Radiotherapy Combined With Oxaliplatin and Fluorouracil Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

Tracking Information
First Submitted Date ICMJE	November 9, 2004
First Posted Date ICMJE	November 9, 2004
Last Update Posted Date	July 16, 2013
Study Start Date ICMJE	December 2004
Actual Primary Completion Date	April 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 13, 2012)	1-year survival rate [ Time Frame: At 1 year ]; 1-year survival will be considered "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. If more than 1 patients is lost to follow-up, we will use Kaplan-Meier estimates for the 6-month and 12-month overall survival rates. 95% confidence intervals for the true success proportion will be calculated according the approach of Duffy and Santner.
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00096070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 13, 2012)	Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 3 years ]The distribution of survival time will be estimated using the method of Kaplan-Meier.; Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart [ Time Frame: Up to 6 months ]; Time to disease progression [ Time Frame: Time from registration to documentation of disease progression, assessed up to 3 years ]The distribution of time to progression will be estimated using the method of Kaplan-Meier.; Duration of response [ Time Frame: Date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years ]; Time to treatment failure [ Time Frame: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 3 years ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Radiotherapy Combined With Oxaliplatin and Fluorouracil Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer
Official Title ICMJE	Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer
Brief Summary	This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Oxaliplatin may also make the tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy may kill more tumor cells.
Detailed Description	PRIMARY OBJECTIVES: I. Determine the 1-year survival rate in patients with locally advanced, unresectable adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy, oxaliplatin, and fluorouracil followed by gemcitabine. SECONDARY OBJECTIVES: I. Determine overall survival, time to disease progression, and confirmed response rate in patients treated with this regimen. II. Determine toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Adenocarcinoma of the Pancreas; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer
Intervention ICMJE	Radiation: radiation therapy Undergo radiation therapy Other Names: irradiation radiotherapy therapy, radiation; Drug: oxaliplatin Given IV Other Names: 1-OHP Dacotin Dacplat Eloxatin L-OHP; Drug: fluorouracil Given IV Other Names: 5-fluorouracil 5-Fluracil 5-FU; Drug: gemcitabine hydrochloride Given IV Other Names: dFdC difluorodeoxycytidine hydrochloride gemcitabine Gemzar
Study Arms	Experimental: Arm I; Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.; Interventions: Radiation: radiation therapy; Drug: oxaliplatin; Drug: fluorouracil; Drug: gemcitabine hydrochloride
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 8, 2007)	50
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Actual Primary Completion Date	April 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the pancreas Unresectable disease, including subtotal resection and gross residual disease Locally advanced disease; No cystadenocarcinoma of the pancreas; No pancreatic tumors of neuroendocrine origin; No microscopic residual disease as only evidence of pancreatic cancer; All disease must be encompassable within standard radiotherapy fields for pancreatic cancer; No distant metastases (liver or lung metastases or peritoneal spread) No evidence of metastatic disease outside the planned radiotherapy field; Performance status - ECOG 0-1; Absolute neutrophil count ≥ 1,500/mm^3; Platelet count ≥ 100,000/mm^3; Hemoglobin ≥ 9.0 g/dL; Bilirubin ≤ 2 times upper limit of normal (ULN); AST ≤ 3 times ULN; Creatinine ≤ 1.5 times ULN; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; Able to maintain adequate oral nutrition; No significant infection; No significant nausea or vomiting; No other medical condition that would preclude study participation; No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score < 7); No known allergy to platinum compounds; No prior biologic therapy; No concurrent biologic therapy; No concurrent immunotherapy; No prior chemotherapy; No other concurrent chemotherapy; No prior radiotherapy that would overlap planned radiotherapy fields; No other concurrent radiotherapy; See Disease Characteristics; At least 21 days since prior laparotomy
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00096070
Other Study ID Numbers ICMJE	NCI-2012-01816; N0349; CDR0000391191; NCCTG-N0349; U10CA025224 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Cancer Institute (NCI)
Study Sponsor ICMJE	National Cancer Institute (NCI)
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: George Kim North Central Cancer Treatment Group
PRS Account	National Cancer Institute (NCI)
Verification Date	June 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP