Adjuvant Chemoradiotherapy, Resectable Pancreatic Cancer, Surgery
Conditions
Brief summary
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.
Interventions
OTHERFollow-up only
Only routine follow-up but no treatment
DRUGAdjuvant chemotherapy
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.
RADIATIONAdjuvant chemoradiotherapy
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.
RADIATIONAdjuvant chemoradiotherapy + Adjuvant chemotherapy
See as above (adjuvant chemotherapy and adjuvant chemoradiotherapy).
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 to 90 years. 2. Received surgical resection of primary tumor. 3. Histological diagnosis of pancreatic ductal adenocarcinoma. 4. Signed informed consent.
Exclusion criteria
1.Active concomitant malignancy (Malignancy other than pancreatic cancer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 60 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival | Up to 48 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events | Up to 60 months | Number of participants experiencing adverse events during chemoradiation and during adjuvant chemotherapy, at any grade, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. This is used to determine the Toxicity profile. |
Countries
China
Contacts
Primary ContactYaolin Xu, M.D.
Backup ContactWenhui Lou, M.D., Ph.D
Outcome results
None listed