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Anti-metabolites

Chemotherapy + Radiation for Pancreatic Cancer

Phase 2

Recruiting

Led By Naveenraj Solomon, MD

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cytologic or histologic proof of adenocarcinoma of the pancreas

Adequate hematologic, renal and hepatic function as defined by: ANC greater or equal to 1,500 cells/mm3, Platelets greater or equal to 100,000 cells/mm3, Serum bilirubin ≤ 1.5 x upper limit of normal (ULN), Serum creatinine ≤ 2 x ULN, ALT ≤ 5 x ULN, AST ≤ 5 x ULN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every six months up to 6 years post-resection.

Awards & highlights

Study Summary

This trial is testing whether adding chemotherapy and radiation to the standard of care for resectable pancreatic cancer can improve the chances of surgeons achieving an R0 resection.

Who is the study for?

This trial is for adults over 18 with confirmed pancreatic adenocarcinoma that hasn't been treated yet. They must have good blood, kidney, and liver function, no serious infections needing IV antibiotics, and tumors that can potentially be removed by surgery. Pregnant or breastfeeding individuals or those with recent other cancers are excluded.Check my eligibility

What is being tested?

The study tests if giving two FDA-approved chemotherapy drugs (gemcitabine and nab-paclitaxel) plus radiation therapy before surgery can improve the chances of completely removing pancreatic cancer. The main goal is to see if this approach leads to a high rate of complete tumor removal without any remaining cancer cells.See study design

What are the potential side effects?

Possible side effects include reactions from the chemotherapy like nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk or bleeding problems; as well as skin irritation or other issues related to radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis is pancreatic adenocarcinoma.

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My blood, kidney, and liver tests are within the required ranges.

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I am 18 years old or older.

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I haven't needed IV antibiotics for an infection when starting this study.

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I have never been treated for pancreatic cancer before.

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My tumor can possibly be removed with surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every six months up to 6 years post-resection.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every six months up to 6 years post-resection.

This trial's timeline: 3 weeks for screening, Varies for treatment, and every six months up to 6 years post-resection. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Curative Intent Resection (R0) rate

Secondary outcome measures

Disease Free Survival Rate

Overall Survival Rate

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

79%

Cough

64%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Chest pain

21%

Anorexia

21%

Lymphocyte count decreased

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Alopecia

Dehydration

Creatinine increased

Otitis externa

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Blurred vision

Tachycardia

Lung infection

Neuropathy

Hypertension

Pleuritic pain

Neutropenia

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy

Maintenance Chemotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemotherapy and SBRTExperimental Treatment3 Interventions

Pre-Operative Chemotherapy: Within 28 days of study enrollment, subjects will receive a combination of Gemcitabine and Nab-paclitaxel for a maximum of four 28-day cycles. Gemcitabine 1000 mg/m2 IV on Days 1,8,15. Nab-paclitaxel 125 mg/m2 on Days 1,8,15. Post-Operative Chemotherapy: Within 5-10 weeks after surgery, subjects will receive a combination of Gemcitabine and Nab-paclitaxel for a maximum of two 28-day cycles. Gemcitabine 1000 mg/m2 IV on Days 1,8,15. Nab-paclitaxel 125 mg/m2 on Days 1,8,15. Standard Stereotactic Body Radiation Therapy (SBRT) fractionation of 6 Gy per day will be used for all patients to a total dose of 30 Gy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

nab-paclitaxel

2008

Completed Phase 4

~1330

Gemcitabine 1000 mg

2017

Completed Phase 2

~30

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,958 Total Patients Enrolled

Naveenraj Solomon, MDPrincipal InvestigatorLoma Linda University Cancer Center

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03492671 — Phase 2

Pancreatic Adenocarcinoma Research Study Groups: Chemotherapy and SBRT

Pancreatic Adenocarcinoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT03492671 — Phase 2

Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03492671 — Phase 2

Frequently Asked Questions

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

Are volunteers still needed for this experiment?

"That is correct, the online information hosted on clinicaltrials.gov affirms that this trial is currently looking for participants. This specific study was originally posted on July 17th, 2019 and has had recent activity on June 14th, 2022. Out of the 30 total spots available, 1 site still needs patients."

Answered by AI

What cancerous growths does Stereotactic Body Radiation Therapy help to eliminate?

"Stereotactic Body Radiation Therapy can offer patients with neoplasm metastasis, locally advanced non-small cell lung cancer, and metastatic bladder cancer a chance at treatment."

Answered by AI

What is the total number of patients that are participating in this clinical trial?

"Yes. The clinicaltrials.gov website has updated information that this trial is still looking for patients. This particular study was first posted on 7/17/2019, with the most recent changes made on 6/14/2022. They are enrolling 30 participants from 1 site."

Answered by AI

What is the history of research using Stereotactic Body Radiation Therapy?

"Currently, there are 1164 active clinical trials for Stereotactic Body Radiation Therapy (SBRT), with 330 of those trials in Phase 3. While several of the SBRT clinical trials are located in Shanghai, there are a total of 59839 locations running SBRT trials worldwide."

Answered by AI

Has Stereotactic Body Radiation Therapy undergone FDA approval process?

"While Phase 2 trials don't have the same level of data supporting efficacy, our team at Power has evaluated the available safety data and given Stereotactic Body Radiation Therapy a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer

2019. "Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03492671.

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