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Compares treatment options for Pancreas Cancer
Official title Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer
ClinicalTrials.gov ID: NCT07081360
What this study is testing
What is Neoadjuvant chemotherapy?
Neoadjuvant chemotherapy is an investigational medicine, being studied as a potential treatment for pancreas cancer.
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
- Adjuvant chemotherapy after surgery significantly improved the survival of pancreatic cancer (PC) patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesions which are not being detected in early disease status and improve the R0 resection rate.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma(endoscopic ultrasound (EUS)-guided biopsy).
- Clearly resectable disease as defined by National Comprehensive Cancer Network (NCCN) criteria on cross-sectional imaging: No involvement or abutment...
- Eastern Cooperative Oncology Group (ECOG)=0-1 \& American Society of Anesthesiologists (ASA) score \<4.
- Written informed consent.
- Medical history without previous pancreatic resection or pancreatic cancer.
You likely can't join if
- Borderline resectable or locally advanced pancreatic or periampullary cancer.
- Tumor at the body or tail of the pancreas.
- Distant metastases.
- Prior chemotherapy , surgery or radiotherapy for pancreatic cancer.
- Severe comorbidities precluding surgery or chemotherapy.
- Pregnancy or lactation.
See the full eligibility criteria
- Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma(endoscopic ultrasound (EUS)-guided biopsy).
- Clearly resectable disease as defined by National Comprehensive Cancer Network (NCCN) criteria on cross-sectional imaging: No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric...
- Eastern Cooperative Oncology Group (ECOG)=0-1 \& American Society of Anesthesiologists (ASA) score \<4.
- Written informed consent.
- Medical history without previous pancreatic resection or pancreatic cancer.
- Adequate organ function (liver, kidney, bone marrow) (serum creatinine ≤2.0 mg/dL,reference range 0.5-1.20 mg/dL; serum albumin ≥2.5 g/dL, reference range 3.5-5.3; aspartate aminotransferase (AST) ≤95 U/L, reference...
- Borderline resectable or locally advanced pancreatic or periampullary cancer.
- Tumor at the body or tail of the pancreas.
- Distant metastases.
- Prior chemotherapy , surgery or radiotherapy for pancreatic cancer.
- Severe comorbidities precluding surgery or chemotherapy.
- Pregnancy or lactation.
- Other neoplastic diseases (malignant)diagnosed in the past 5 years.
- Major surgery or traumatic event in the past 28 days.
The study team makes the final eligibility decision.
Where it's taking place
- Minya, Minya Governorate, Egypt
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minya, Minya Governorate, Egypt. 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.