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This trial aimed to determine whether neoadjuvant chemoradiotherapy improves overall survival compared with upfront surgery, both followed by adjuvant chemotherapy in patients with resectable and borderline resectable pancreatic cancer.
Pancreatic cancer is one of the solid cancers with the poorest treatment outcomes, and there is an urgent need to improve its treatment outcomes. Among these, resectable pancreatic cancer is known to show relatively good treatment outcomes with surgical resection, but the 5-year survival rate is still about 20%, which is still unsatisfactory.
Neoadjuvant therapy may increase the proportion of patients that actually receive chemotherapy and thereby improve survival. Furthermore, neoadjuvant therapy may increase the microscopically margin-negative (R0) resection rate and may identify patients with rapidly progressive disease who can be spared futile surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate surgery group | Patients will undergo upfront surgery, then adjuvant chemotherapy. |
| |
| Neoadjuvant chemotherapy group | Patients will undergo neoadjuvant chemotherapy, then surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate surgery | Procedure | Patients will undergo upfront surgery, then adjuvant chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | Overall survival will be measured as the time between date of randomization and date of death from any cause or date of last follow-up if alive. | 1 year post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Achieve of R0 Resection | Resection is defined as the number of patients with an R0 resection margin. R0 resection margin rate will be measured according to the Africa Regional Collaborative Platform (RCP) report on standards and datasets for reporting cancers. | 1 year post-procedure |
| Disease free survival |
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Inclusion Criteria:
Exclusion Criteria:
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This prospective and retrospective study will be conducted on 30 patients with resectable pancreatic cancer.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia University | Minya | Minya Governorate | 61611 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Neoadjuvant chemotherapy | Procedure | Patients will undergo neoadjuvant chemotherapy, then surgery. |
|
Disease-free survival will be measured as the time between date of surgery and date of disease recurrence. |
| 1 year post-procedure |
| Time to locoregional recurrence | Time to locoregional recurrence will be recorded. | 1 year post-procedure |
| Time to distant metastasis | Time to distant metastasis will be recorded. | 1 year post-procedure |
| Incidence of postoperative complications | Incidence of postoperative complications such as hemorrhage and pancreatic fistula will be recorded. | 1 year post-procedure |
| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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