← Back to Search

Chemotherapy

Adaptive Neoadjuvant Chemotherapy for Pancreatic Cancer (PANC Trial)

Phase 2
Recruiting
Led By Kathleen Christians, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not required for the study.
Have adequate organ and bone marrow function as defined by: total leukocytes >3 x10^3/μL, absolute neutrophil count (ANC) >1.5x 10^3/μL, hemoglobin >9 g/dL, platelets >100 x 10^3/μL, creatinine clearance >60 mL/min or creatinine <1.5 mg/dL, bilirubin < 2 mg/dL, aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) <3 x upper limit of normal (ULN).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five years
Awards & highlights

PANC Trial Summary

This trial is testing a new treatment for people with pancreas cancer that has not spread.

Who is the study for?
Adults with confirmed pancreatic adenocarcinoma that's resectable or borderline so, who haven't had extensive prior treatments and are in fairly good health (ECOG <2). They must have certain blood and organ function levels, not be pregnant or breastfeeding, use contraception if of childbearing potential, and can't have HIV/HBV/HCV or other serious conditions.Check my eligibility
What is being tested?
This phase II trial is testing how well patients respond to different sequences of chemotherapy and chemoradiation before surgery. It's open-label, meaning everyone knows which treatment they're getting. The goal is to find the best approach for shrinking tumors pre-surgery.See study design
What are the potential side effects?
Chemotherapy and chemoradiation may cause nausea, vomiting, fatigue, hair loss, low blood cell counts leading to increased infection risk or bleeding problems. There might also be liver issues due to medication toxicity.

PANC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer diagnosis was confirmed through a biopsy.
Select...
My blood and organ tests meet the required levels for treatment.
Select...
I am either not able to have children, using birth control, or have a negative pregnancy test.
Select...
I can do most of my daily activities without help.
Select...
I am 18 years old or older.
Select...
My pancreatic cancer is at a stage where surgery might be possible.
Select...
My CA19-9 levels are high, but my bilirubin is low.

PANC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and five years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Completion of all intended neoadjuvant therapy and surgical therapy
Secondary outcome measures
Overall survival
Progression-free survival

Side effects data

From 2013 Phase 3 trial • 688 Patients • NCT00424255
63%
Mucosal inflammation
52%
Nausea
48%
Rash
44%
Vomiting
42%
Diarrhoea
42%
Dry mouth
36%
Dysphagia
26%
Weight decreased
25%
Lymphopenia
24%
Leukopenia
22%
Anaemia
20%
Neutropenia
18%
Pyrexia
18%
Decreased appetite
17%
Constipation
17%
Asthenia
16%
Radiation skin injury
14%
Stomatitis
13%
Cough
13%
Oropharyngeal pain
13%
Blood creatinine increased
12%
Odynophagia
12%
Skin reaction
12%
Fatigue
12%
Hypokalaemia
9%
Haemoglobin decreased
9%
Hyponatraemia
9%
White blood cell count decreased
9%
Dysgeusia
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Dyspepsia
8%
Creatinine renal clearance decreased
7%
Dysphonia
7%
Pruritus
7%
Productive cough
7%
Oral pain
7%
Thrombocytopenia
6%
Lymphocyte count decreased
6%
Headache
6%
Neck pain
5%
Oral candidiasis
5%
Insomnia
4%
Radiation mucositis
4%
Musculoskeletal pain
3%
Ejection fraction decreased
2%
Pneumonia
2%
Dehydration
1%
Oesophageal stenosis
1%
Epistaxis
1%
Hepatic enzyme increased
1%
Pharyngeal fistula
1%
Hyperkalaemia
1%
Acute respiratory failure
1%
Mouth haemorrhage
1%
Wound infection
1%
Febrile neutropenia
1%
General physical health deterioration
1%
Hyperuricaemia
1%
Malnutrition
1%
Hypocalcaemia
1%
Feeding disorder
1%
Sepsis
1%
Lung abscess
1%
Oral infection
1%
Blood uric acid increased
1%
Dyspnoea
1%
Pneumonia aspiration
1%
Tracheostomy malfunction
1%
Cerebral ischaemia
1%
Renal failure
1%
Renal impairment
1%
Hyperbilirubinaemia
1%
Depression
1%
Death
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Lapatinib 1500 mg

PANC Trial Design

3Treatment groups
Experimental Treatment
Group I: Restaging: Response to TreatmentExperimental Treatment1 Intervention
After the first restaging evaluation, further treatment will be based on treatment response. Patients who demonstrate a response [decline in carbohydrate antigen 19-9 (CA19-9) values] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months.
Group II: Restaging: Patients with Stable DiseaseExperimental Treatment1 Intervention
Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months.
Group III: Restaging: Local Disease ProgressionExperimental Treatment1 Intervention
After the first restaging evaluation, further treatment will be based on treatment response. If, at the initial restaging, the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemoradiation
2006
Completed Phase 3
~990

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,386 Total Patients Enrolled
Kathleen Christians, MDPrincipal InvestigatorProfessor
Susan Tsai, MD, MHSPrincipal Investigator - Associate Professor
Clement J. Zablocki VA Medical Center, Froedtert & The Medical College of Wisconsin
University Of Michigan Medical Sch (Medical School)
University Of Mi Hosps (Residency)
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

First-line Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03322995 — Phase 2
Pancreatic Cancer Research Study Groups: Restaging: Local Disease Progression, Restaging: Patients with Stable Disease, Restaging: Response to Treatment
Pancreatic Cancer Clinical Trial 2023: First-line Chemotherapy Highlights & Side Effects. Trial Name: NCT03322995 — Phase 2
First-line Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03322995 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned chemoradiation therapy?

"Chemoradiation's safety is rated 2, as the Phase 2 trial has only provided data demonstrating its security but not its effectiveness."

Answered by AI

Are there any vacancies for prospective participants in this experiment?

"Affirmative, clinicaltrials.gov data indicates that enrollment is ongoing for this medical trial. Initially posted on June 21st 2018 and updated most recently in July 29th 2022, the study seeks 125 patients from a single centre of research."

Answered by AI

Are there any analogous experiments involving the combination of chemotherapy and radiation therapy?

"Presently, there are 1013 Chemoradiation trials ongoing worldwide. Of those, 312 are in Phase 3. The greatest concentration of these studies is located in Guangzhou, Guangdong; however, the data indicates that 48793 different institutions have launched or will launch research into Chemoradiation therapy."

Answered by AI

How many participants are enrolled in this research?

"Absolutely. Data available from clinicaltrials.gov proves that this medical trial, which was first published on June 21st 2018, is actively recruiting participants. A total of 125 volunteers must be sourced from a single site for the study to continue as planned."

Answered by AI

To what ailments is Chemoradiation routinely recommended?

"Chemoradiation is a standard therapy for cases of non-small cell lung carcinoma, rectal carcinoma and colorectal carcinoma."

Answered by AI
~36 spots leftby Aug 2026