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2024-08-06
2028-06-30
2029-06-30
770
NCT06427447
Changhai Hospital
Changhai Hospital
INTERVENTIONAL
Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-05-19 | N/A | 2025-01-31 |
2024-05-19 | N/A | 2025-02-04 |
2024-05-23 | N/A | 2024-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: adjuvant chemoradiotherapy Chemotherapy: 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, | COMBINATION_PRODUCT: Adjuvant chemoradiotherapy
|
| ACTIVE_COMPARATOR: adjuvant chemotherapy 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. | DRUG: Adjuvant chemotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival will be determined. | The time from the randomization to death. | 3 years |
| 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 |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xiaofei Zhu Phone Number: 86-021-31162222 Email: zhuxiaofei_zxf@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
