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Folfirinox

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FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours

FOLFIRINOX

Autumn J McRee, MD

This single arm, multi-center phase II clinical trial will assess the safety and efficacy of FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA) and borderline resectable (BR) pancreatic cancer.

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard in the treatment of metastatic pancreatic cancer for selected patients. With improved overall survival (OS) and response rates (RR) in the metastatic setting, we hypothesize that in patients with less tumor burden, this regimen will be safe and well tolerated, improve OS, progression free survival (PFS), and RR, and improve resectability rates, as compared to historical data from standard single agent gemcitabine therapy for unresectable locally advanced (ULA) patients and standard radiation with concurrent 5 fluorouracil (5FU) chemotherapy for borderline resectable (BR) patients. While both ULA and BR patients will be eligible for the present study, our primary objective concerns ULA patients, and we plan to enroll 45 patients in this group.

Patients meeting eligibility criteria will be consented and treated with FOLFIRINOX every 2 weeks (1 cycle = 4 weeks = 2 treatments). Patients will undergo repeat imaging (CT or MRI) every 2 cycles and reassessed for resectability of the tumor. All patients that are not able to undergo surgical resection, due to insufficient down-staging or patient preference, will continue on protocol-based therapy until disease progression, unacceptable toxicity, study withdrawal, or death.

FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer

Phase II Single Arm Clinical Trial of FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer

Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).

All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).

All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)

Progression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored

All patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically.

Disease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.

Rate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.

UNC Lineberger Comprehensive Cancer Center

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Robin V. Johnson

Patients with unresectable locally advanced pancreatic cancer.

Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer

Overall Survival for Borderline Resectable Patients

Progression Free Survival (PFS)

Objective Response Rate

Disease Control Rate (DCR)

Rate of Resectability (RR)

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours

Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).

Overall Study

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Diseases

Adnexal Diseases

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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Hormones

Retrospective analysis of all patients diagnosed, from 01/01/2000 to 01/01/2014, with low-grade serous ovarian cancer or invasive recurrence after surgery for borderline serous carcinoma

Francesco Perrone, MD PhD

Teresa Ribecco, PhD

Sandro Pignata, MD PhD

Chiara Della Pepa, MD

The purpose of this study is to retrospectively evaluate treatments and outcomes of patients with low grade serous ovarian carcinomas in Italy.

Archival tissue tumor samples in paraffin blocks for evaluation of diagnosis and biomarkers

Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer

National Cancer Institute, Naples

PANDAS

Gemcitabine

Capecitabine

Levoleucovorin

Folinic Acid

Neoadjuvant chemotherapy with mFolfirinox regimen + concomitant chemoradiotherapy + surgery + adjuvant chemotherapy

Neoadjuvant chemotherapy with mFolfirinox regimen + surgery + adjuvant chemotherapy

oxaliplatin folinic acid irinotecan 5FU oxaliplatin

mFolfirinox

conformational external irradiation (50.4 Gy) + capecitabine

Chemoradiotherapy

1 to 4 weeks after neoadjuvant treatment according to tumour response

surgery

Gemcitabine or modified LV5FU (folinic acid+-bolus fluorouracil+ infusional fluorouracil)

Adjuvant chemotherapy

Thierry CONROY, Pr

Jean-Baptiste BACHET, Pr

Pascal HAMMEL, Pr

This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.

Surgery, especially if followed by adjuvant chemotherapy, offers the only chance of cure of pancreatic cancer. At first diagnosis, after careful assessment, only 10 to 15% of patients are considered to be candidates for surgical resection and about 7% have a potentially resectable disease. These potentially resectable tumors called "borderline resectable pancreatic cancer" (BRPC) are conceptualized as those that involve the mesenteric vasculature to a limited extent and those for which resection, while possible, would likely be compromised by positive surgical margins (R1) in the absence of neoadjuvant treatment. R0 resection is indeed considered as an independent prognostic factor for survival when the surgical procedures, histological examination and definition of microscopic invasion are standardized.

The objectives of neoadjuvant treatments of BRPC is to reduce tumor volume before surgery in order to improve the chances of radical (R0) resection and to reduce the rate of lymph node positivity and recurrences. The primary outcome in published studies is usually R0 resection rate, but these results also depend on the number of margins examined and the definition of microscopic margin involvement. Prospective studies with consistent selection criteria and standardized assessment criteria are needed.

Different neoadjuvant therapeutic strategies have been tested in pilot studies: preoperative chemoradiotherapy or neoadjuvant chemotherapy, followed or not by a preoperative (chemo)radiotherapy. Due to the lack of randomized studies, the best sequence of treatment administration has not been established.

The aim of this prospective, randomized, multicenter, trial is to evaluate the R0 resection rate with neoadjuvant Folfirinox, followed or not by radiochemotherapy for patients with borderline resectable pancreatic cancers.

Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)

Two Arm, Prospective, Multicenter Randomized Phase II Trial of Neoadjuvant Modified Folfirinox Regimen, With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer	NCT01688336	Pancreatic Canc...	FOLFIRINOX	18 Years -	UNC Lineberger Comprehensive Cancer Center
Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer	NCT02408536	Low-grade Serou... Recurrent Invas...		18 Years -	National Cancer Institute, Naples
Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)	NCT02676349	Pancreatic Carc...	mFolfirinox Chemoradiothera... surgery Adjuvant chemot...	18 Years - 75 Years	Institut de Cancérologie de Lorraine
Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer	NCT02408536	Low-grade Serou... Recurrent Invas...		18 Years -	National Cancer Institute, Naples
Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)	NCT02676349	Pancreatic Carc...	mFolfirinox Chemoradiothera... surgery Adjuvant chemot...	18 Years - 75 Years	Institut de Cancérologie de Lorraine
FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer	NCT01688336	Pancreatic Canc...	FOLFIRINOX	18 Years -	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for borderline

Every month we try and update this database with for borderline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for borderline

Every month we try and update this database with for borderline cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for borderline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.