CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 262 target
Drug / intervention
Neoadjuvant chemotherapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07081360
NCT07081360Phase 3RecruitingOn TrackUpdated 10mo ago

Neoadjuvant Chemotherapy Followed by Surgery Versus Upfront Surgery for Clearly Resectable Pancreatic Head Cancer and Periampullary Cancer: A Randomized Controlled Trial

Minia University·interventional·Posted Jul 23, 2025·Updated Aug 29, 2025

In Brief

A Phase 3 clinical trial evaluating Neoadjuvant chemotherapy and Upfront Surgery Group for Pancreas Cancer and 5 related conditions. Currently recruiting, targeting 262 participants across 1 site.

Detailed Summary

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. In addition, it prevents futile surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. There are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and periampullary cancer and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC and periampullary Cancer. This randomized controlled trial compares neoadjuvant chemotherapy followed by surgery versus upfront surgery for patients with clearly resectable pancreatic head cancer and periampullary cancer. The study aims to determine if neoadjuvant chemotherapy improves overall survival compared to immediate surgery followed by adjuvant chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 3Recruiting
202620272028
First PostedJul 23, 2025
Enrollment StartJul 20, 2025
Primary CompletionJul 20, 2028
Study CompletionAug 20, 2028
TodayJul 1, 2026
Enrollment to primary: 3 yearsPosted 11 months agoPrimary completion in 2.1 years

Interventions

Neoadjuvant chemotherapydrug

Neoadjuvant chemotherapy (mFOLFIRINOX) followed by pancreaticoduodenectomy

Upfront Surgery Groupprocedure

Pancreaticoduodenectomy followed by adjuvant chemotherapy