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Exploratory assessment of the efficacy and safety of gemcitabine-albumin-based paclitaxel chemotherapy combined with SBRT in the treatment of newly diagnosed borderline resectable and locally advanced unresectable pancreatic cancer patients with sequential investigator selection (IC).
The question of how to administer adequate chemotherapy to synchronize SBRT treatment strategy to maximize the benefits of neoadjuvant therapy for improved prognosis of patients with borderline resectable (BRPC) and locally advanced (LAPC) pancreatic cancer is a challenging and debatable issue. No studies have yet evaluated the efficacy of split-course SBRT as the neoadjuvant chemoradiotherapy regimen. The investigators aimed to study whether neoadjuvant chemotherapy plus split-course SBRT results in better outcomes in BRPC and LAPC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT with concurrent chemotherapy | Experimental | SBRT with nab-Paclitaxel plus Gemcitabine (nab-P+Gem) chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-Paclitaxel+Gemcitabine | Drug | Drug: nab-Paclitaxel 125 mg/m2 IV over approximately 30-45 min on Days 1 and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 min on Days 1 and 15 of each 28-day cycle for 6 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) | Progression-free Survival (PFS) was defined as the time from the date of the first dose to the date of disease progression or death (by any cause), whichever is earlier. The analysis day was calculated from enrollment date for one participant who was not treated. Participants who have no disease progression or have not died were censored to last tumor assessment date with progression-free. | From enrollment to 2 years after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimates for Time to Treatment Failure (TTF) | TTF was defined as the time after the first dose of study therapy to discontinuation of study therapy due to disease progression, death by any cause, or the start of a new non-protocol-defined anticancer therapy/surgery. | From enrollment to 2 years after the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benhua Xu, PHD | Contact | +86-13696884375 | benhuaxu@163.com | |
| Rong Zheng, PHD | Contact | +86 18659103321 | zhengrrong@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Benhua Xu, PHD | Fujian Medical University Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28055103 | Background | Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. | |
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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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| split-course SBRT | Radiation | Radiation: During the first 1 and 2 cycles of chemotherapy, SBRT was given as a single irradiation of 10 Gy â…¹ 4 times (Days 2 and 16 of each 28-day cycle). |
|
| Disease Control Rate (DCR) |
DCR was defined as the percentage of participants with a CR or PR or SD from of date of first treatment to 16 weeks. Tumor assessments after start of non-protocol-defined anticancer therapy were excluded. |
| From enrollment to 2 years after the end of treatment |
| Overall Response Rate (ORR) | ORR was defined as the percentage of participants that achieved a combined incidence of complete (CR) and partial response (PR) using RECIST 1.1 guidelines as assessed by the investigator. | From enrollment to 2 years after the end of treatment |
| Kaplan-Meier Estimates for Overall Survival (OS) | Overall survival was defined as the time from the date of first dose of study therapy to the date of death (by any cause). | From enrollment to 2 years after the end of treatment |
| Participants With Treatment Emergent Adverse Events (TEAEs) | TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. | From enrollment to 2 years after the end of treatment |
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| 33154057 | Derived | Zheng R, Wang C, Huang X, Lin Q, Huang D, Li XB, Huang H, Xu B. Chemotherapy-based split stereotactic body radiation therapy for borderline resectable and locally advanced pancreatic cancer: study protocol of a prospective, single-arm phase II trial. BMJ Open. 2020 Nov 5;10(11):e039900. doi: 10.1136/bmjopen-2020-039900. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |