scholarly journals Evaluation of Tumor Resectability Rate and Pathologic Response to Preoperative Concurrent Chemoradiotherapy in Locally Advanced Proximal Gastric and Esophagogastric Junction Adenocarcinomas: A Clinical Trial

2017 ◽  
Vol 10 (5) ◽  
Author(s):  
Seyed Amir Aledavood ◽  
Soodabe Shahid Sales ◽  
Kazem Anvari ◽  
Mohammad Naser Forghani ◽  
Bahram Memar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Esophagogastric Junction ◽  
Concurrent Chemoradiotherapy ◽  
Locally Advanced ◽  
Pathologic Response ◽  
Resectability Rate

Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 523-523
Author(s):  
Suguru Yamada ◽  
Tsutomu Fujii ◽  
Nao Takano ◽  
Hideki Takami ◽  
Masaya Suenaga ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Disease Control ◽  
Phase I Study ◽  
Concurrent Chemoradiotherapy ◽  
Locally Advanced ◽  
Disease Control Rate ◽  
Conversion Surgery ◽  
Level 3 ◽  
Grade 3

523 Background: Gemcitabine plus nab-paclitaxel (GnP) treatment is recommended for metastatic pancreatic adenocarcinoma (PDAC), and has been widely spread in our clinics. However, the usefulness for the patients with locally advanced PDAC is still controversial. We designed the phase I study to assess the toxicity and decide the recommended dose based on dose-limiting toxicity (DLT) of concurrent chemoradiotherapy using GnP for unresectable locally advanced (UR-LA) PDAC. Methods: UR-LA PDAC patients were enrolled in this clinical trial. The patients received the GnP on days 1, 8 and 15 every 28 days, and the cycles were repeated until PD. The patients were scheduled to receive gemcitabine (mg/m2) and nab-paclitaxel (mg/m2) at 5 dose levels: 400/75 (level 0), 600/75 (level 1), 600/100 (level 2), 800/100 (level 3) and 800/125 (level 4). Radiation therapy was delivered as a total dose of 50.4 Gy in 28 fractions, 1.8Gy per day. DLT was defined as grade 4 leucopenia or neutropenia ≥ 3 days, grade 3 neutropenia with fever ≥ 38℃, grade 3 or 4 thrombopenia, grade 3 non-hematological toxicity and > 14 days delay of treatment. Response and disease control rate, safety, adverse events, PFS and OS were evaluated. Results: Twelve patients were enrolled in this study. Treatment was well tolerated, and every 12 patients completed radiotherapy of 50.4 Gy. Our recommended dose was level 3, gemcitabine 800 mg/m2 and nab-paclitaxel 100 mg/m2. One patient experienced the DLT. The response rate was 41.7% and disease control rate was 75% (PR: 5, SD: 4, PD: 3). Median OS was 9.0 months. Among 12 patients, 6 (50%) patients underwent conversion surgery, and the pathological CR was observed in 2 patients. Conclusions: The concurrent chemoradiotherapy using GnP for UR-LA PDAC can be delivered safely and the high rate of conversion surgery was observed in our clinical trial. Based on this results, we will proceed the phase-II study. Clinical trial information: UMIN000020475.

Phase II study of concurrent S-1/cisplatin and radiation therapy in locally advanced or metastatic esophageal cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14154-14154
Author(s):  
S. Cho ◽  
H. Shim ◽  
J. Ahn ◽  
D. Yang ◽  
Y. Kim ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Concurrent Chemoradiotherapy ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Economic Problem ◽  
Pathologic Response ◽  
End Point ◽  
First Line Therapy ◽  
History Of ◽  
Grade 3

14154 Background: Although 5-FU and cisplatin had been widely used as radiosensitizer, the toxicities such as mucositis or bone marrow suppression were problematic. In this study, 5-FU was replaced with S-1. The primary end point of this study was to define the safety and the secondary end point was to evaluate the pathologic response and clinical efficacy as the first line therapy in locally advanced or metastatic esophageal cancer. Methods: Patients with locally advanced or metastatic esophageal cancer without history of previous chemotherapy or radiotherapy were eligible. Cisplatin was given intravenously with 75 mg/m2 on day 1 every 3 weeks. S-1 was administered at the dose of 80 mg/m2/day orally divided two times for 2 weeks followed by 1 week rest. Radiotherapy was started concomittently at day 1, total dose of 5040 cGY for 6 weeks. During radiotherapy, patients received 2 cycles of chemotherapy. Results: From May 2004 to Aug 2005, 33 patients were enrolled into this study. 6 patients were dropped out due to poor compliance (3), economic problem (2) and TEF (1) during treatment. 27 patients were evaluable for response and toxicity. The median age was 66 years (range, 54–82). Clinical response was 77.8% (21 pts) and pathologic response was shown in 29.6% (8 pts). The improvement of dysphagia was shown in 22 patients (81.5%). There were 7 (25.9%) pts with grade 3 neuropenia. Grade 3–4 odynophagia during concurrent chemoradiotherapy was observed only one patient. Conclusions: The concurrent chemoradiotherapy combined with S-1 and cisplatin was well tolerated and effective in advanced esophageal cancer to relieve obstructive symptoms and tumor regression. No significant financial relationships to disclose.

Camrelizumab in combination with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma: A single-arm, open-label, phase II study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16072-e16072
Author(s):  
Feng Wang ◽  
Yu Qi ◽  
Xiangrui Meng ◽  
Qingxia Fan
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Preoperative Chemotherapy ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Pathologic Response ◽  
R0 Resection ◽  
Efficacy And Safety ◽  
Clinical Trial Information

e16072 Background: At present, ESCC has a dismal prognosis with huge unmet clinical needs. With the potential benefit of combining PD-1 inhibitor with nCT, we conducted a phase II trial to assess the efficacy and safety of Camrelizumab plus nCT for locally advanced ESCC. Methods: 43 patients (pts) with histologically confirmed stage II/III/IVa(cT2-4aN0-3M0) ESCC were enrolled from February 2020 to February 2021.The study was divided into two stages, stage 1: we administered 1 cycle of camrelizumab for induction therapy (200 mg q2 weeks); stage2: pts received 2 cycle of camrelizumab (200 mg every 3 weeks) plus docetaxel and nedaplatin, followed by surgery within 4̃6 weeks after neoadjuvant therapy completion. Primary endpoint was major pathologic response (MPR). Secondary endpoints included pathologic complete response (pCR), R0 resection rate, disease-free survival (DFS) and overall survival (OS). Results: At the cutoff date of Feb 5, 2021, 43 eligible pts were enrolled (63% males, median age 66), neoadjuvant treatment was completed in 33 pts and is ongoing in 3 pts. Thus far 27 out of 33 pts were resected, 6 pts are planned to undergo surgery, 3 pts were not suitable for operation after evaluation,1 pt had interval metastases preoperatively, 1 pt declined surgery, 1 pt was allergic to camrelizumab, 1 pt died due to unknown reasons. All patients underwent an R0 resection. Postoperative pathology showed that TNM stage decreased in 23 pts with 85.19% reduction rate. 17 pts (62.96%) reached major pathologic response, 8 pts (29.63%) reached pathologic complete response (no surgery related mortality). The most common AEs (all grade, grade≥3) were reduced hemoglobin (53%, 0%), hypoproteinemia (26%, 0%), neutrophil (21%, 12%), TSH reduction (21%, 0%), increased blood lactate dehydrogenase (16%, 0%), hyperthyroidism (16%, 0%), elevated alanine aminotransferase (9%, 0%), fatigue (7%, 0%), rash (5%, 2%). Date for median DFS and OS were not matured. Conclusions: Camrelizumab in combination with preoperative chemotherapy followed by surgery for locally advanced ESCC showed promising downstaging effect and MPR with good tolerance, and its efficacy and safety could be further studied in later trials. Clinical trial information: NCT03917966. Clinical trial information: NCT03917966.

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