A Prospective Phase II Trial of Neoadjuvant S-1 with Concurrent Hypofractionated Radiotherapy in Patients with Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma

2017 ◽  
Vol 24 (9) ◽  
pp. 2777-2784 ◽  
Author(s):  
Keiichi Okano ◽  
Hironobu Suto ◽  
Minoru Oshima ◽  
Eri Maeda ◽  
Naoki Yamamoto ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Hypofractionated Radiotherapy ◽  
Ductal Adenocarcinoma ◽  
Borderline Resectable ◽  
Prospective Phase

Neoadjuvant gemcitabine/cisplatin for resectable adenocarcinoma of the pancreatic head—a prospective phase I trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15095-15095
Author(s):  
S. Heinrich ◽  
B. Pestalozzi ◽  
M. Schafer ◽  
T. Hany ◽  
P. Bauerfeind ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Pancreatic Head ◽  
Serum Levels ◽  
Ductal Adenocarcinoma ◽  
Primary Study ◽  
Prospective Phase

15095 Background: Pancreatoduodenectomy (PD) alone was considered a standard treatment for cancer of the pancreatic head for a long time before the recent advent of adjuvant chemotherapy (CTX). Since adjuvant chemotherapy cannot be applied to all patients (pts), and neoadjuvant chemoradiation is toxic, we initiated a prospective phase II trial in August 2001 to test the safety and outcome of neoadjuvant CTX without radiation for resectable pancreatic cancer. Methods: Pts with cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head were eligible for this phase II trial. Staging and restaging examinations included chest and abdominal CT-scan, endoscopic ultrasound with cytology, PET/CT and diagnostic laparoscopy. CTX consisted of four treatments of gemcitabine (1000mg/m2) and cisplatin (50mg/m2) every two weeks, and PD was planned at week 8. CA 19–9, prealbumin serum levels, and quality of life (QLQ- 30) were also determined before and after CTX. The primary study end-point was resectability based on re-staging examinations. Follow-up CT- scans were performed every six months. Results: Thirty-one pts entered this trial. Of these, 27 completed CTX and restaging until analysis. At restaging two pts had peritoneal metastases resulting in a resectability rate of 93% (25/27). No grade IV, and 7 transient grade III toxicities occurred in five pts. Median progression-free and overall survival after diagnosis were 9.2 months (95% CI 7.7–10.8) and 26.5 months (95% CI 15.2–37.7), respectively, for resected pts. After CTX, CA 19–9 serum levels were decreased by 48% (p=0.01). Moreover, the overall quality of life was increased by 24% (p=0.02). Prealbumin serum levels were abnormal in 40% of the pts on study entry, and normal in all but 89% after CTX (p=0.02). Conclusions: Neoadjuvant gemcitabine/cisplatin over two months is well tolerated and does not jeopardize resectability of adenocarcinoma of the pancreatic head. It offers several advantages including patient selection for surgery, improvements in the nutritional status and quality of life. A randomized trial comparing adjuvant and neoadjuvant+adjuvant treatment is being planned. No significant financial relationships to disclose.

Prospective phase II trial of neoadjuvant chemotherapy with gemcitabine and S-1 (GS) for borderline resectable (BR)/unresectable (UR) pancreatic cancer (CAP-003 study).

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e16225-e16225
Author(s):  
Hideyuki Yoshitomi ◽  
Shigetsugu Takano ◽  
Shingo Kagawa ◽  
Katsunori Furukawa ◽  
Tsukasa Takayashiki ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Borderline Resectable ◽  
Prospective Phase

Neoadjuvant chemotherapy with gemcitabine and S-1 for resectable and borderline pancreatic ductal adenocarcinoma: A prospective, multi-institutional, phase II trial.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 283-283 ◽  
Author(s):  
Masamichi Mizuma ◽  
Fuyuhiko Motoi ◽  
Kazuyuki Ishida ◽  
Fumiyoshi Fujishima ◽  
Shigeru Ottomo ◽  
...  
Keyword(s):  
Survival Rate ◽  
Neoadjuvant Chemotherapy ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Surgical Resection ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Distant Metastases ◽  
Ductal Adenocarcinoma ◽  
Institutional Setting ◽  
Resection Rate

283 Background: Although surgical resection is the only curative treatment for pancreatic ductal adenocarcinoma (PDAC), recurrence rates are very high even if complete resection is performed. Accordingly, a new therapeutic strategy against PDAC is needed. Combination with gemcitabine and S-1 (GS) as first line chemotherapy is promising. The purpose of this study is to evaluate the feasibility and efficacy of GS for resectable and borderline PDAC in the neoadjuvant chemotherapy (NAC). Methods: This study is a prospective, multi-institutional, single-arm, phase II trial. Neoadjuvant chemotherapy with gemcitabine and S-1(NAC-GS) for resectable and borderline PDAC was performed as follows. Gemcitabine was given at a dose of 1,000 mg/m2 on days 1 and 8 of each cycle. S-1 was administered orally at a dose of 40 mg/m2 twice daily for the first 14 consecutive days followed by a 7-day rest. Each cycle was repeated every 21 days. The primary endpoint was the 2-year survival rate. Secondary endpoints were feasibility, resection rate, pathological effect, recurrence-free survival and tumor marker status. Results: 36 patients were enrolled between 2008 and 2010. 35 were eligible for participation in this trial. The most common toxicity was neutropenia in response to 90% of the relative dose intensity. Radiological tumor shrinkage and decreases of CA19-9 levels were seen in 69% and 89%, respectively. R0 resection rate was 87%, and the morbidity rate (40%) was acceptable. The 2-year survival rate of the total cohort was 45.7%. Patients undergoing surgical resection without distant metastases after NAC-GS (n=27) showed an increased median overall survival (34.7 months), compared with 10.0 months for resection with distant metastases or non-resection (p=0.0017). Conclusions: NAC-GS is safe and well tolerated in a multi-institutional setting. NAC-GS is encouraging patients with resectable and borderline PDAC because of better outcomes. Clinical trial information: UMIN-000001504.

Phase II study of preoperative chemotherapy with nab-paclitaxel and gemcitabine followed by chemoradiation for borderline resectable or node-positive pancreatic ductal adenocarcinoma.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 697-697
Author(s):  
Emerson Yu-sheng Chen ◽  
Garth William Tormoen ◽  
Adel Kardosh ◽  
Nima Nabavizadeh ◽  
Bryan Foster ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Operative Treatment ◽  
Phase Ii ◽  
Metastatic Disease ◽  
Pancreatic Resection ◽  
Operative Therapy ◽  
Ductal Adenocarcinoma ◽  
R0 Resection ◽  
Borderline Resectable ◽  
Node Positive

697 Background: Pre-operative therapy for resectable pancreatic ductal adenocarcinoma (PDAC) may eliminate micro-metastatic disease early and help achieve negative surgical margins. The present study is based on the hypothesis that gemcitabine/nab-paclitaxel chemotherapy followed by chemo-radiation with fluoropyrimidine is a feasible and efficacious pre-operative treatment for borderline resectable or node-positive PDAC. Methods: This is a single-arm phase II trial to evaluate pre-operative treatment with 2 cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 on days 1, 8, 15 every 28 days followed by 50.4 Gy of intensity-modulated radiation therapy over 28 fractions with concurrent 5-fluorouracil or capecitabine prior to pancreatic resection. Patients were eligible if they met borderline resectable criteria or had abnormal regional nodes visible on contrast CT. After surgery, they were eligible to receive up to 4 additional cycles of gemcitabine/nab-paclitaxel. The primary endpoint was the R0 resection rate. Secondary endpoints included response to pre-operative therapy, overall toxicities, relapse-free survival, and overall survival. Results: Nineteen of 24 screened patients have been enrolled. Median age was 68, 10 (53%) were female, and 4 (21%) were non-Caucasian. Eleven (78%) had head of pancreas cancers, 13 (68%) exhibited both arterial and venous involvement, and 12 (63%) had positive clinical nodes. All 19 patients received 2 months of gemcitabine/nab-paclitaxel, of which 17 patients continued to chemo-radiation (1 developed metastatic disease and 1 moved out of state). In the interval between chemo-radiation and surgery, 3 developed metastatic disease, 1 became unresectable, 1 withdrew from study, and 1 was deemed too frail for surgery. Nine have undergone successful pancreatic resection, and 2 are pending resection. Conclusions: Pre-operative gemcitabine/nab-paclitaxel followed by chemo-radiation with fluoropyrimidine is feasible in patients with borderline resectable PDAC and represents another strategy to FOLFIRINOX-based therapy. A planned interim analysis is ongoing. Clinical trial information: NCT02427841.

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