RecruitingPhase 3NCT06427447
Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)
Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer
Sponsor
Changhai Hospital
Enrollment
770 participants
Start Date
Aug 6, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
In this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria7
- Aged 18-75 years
- Pathologically confirmed pancreatic ductal adenocarcinoma
- Pathologically confirmed lymph node metastasis, R1 or R2 resection or lymphovascular invasion (one of the risk factors)
- No history of cancer treatment after surgical resection
- No disease progression confirmed by imaging examinations
- ECOG 0 to1 point
- No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2)
Exclusion Criteria10
- History of cancer treatment after surgical resection
- History of other cancers within 5 years
- Disease progression, including local pprogression or metastasis, confirmed by imaging examinations
- ECOG ≥2 points
- Significant abnormality in blood routine test, liver and kidney function test and coagulation test
- Active inflammatory bowel disease
- Gastrointestinal bleeding or perforation within 6 months
- Infections requiring antibiotics
- Heart or respirotory insufficiency
- Pregnant women or breastfeeding women
Interventions
COMBINATION_PRODUCTAdjuvant chemoradiotherapy
Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine)
DRUGAdjuvant chemotherapy
Chemotherapy (gemcitabine plus capecitabine)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06427447
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