Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)
ADJUPANC
1 other identifier
interventional
770
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pancreatic-cancer
Started Aug 2024
Typical duration for phase_3 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2024
CompletedFirst Posted
Study publicly available on registry
May 23, 2024
CompletedStudy Start
First participant enrolled
August 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
February 4, 2025
May 1, 2024
3.9 years
May 19, 2024
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease progression free survival will be determined.
The time from the start of treatment until documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
3 years
Secondary Outcomes (3)
Overall survival will be determined.
3 years
Treatment-related adverse events will be determined.
3 years
Quality of life will be determined.
3 years
Study Arms (2)
adjuvant chemoradiotherapy
EXPERIMENTALChemotherapy: Gemcitabine plus capecitabine Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 1650-2000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered. Chemoradiotherapy: 2-3 weeks after chemotherapy, adjuvant chemoradiotherapy is given. Radiation dose: 50-54Gy (1.8-2.0Gy per fraction). Concurrent capecitabine, 1650mg/m2，bid.
adjuvant chemotherapy
ACTIVE COMPARATORGemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 1650-2000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered.
Interventions
Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huojun Zhang
Shanghai, Shanghai Municipality, 200433, China
Related Publications (1)
Zhu X, Liu W, Jiang L, Cao Y, Ye Y, Yu C, Yin X, Zhang H. ADJUPANC protocol: a phase III study of adjuvant chemotherapy versus chemoradiotherapy for pancreatic cancer. Future Oncol. 2025 Aug;21(18):2269-2273. doi: 10.1080/14796694.2025.2522061. Epub 2025 Jun 29.
PMID: 40583350DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huojun Zhang, M.D.
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 19, 2024
First Posted
May 23, 2024
Study Start
August 6, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
February 4, 2025
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share