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This study is to investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-paclitaxel with SBRT and S-1 plus nab-paclitaxel with SBRT.
This research study is a Phase II clinical trial that investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-paclitaxel with SBRT and S-1 plus nab-paclitaxel with SBRT. It is known that neoadjuvant therapy is vital for improved survival, which has been confirmed in previous studies that neoadjuvant chemotherapy with or without radiotherapy provides superior overall compared with upfront surgery. However, question of whether the addition of radiotherapy to neoadjuvant chemotherapy can improve prognosis compared with chemotherapy alone is a challenging matter. Also, no studies have evaluated the efficacy of S-1 as the neoadjuvant chemotherapy regimen for BRPC albeit similar prognosis has been found between S-1 and gemcitabine in advanced pancreatic cancer. In this trial, patients with biopsy and radiographically confirmed BRPC will be randomly allocated into three groups: neoadjuvant gemcitabine plus nab-paclitaxel, neoadjuvant gemcitabine plus nab-paclitaxel with SBRT and neoadjuvant S-1 plus nab-paclitaxel with SBRT. Surgical resection will be performed 3 weeks after SBRT. The primary endpoint is overall survival. The secondary outcomes are progression free survival, pathological complete response rate, R0 resection rate and incidence of adverse effects. If results show the survival benefits of neoadjuvant chemotherapy plus SBRT and similar outcomes between S-1 and gemcitabine, it may provide evidence of clinical practice of this modality for BRPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A of neoadjuvant chemotherapy | Active Comparator | Neoadjuvant gemcitabine plus nab-paclitaxel is used in this group. Intravenous administration of gemcitabine (1000mg/m2) and nab-paclitaxel (125 mg/m2) are initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. And surgical resection is performed after completion of the whole chemotherapy. |
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| Group B of neoadjuvant chemoradiotherapy | Experimental | Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT is used in this group. Intravenous administration of gemcitabine (1000mg/m2) and nab-paclitaxel (125 mg/m2) are initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. After completion of the whole chemotherapy, patients will first receive PET-CT to exclude distant metastases and then undergo SBRT. The prescribed dose is 7.5-8Gy/f for 5 fractions. Dose constraints of normal tissues are referred to the American Association of Physicists in Medicine guidelines in TG-101. And surgical resection is performed 3 weeks after SBRT. |
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| Group C of neoadjuvant chemoradiotherapy | Experimental | Neoadjuvant S-1 plus nab-paclitaxel with SBRT is used in this group. Intravenous administration of nab-paclitaxel (125 mg/m2) is initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. And S-1 is orally administrated at a dose of 80 mg/m2 for 18 days followed by a 10-day rest during each 4-week cycle, which aslo continues for 3 cycles. After completion of the whole chemotherapy, patients will first receive PET-CT to exclude distant metastases and then undergo SBRT. The prescribed dose is 7.5-8Gy/f for 5 fractions. Dose constraints of normal tissues are referred to the American Association of Physicists in Medicine guidelines in TG-101. And surgical resection is performed 3 weeks after SBRT. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant gemcitabine plus nab-paclitaxel | Drug | Neoadjuvant gemcitabine plus nab-paclitaxel is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. Surgical resection will be performed after neoadjuvant chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall time | The time between operation and the death of patients | From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free time | The time between operation and the relapse or metastasis of tumors | From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiwei Guo, Doctor | Contact | +8618621500666 | gestwa@163.com | |
| Suizhi Gao, Master | Contact | +8613167137990 | gaosuizhi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gang Jin, Doctor | Changhai Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30917842 | Derived | Gao S, Zhu X, Shi X, Cao K, Bian Y, Jiang H, Wang K, Guo S, Zhang H, Jin G. Comparisons of different neoadjuvant chemotherapy regimens with or without stereotactic body radiation therapy for borderline resectable pancreatic cancer: study protocol of a prospective, randomized phase II trial (BRPCNCC-1). Radiat Oncol. 2019 Mar 27;14(1):52. doi: 10.1186/s13014-019-1254-8. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT | Drug | Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. The radiation dose of SBRT is 7.5-8Gy/f for 5 fractions. Surgical resection will be performed 3 weeks after SBRT. |
|
| Neoadjuvant S-1 plus nab-paclitaxel with SBRT | Drug | Neoadjuvant S-1 plus nab-paclitaxel with SBRT is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. The radiation dose of SBRT is 7.5-8Gy/f for 5 fractions. Surgical resection will be performed 3 weeks after SBRT. |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |