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Adenocarcinoma

Carcinoma

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Neoplasms by Histologic Type

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Oxaliplatin

Leucovorin

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Irinotecan

Folfirinox

Topoisomerase I Inhibitors

Enzyme Inhibitors

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Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

FOLFIRINOX consists of the following combination of drugs:

1. Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle
2. Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle
3. Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle
4. 5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.
5. 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.

FOLFIRINOX consists of the following combination of drugs:

1. Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle
2. Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle
3. Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4.5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.

5.5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.

FOLFIRINOX

Michael House, M.D.

The primary objective of this study is to evaluate the rate of pathologic complete response to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue collection component.

A Phase II Study of Neoadjuvant FOLFIRINOX

A Phase II Study of Neoadjuvant FOLFIRINOX in Patients With Resectable Pancreatic Ductal Adenocarcinoma With Tissue Collection

Pathologic complete response was evaluated using MRI or CT and Evan's criteria for pathologic response following neoadjuvant therapy:

I: \<10% to no tumor cells destroyed IIa: 10-50% of tumor cells destroyed IIb: 50-90% of tumor cells destroyed III: \>90% of tumor cells destroyed IIIM: sizable pools of cellular mucin IV: No viable tumor cells (complete pathologic response) IVM: Acellular pools of mucin

Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event with grade 3 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

The percentage of patients who successfully underwent surgery after neoadjuvant FOLFIRINOX and its 95% confidence interval will be provided.

The percentage of patients with a final margin status of R0 after resection of their primary tumor and its 95% confidence interval will be provided. R0 resection indicates a microscopically margin-negative resection, in which no cancer cells seen microscopically at the primary tumor site.

Disease free survival is defined as the time from on study date to evidence of tumor recurrence or death from any cause. Patients who remained alive and disease free were censored at their date of last disease evaluation.

Overall survival was defined as the time from on study date to death due to any cause. Patients who remained alive were censored at their last known alive date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.

Measured by RECIST v1.1 Complete response: Disappearance of all target lesions Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter

The percentage of patients with objective response and its 95% confidence interval will be provided.

Measured by RECIST v1.1

Complete response: Disappearance of all target lesions Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Stable disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started

The percentage of patients with objective response and its 95% confidence interval will be provided.

Indiana University

Assistant Professor of Clinical Medicine

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Amikar Sehdev

All patients who received at least two doses of FOLFIRINOX (unless treatment-related toxicity precluded additional doses) and had at least one post-baseline assessment or died before any evaluation.

Percentage of Patients With Pathologic Complete Response

All patients who received at least one dose of FOLFIRINOX.

Number of Patients With Treatment-Related Adverse Events Grade 3 or Above

Percentage of Patients Who Successfully Underwent Surgery After Neoadjuvant FOLFIRINOX

Rate of R0 Resection

Disease Free Survival

Overall Survival

Patients who received four treatments of FOLFIRINOX and had at least one post-baseline assessment.

Spots Global Cancer Trial Database for A Phase II Study of Neoadjuvant FOLFIRINOX

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