Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pancreatic cancer is a highly fatal malignant tumor. Simple surgical operations can no longer meet the treatment needs of pancreatic cancer patients. Postoperative adjuvant chemotherapy has a significant effect, which can effectively prevent or delay tumor recurrence and prolong the overall survival period of pancreatic cancer patients. Based on this, many guidelines both at home and abroad actively recommend that pancreatic cancer patients receive adjuvant chemotherapy after surgery (if there are no contraindications). Radiotherapy is one of the most commonly used local treatment methods. It can be used as a neoadjuvant or adjuvant therapy to increase the tumor resection rate or reduce the recurrence rate, or as a treatment approach for locally unresectable pancreatic cancer to improve local control. After complete gross resection of pancreatic cancer, the role of radioadjuvant therapy has always been controversial, and its indications for use remain unclear. However, recent clinical studies using modern radiotherapy equipment and techniques have shown that an increasing amount of data indicates that radiotherapy can benefit in the treatment of neoadjuvant, adjuvant and locally advanced pancreatic cancer. Evidence supporting adjuvant radiotherapy after pancreatectomy remains scarce. Therefore, whether screening high-risk factor populations for adjuvant radiotherapy may improve the prognosis of pancreatic cancer is an important research.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy plus GX group | Experimental | After 3 cycles of GX chemotherapy, capecitabine is taken orally simultaneously with radiotherapy. After concurrent chemoradiotherapy, continue with GX chemotherapy. |
|
| GX group | Active Comparator | Gemcitabine and Capecitabine, repeated every 21 days as one cycle. Administration for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy + GX | Radiation | After 3 cycles of GX chemotherapy, capecitabine is taken orally simultaneously with radiotherapy. After concurrent chemoradiotherapy, continue with GX chemotherapy. Radiotherapy target and dose: Tumor bed, anastomosis, adjacent lymphatic drainage area :50 Gy; R1 resection area: 60 Gy; R2 resection area: 66-70 Gy (silver clip position), once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Defined as the time from random assignment to the first tumor recurrence, metastasis or death of the subject for any reason (whichever occurs first) | From date of randomization until the first tumor recurrence, metastasis or death of the subject for any reason (whichever occurs first) assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | The time from random assignment to death due to any cause. | From date of randomization until death from any cause or last follow-up, assessed up to 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maobin Meng | Contact | 022-23340123-1111 | mmeng@tmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin medical university hospital and institute | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D054509 | Group X Phospholipases A2 |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D054497 | Phospholipases A2, Secretory |
| D054467 | Phospholipases A2 |
| D010741 | Phospholipases A |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| GX group | Drug | Gemcitabine (G): Intravenous infusion of 1000 mg/m2 for more than 30 minutes, administered on day 1 and day 8, repeated every 21 days. Capecitabine (X): 1660-2000mg/m2 per day, taken orally in two divided doses, from day 1 to day 14, repeated every 21 days as one cycle. Administration for 6 cycles, every 3 weeks . |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010740 |
| Phospholipases |
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |