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Anti-metabolites

Gemcitabine/Nab-paclitaxel + Radiation Therapy + Surgical Resection for Pancreatic Cancer

Phase 1 & 2
Waitlist Available
Led By Neesha Dhani, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior resection
Acceptable length of vessel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs and radiation therapy to treat pancreatic cancer.

Who is the study for?
This trial is for under-70s with advanced pancreatic cancer affecting one major artery, but no metastases or aortic involvement. Candidates must be fit for surgery, not pregnant, agree to contraception use, and have good organ function. Exclusions include HIV/HBV/HCV infection, certain heart diseases, recent major surgery or chemo/radiotherapy to the pancreas within a year.Check my eligibility
What is being tested?
The study tests gemcitabine/nab-paclitaxel with radiation therapy before and after surgical removal of the tumor in patients with advanced pancreatic cancer. It aims to determine safety (phase 1) and effectiveness (phase 2) of this combined treatment approach.See study design
What are the potential side effects?
Potential side effects may include reactions from chemotherapy like nausea, fatigue, blood cell count changes leading to increased infection risk; radiation therapy might cause skin irritation or gastrointestinal symptoms; surgery carries risks such as bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have not had surgery to remove the tumor before.
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The vessel needs to be a certain length to be suitable.
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The tumor can be removed with surgery according to current medical guidelines.
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You are younger than 70 years old.
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You are able to perform daily activities without help or needing to rest most of the time.
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You have pancreatic cancer.
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Your bone marrow and organs must be working well.
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You can use heparin for medical treatment.
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There are no signs of the cancer spreading to other parts of the body.
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Your artery problem involves only one big blood vessel and can be surgically removed.
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It is possible to completely remove the tumor during surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Type and the severity of side effects
Secondary outcome measures
Average length of hospital stay per patient
Number of patients that are able to receive surgery after chemoradiation
Number of patients who disease has not progressed
+5 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gemcitabine/Nab-paclitaxel, Radiation and SurgeryExperimental Treatment4 Interventions
Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles. Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles. Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction) Surgery: Tumor resection and arterial resection/reconstruction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Surgical Resection
2018
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,769 Total Patients Enrolled
Neesha Dhani, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02481635 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT02481635 — Phase 1 & 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02481635 — Phase 1 & 2

Frequently Asked Questions

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

Does this clinical research currently need new participants?

"This medical trial is no longer accepting patients. It was initially posted in July 2016 and had its last update on April 2021. If you are seeking alternative studies, there are 697 trials recruiting for malignant neoplasm of pancreas and 1112 clinical tests admitting participants that use Gemcitabine as an intervention."

Answered by AI

How many individuals have enrolled in the trial to date?

"Unfortunately, this clinical trial is not presently admitting patients. Its first listing was July 1st 2016 with the last edit on April 14th 2021. Thankfully, for those seeking alternative studies there are 697 malignant neoplasm of pancreas and 1112 Gemcitabine trials actively enrolling participants at present."

Answered by AI

Are there any extant studies exploring the efficacy of Gemcitabine?

"Currently, 1112 experiments are being conducted to investigate gemcitabine. Out of those trials, 321 have reached phase 3 and thus far the most common location for these studies is Shanghai however there are 59388 sites running tests on this medication."

Answered by AI

Is the age requirement for participation in this clinical trial higher than 40 years old?

"As per the study guidelines, participants must be at least 18 years of age and no older than 70."

Answered by AI

For which conditions is Gemcitabine a recommended treatment option?

"For the purpose of managing neoplasm metastasis, Gemcitabine is a common choice. This medication has also proven to be effective for locally advanced non-small cell lung cancer, metastatic bladder cancer, and urinary bladder issues."

Answered by AI

Is my profile compatible with the qualifications for joining this research endeavor?

"This research endeavour is seeking 30 individuals aged 18-70 with a malignant neoplasm of the pancreas. Other conditions that must be met include no prior resection, absence of metastases, ability to obtain tumour free margins, acceptable vessel length, mass considered operable according to current standards, less than 70 years old and performance status <=2."

Answered by AI
~1 spots leftby Jun 2024