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

ConditionsPancreas AdenocarcinomaResectable Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoma Linda University

About this trial

The purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational portion of this study is providing the chemotherapy drugs and radiation therapy before surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cytologic or histologic proof of adenocarcinoma of the pancreas.

Localized, potentially resectable tumors.

Greater or equal to 18 years of age.

ECOG performance status of 0 or 1.

Disqualifiers

Patient has borderline resectable or metastatic disease.

History of malignancy in the last 5 years other than in situ cancer or basal or squamous cell skin cancer or malignancies cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.

Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Gemcitabine 1000 mg

    Drug

    Pre-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)

  • nab-paclitaxel

    Drug

    Pre-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)

  • Stereotactic Body Radiation Therapy

    Radiation

    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 groups

30 Participants
are divided into 1 treatment group
Group A: Chemotherapy and SBRTExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Curative Intent Resection (R0) rate

Measure the rate of R0 resection with all margins microscopically clear.

Time frame
Within 2 weeks prior to initiation of post-operative chemotherapy.

Secondary outcomes

1

Disease Free Survival Rate

Subject will be followed post-resection for evidence of pancreatic cancer.

Time frame
Every three months up to two years after resection.
2

Overall Survival Rate

Subject will be followed post-resection for overall survival rate.

Time frame
Every six months up to 6 years post-resection.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loma Linda University

Lead sponsor

Source ClinicalTrials.gov
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