Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)

Trial Title: Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)

NCT ID: NCT06427447

Condition: Pancreatic Cancer

Conditions: Official terms:
Pancreatic Neoplasms

Conditions: Keywords:
pancreatic cancer
adjuvant chemoradiotherapy
adjuvant chemotherapy

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Combination Product
Intervention name: Adjuvant chemoradiotherapy
Description: Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine)
Arm group label: adjuvant chemoradiotherapy

Intervention type: Drug
Intervention name: Adjuvant chemotherapy
Description: Chemotherapy (gemcitabine plus capecitabine)
Arm group label: adjuvant chemotherapy

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.

Detailed description: Pancreatic cancer is a lethal malignancy with the lowest 5-year overall survival rate of 9% and an increasing incidence. In China, the mortality of pancreatic cancer ranked the sixth among all cancers. Although surgical resection is the only radical treatment, only less than 20% patients could receive upfront surgery at the initial diagnosis. Even though patients have surgery, the incidence of disease progressions, including local progression and metastasis, is about 80-90%. In NCCN guidelines and Chinese guidelines, adjuvant chemotherapy is recommended for post-operative pancreatic cancer, while adjuvant chemoradiotherapy could also be used. However, it has not been clarified that which patients may benefit from adjuvant chemoradiotherapy, and no high-level evidence has shown the advantages of adjuvant chemoradiotherapy over chemotherapy. In meta-analyses, it was demonstrated that patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion could achieve longer survival after adjuvant chemoradiotherapy compared with chemotherapy. Therefore, we aim to compare the outcomes of adjuvant chemoradiotherapy with those of chemotherapy in patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion after surgical resection of pancreatic cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Aged 18-75 years - Pathologically confirmed pancreatic ductal adenocarcinoma - Pathologically confirmed lymph node metastasis, R1 or R2 resection or perineural 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 Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Huojun Zhang

Address:
City: Shanghai
Zip: 200433
Country: China

Status: Recruiting

Contact:
Last name: Xiaofei Zhu, M.D.

Phone: 86-021-31162222
Email: zhuxiaofei_zxf@163.com

Investigator:
Last name: Huojun Zhang, M.D.
Email: Principal Investigator

Start date: May 12, 2024

Completion date: June 30, 2029

Lead sponsor:
Agency: Changhai Hospital
Agency class: Other

Source: Changhai Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06427447