherapy, chemoradiotherapy)Experimental Group · 8 Interventions: Gemcitabine Hydrochloride, Fluorouracil, Chemotherapy, Laboratory Biomarker Analysis, Intensity-Modulated Radiation Therapy, Quality-of-Life Assessment, 3-Dimensional Conformal Radiation Therapy, Capecitabine · Intervention Types: Drug, Drug, Drug, Other, Radiation, Other, Radiation, Drug
Arm I (gemcitabine hydrochloride or combination chemotherapy)ActiveComparator Group · 4 Interventions: Gemcitabine Hydrochloride, Chemotherapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment · Intervention Types: Drug, Drug, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Fluorouracil
FDA approved
Chemotherapy
2003
Completed Phase 4
~2740
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~1680
Erlotinib
FDA approved
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Capecitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 11 years

Who is running the clinical trial?

NRG OncologyOTHER
221 Previous Clinical Trials
95,315 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,167 Previous Clinical Trials
41,168,010 Total Patients Enrolled
Ross A AbramsPrincipal InvestigatorNRG Oncology

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.