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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathology: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma
TNM Stage: Tx-4, N0-1, M0 (M0 disease does not include spread to distant lymph nodes and organs)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Uptime between randomization and death from any cause, assessed up to 6 years.
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Study Summary
This trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery.
Eligible Conditions
- Pancreatic Cancer
- Pancreatic Carcinoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time between randomization and death from any cause, assessed up to 6 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time between randomization and death from any cause, assessed up to 6 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival
Disease-free survival (DFS)
Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received
+12 moreSide effects data
From 2016 Phase 2 trial • 60 Patients • NCT0009622693%
Fatigue
81%
Dyspnea
72%
Cough
67%
Hemoglobin
65%
Leukopenia NOS
61%
Nausea
60%
Anorexia
60%
Hyperglycemia NOS
58%
Dysphagia
56%
Esophagitis NOS
53%
Dermatitis radiation NOS
49%
Peripheral sensory neuropathy
46%
Weight decreased
44%
Constipation
44%
Alopecia
39%
Neutrophil count
35%
Pneumonitis NOS
33%
Chest pain
32%
Skin hyperpigmentation
30%
Platelet count decreased
30%
Chest wall pain
28%
Hypoalbuminemia
26%
Hyponatremia
25%
Pleural effusion
25%
Diarrhea NOS
25%
Lymphopenia
23%
Dyspepsia
23%
Vomiting NOS
21%
Aspartate aminotransferase increased
21%
Arthralgia
21%
Insomnia
19%
Sinus tachycardia
19%
Alanine aminotransferase increased
19%
Dehydration
19%
Hypocalcemia
19%
Myalgia
19%
Pain - Other
18%
Pneumothorax NOS
18%
Atelectasis
18%
Pericardial effusion
18%
Supraventricular arrhythmia NOS
18%
Hypokalemia
18%
Pyrexia
18%
Esophageal pain
16%
Blood alkaline phosphatase increased
16%
Hyperkalemia
16%
Dysgeusia
14%
Pharyngolaryngeal pain
14%
Hypomagnesemia
14%
Back pain
14%
Dizziness
14%
Headache
14%
Pruritus
12%
Blood/bone marrow - Other
12%
Pulmonary fibrosis
12%
Dry skin
12%
Sweating increased
12%
Hypersensitivity NOS
11%
Hypoxia
11%
Laryngitis NOS
11%
Radiation recall syndrome
11%
Metabolic/laboratory - Other
11%
Pain in extremity
11%
Dermatitis exfoliative NOS
11%
Depression
11%
Hypotension NOS
9%
Pulmonary/upper respiratory - Other
9%
Blood bilirubin increased
9%
Dry mouth
9%
Stomatitis
9%
Blood creatinine increased
9%
Anxiety
9%
Dermatology/skin - Other
9%
Thrombosis
7%
Hot flushes NOS
7%
Bronchospasm
7%
Edema: limb
7%
Hypermagnesemia
7%
Bone pain
7%
Pollakiuria
7%
Rigors
5%
Rhinitis allergic NOS
5%
Prolonged chest tube drainage or air leak after pulmonary resection
5%
Epistaxis
5%
Vision blurred
5%
Gastritis NOS
5%
Mucositis/stomatitis (functional/symptomatic): Esophagus
5%
Blood bicarbonate decreased
5%
Hypercalcemia
5%
Hypophosphatemia
5%
Ataxia
5%
Muscle weakness NOS
5%
Peripheral motor neuropathy
5%
Confusional state
2%
Ileus paralytic
2%
Arrhythmia NOS
2%
Myocardial ischemia
2%
Ocular/visual - Other
2%
Abdominal distention
2%
Colonic obstruction
2%
Serum sickness
2%
Anal infection NOS
2%
Gingival infection
2%
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
2%
Erythema multiforme
2%
Syncope
2%
Urinary retention
2%
Acute respiratory distress syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemoradiation, Surgery, Chemotherapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (perioperative chemotherapy, surgery)Experimental Treatment6 Interventions
Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-8 weeks of completing neoadjuvant chemotherapy, patients undergo surgical resection. Patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (surgery, adjuvant chemotherapy)Active Control6 Interventions
Patients undergo surgical resection. Beginning 3-12 weeks after surgery, patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Oxaliplatin
2011
Completed Phase 4
~1990
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin Calcium
2011
Completed Phase 3
~12290
Resection
2021
Completed Phase 2
~410
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
510 Previous Clinical Trials
217,883 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,487 Previous Clinical Trials
41,266,400 Total Patients Enrolled
Cristina R. Ferrone, MDStudy ChairMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Arm I (perioperative chemotherapy, surgery)
- Group 2: Arm II (surgery, adjuvant chemotherapy)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What do other researchers say about the benefits of Resection?
"At the moment, there are 677 ongoing clinical trials studying Resection. Out of these, 207 studies have progressed to Phase 3. The majority of these trials originate in Guangzhou, Guangdong; however, there are a total of 28743 locations running clinical trials for Resection."
Answered by AI
How many total people are enrolled in this research project?
"In order to properly run this trial, 352 individuals who match the pre-specified inclusion criteria are needed. These people can be recruited from various locations, such as Memorial Sloan Kettering Nassau in Uniondale, New York and Sanford Roger Maris Cancer Center in Fargo, North Dakota, New York and Sanford Roger Maris Cancer Center in Fargo, North Dakota."
Answered by AI
How many different medical clinics are conducting this study?
"This clinical trial has 34 recruiting sites, including Memorial Sloan Kettering Nassau in Uniondale, Sanford Roger Maris Cancer Center in Fargo, and Wayne State University/Karmanos Cancer Institute in Detroit."
Answered by AI
What maladies does Resection usually alleviate?
"Rectal carcinoma can usually be treated effectively through surgery (resection). This same surgical procedure can also help treat other conditions including colorectal carcinoma, ovarian cancer, and sarcoma."
Answered by AI
Are there any available positions for volunteers in this research project?
"Yes, the trial is ongoing and has 352 patients as its goal. The listing on clinicaltrials.gov says that the study was first posted on 7/1/2020, with the most recent update being 8/1/2022. There are 34 locations recruiting patients for this study."
Answered by AI
What are some of the risks associated with Resection?
"Resection is considered safe by our team, who gave it a score of 3. This is due to Phase 3 trials, where there is some data affirming the efficacy of Resection as well as multiple rounds of data supporting its safety."
Answered by AI
Who else is applying?
What site did they apply to?
Thomas Jefferson University Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
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