Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study

Study Overview
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Brief Summary
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This is a prospective observation cohort study to evaluate efficacy of different types of adjuvant therapy strategies, including chemoradiotherapy, chemotherapy alone, or no adjuvant treatment, for pancreatic ductal adenocarcinoma patients who received surgical resection of primary cancer.

Official Title
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Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study

Conditions
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Surgery, Resectable Pancreatic Cancer, Adjuvant Chemoradiotherapy

Intervention / Treatment
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* Other: Follow-up only
* Drug: Adjuvant chemotherapy
* Radiation: Adjuvant chemoradiotherapy
* Radiation: Adjuvant chemoradiotherapy + Adjuvant chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 to 90 years. Received surgical resection of primary tumor. Histological diagnosis of pancreatic ductal adenocarcinoma. Signed informed consent. Exclusion Criteria: 1.Active concomitant malignancy (Malignancy other than pancreatic cancer).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No adjuvant treatment<br>Pancreatic cancer patients who received surgery without subsequent adjuvant treatment. | Other: Follow-up only<br>* Only routine follow-up but no treatment<br>|
| Adjuvant chemotherapy<br>Pancreatic cancer patients who received surgery and only adjuvant chemotherapy. | Drug: Adjuvant chemotherapy<br>* Chemotherapy regimens will be decided by physicians or MDT teams, basing on patients' physical status, income status, and/or desire. Toxicity was evaluated every cycle and efficacy was evaluated every two cycles. The treatment course of adjuvant chemotherapy was followed the recommendation of NCCN guideline.<br>|
| Adjuvant chemoradiotherapy<br>Pancreatic cancer patients who received surgery and only adjuvant chemoradiotherapy. | Radiation: Adjuvant chemoradiotherapy<br>* Adjuvant CRT could be delivered before or simultaneously with adjuvant chemotherapy. Radiation used 6 MV or 15 MVX-ray beams delivering daily fractions of 180-200cGy to a total dose of 45-55Gy in 25-28 fractions using CT-based, three-dimensional conformal radiation therapy (3DRT), intensity-modulated radiation therapy (IMRT) or tomotherapy (TOMO). S-1 was administered orally at a dose of 40mg twice a day during radiation day as radiosensitizer through radiotherapy. Antiemetic medications and proton pump inhibitor were prophylactic used to reduce the occurrence of nausea and inhibit gastric acid secretion.<br>|
| Adjuvant chemoradiotherapy + adjuvant chemotherapy<br>Pancreatic cancer patients who received surgery and both adjuvant chemoradiotherapy and chemotherapy. | Radiation: Adjuvant chemoradiotherapy + Adjuvant chemotherapy<br>* See as above (adjuvant chemotherapy and adjuvant chemoradiotherapy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival (OS) was defined as the time interval from the date of surgery to the date of death due to any cause or the date a patient was last known to be alive. Estimated by using the Kaplan-Meier method. | Up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival | Disease free survival (DFS) was defined as the time interval from the date of surgery to the date of disease recurrence or death or the date of a participant was last known to be alive without disease recurrence. Response was evaluated according to revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Up to 48 months |