A Randomized Phase II/Genomic Trial of Two Chemotherapy R... | NCT01839799

NCT01839799

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1 - FOLFIRINOX	Experimental	FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles over 8 weeks Chemoradiation: Radiation to begin no sooner than 28 days from last day of chemotherapy. On Day 1(+ 2days to accommodate scheduling difficulties): Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined. FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated	Drug: FOLFIRINOX Radiation: Chemoradiation
Arm 2 - Gemcitabine / Abraxane	Experimental	Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles over 8 weeks Chemoradiation: Radiation to begin no sooner than 28 days from last day of chemotherapy. On Day 1 (+ 2days to accommodate scheduling difficulties) Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined. Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles, if tolerated	Drug: Gemcitabine Drug: Abraxane Radiation: Chemoradiation

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine	Drug	1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15	Arm 2 - Gemcitabine / Abraxane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Relapse-free Survival	In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study.	20 months

Eligibility Module

Name	Affiliation	Role
Peter O'Dwyer, MD	Abramson Cancer Center at Penn Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

Arm/Group Information

ID	Title	Description
FG000	FOLFIRINOX	FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated Chemoradiation
FG001	Gemcitabine/Abraxane	Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15 Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15 Chemoradiation

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	FOLFIRINOX	FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated Chemoradiation
BG001	Gemcitabine

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Relapse-free Survival

In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study.

Posted

Count of Participants

Participants

20 months

ID	Title	Description
OG000	Arm 1	FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated Chemoradiation
OG001	Arm 2	Gemcitabine: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15 Abraxane: 125 mg/m2 IV over 30 minutes, day 1, 8, 15 Chemoradiation

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm 1	FOLFIRINOX: Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated Chemoradiation

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Viral Syndrome	Infections and infestations		Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
nausea	Gastrointestinal disorders		Systematic Assessment

Title	Organization	Phone	Extension	Email
Jennifer Louie, Program Manager	University of Pennsylvania	215-220-9668		Jennifer.Louie2@pennmedicine.upenn.edu

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Mar 10, 2016	Apr 29, 2020	ICF_000.pdf
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 18, 2016	Apr 29, 2020	Prot_SAP_001.pdf

Intervention Browse Module

ID	Term
D000093542	Gemcitabine
D000068196	Albumin-Bound Paclitaxel
D017239	Paclitaxel
C000627770	folfirinox
D059248	Chemoradiotherapy

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides