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Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.
Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy | Active Comparator | gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. |
|
| chemotherapy with chemoradiation | Experimental | gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | From date of randomization until the date of death from any cause, assessed up to 36 months | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | from randomization to 1 month after end of treatment |
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Inclusion Criteria:
Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes.
Subject should start treatment no later than 10 weeks postsurgery.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Acceptable hematology parameters:
Acceptable blood chemistry levels:
Cancer antigen (CA)19-9 ≤ 2.5 x upper Limit of Normal (ULN) assessed within 14 days of randomization.
No disease recurrence or metastases detected on CT/MRI assessed within 30 days of randomization.
Signed informed consent.
Exclusion Criteria:
R2 resection or presence of metastatic disease.
Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.
Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
Severe, active co-morbidity, defined as follows:
Not able to take medicine orally.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bai Chunmei, MD | Contact | 861069158773 | baichunmei1964@163.com | |
| Cheng Yuejuan, MD | Contact | 861069158773 | cnchengyuejuan@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Medical Oncology, Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
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| TS-1 with radiation | Radiation | gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation. |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D004358 | Drug Therapy |
| C103828 | titanium silicide |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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