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New treatment option for Pancreas Adenocarcinoma
Official title Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer
ClinicalTrials.gov ID: NCT03492671
What this study is testing
What is Gemcitabine 1000 mg?
Gemcitabine 1000 mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreas adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (all criteria must apply):
- 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.
You likely can't join if
- 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...
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
See the full eligibility criteria
- (all criteria must apply):
- 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.
- 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
- No history of prior therapy for pancreatic cancer.
- No history of active infection requiring IV antibiotics at the start of study treatment
- Non-pregnant and non-breast-feeding.
- 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...
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.