Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)

Pancreatic Cancer Clinical Trial

— ADJUPANC  

Official title:

Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06427447
• Other study ID #: CH hospital
• Status: Recruiting
• Phase: Phase 3
• Start date: May 12, 2024
• Est. completion date: June 30, 2029

Study information

• Verified date: May 2024
• Source: Changhai Hospital
• Contact: Xiaofei Zhu
• Phone: 86-021-31162222
• Email: zhuxiaofei_zxf[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 770
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Combination Product:
• Adjuvant chemoradiotherapy
Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine)

Drug:
• Adjuvant chemotherapy
Chemotherapy (gemcitabine plus capecitabine)

Locations

Country	Name	City	State
China	Huojun Zhang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival will be determined.	The time from the randomization to death.	3 years
Secondary	Treatment-related adverse events will be determined.	Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.	3 years
Secondary	Quality of life will be determined.	The analysis of quality of life is based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). All scales and subscales range from 0 to 100. Regarding physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning and global health, higher scores may indicate better outcomes. In the case of fatigue, nausea and vomitting, pain, dyspnea, insomina, appetite loss, constipation, diarrhea and financial difficulties, lower scores may indicate better outcomes. Scales of all items are independent and not combined to compute a total score.	3 years