Efficacy and safety of conversion therapy using chemotherapy plus anti-angiogenic therapy in unresectable gastric cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15510-e15510
Author(s):  
Lu chuan Chen
Keyword(s):  
Gastric Cancer ◽  
Safety Profile ◽  
R0 Resection ◽  
Preoperative Treatment ◽  
Efficacy And Safety ◽  
Conversion Therapy ◽  
Resection Rate ◽  
Efficacy Evaluation ◽  
Local Progression ◽  
Unresectable Gastric Cancer

e15510 Background: Conversion therapy has been a promising option for patients with unresectable gastric cancer (GC) (including Phase IV gastric cancer, N3, lymph node fusion and local progression patients). We aimed to investigate the efficacy and safety of S1/oxaliplatin chemotherapy plus apatinib, a novel inhibitor of VEGFR-2, in the conversion therapy for unresectable GC. Methods: This was a single-center, single-arm, open-label study. unresectable GC patients with unresectable factors were eligible for this study. Apatinib (500mg, qd) was administrated continuously, oxaliplatin (130mg/m2) on day 1, and S1 (<1.25m2, 40mg*2/d; 1.25-1.5m2, 50mg*2/d; >1.5m2, 60mg*2/d) on day 1-14 every 3 weeks. Treatment was given for 4-6 cycles preoperatively, but the last cycle did not include apatinib. The primary objective included R0 resection rate and safety profile of preoperative treatment. Results: Total 17 patients were enrolled, the median age was 57 (55.12±10.08) years old. The histological types were mainly signet ring cell carcinoma 10 (58.82%), poorly differentiated adenocarcinoma 5 (29.41%), and moderately differentiated adenocarcinoma 2 (11.76%). Among the 17 patients eligible for preoperative efficacy evaluation, 13 achieved partial response (PR), 3 achieved stable disease (SD), and 1 had progressive disease (PD), the overall response rate (ORR) was 76.5% and disease control rate was 94.1%. Of the 13 pts with PR, 1 refused consents for surgery, 12 patients underwent surgery and 9(75%) achieved R0 resection. During preoperative treatment, the incidence of adverse events (AEs) was 76.5%. The common hematologic AEs were neutropenia (64.7%), leukopenia (64.7%) and hemoglobin decrease (11.8%), and nonhematologic AEs included hyperbilirubinemia (11.8%), hand-foot syndrome (17.6%), oral mucositis (29.4%), fatigue (70.6%), proteinuria (5.9%). Conclusions: Combination of apatinib with S1/oxaliplatin chemotherapy could induce a sufficient conversion rate and achieve a relative high R0 resection rate for initially unresectable GC, with tolerable safety profile. Clinical trial information: ChiCTR-ONC-17010430 trial.

Phase II study of conversion therapy using S1/paclitaxel chemotherapy plus apatinib in unresectable gastric cancer (Ahead-G325 trial).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 53-53 ◽  
Author(s):  
Xiangdong Cheng ◽  
Zhiyuan Xu ◽  
Yian Du ◽  
Ping Hu ◽  
Guofa Yu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Target Therapy ◽  
Performance Status ◽  
R0 Resection ◽  
Conversion Therapy ◽  
Efficacy Evaluation ◽  
Related Complication ◽  
Open Label ◽  
Unresectable Gastric Cancer

53 Background: Occasionally, an initially unresectable gastric cancer (GC) can be converted to a resectable one by chemotherapy. Combination with inhibitors against VEGFR-2 can lead to a clinical improvement. We aimed to investigate the efficacy and safety of S1/paclitaxel chemotherapy plus apatinib, a novel inhibitor of VEGFR-2, in the conversion therapy of unresectable GC. Methods: This was a multicentre, single-arm, open-label, phase II design. Eligible patients (pts) were aged 20-70 years and had histologically proven unresectable, HER-2 negative, advanced GC with a single non-curable factor confined to either the liver (H1), peritoneum (P1), or para-aortic lymph nodes (16a1/b2). The ECOG performance status was 0-2. No prior radiotherapy, chemotherapy, target therapy or immunotherapy was allowed. Patients received 2 cycles of S1/paclitaxel chemotherapy (S1: 60 mg, oral, bid for 2 weeks followed by a drug-free interval of 1 week; paclitaxel: 150 mg/m2, iv, 3h, on day 1) plus apatinib (500 mg, oral, qd) and 1 cycle of S1/paclitaxel chemotherapy prior to radical surgery. Three cycles of adjuvant chemotherapy (S1 and apatinib) were given 4-6 weeks after surgery. Primary endpoint was R0 resection rate. Thirty-three pts were enrolled. Results: Among the 28 pts eligible for preoperative efficacy evaluation, 21 achieved partial response (PR), 5 had stable disease (SD), and 2 had progressive disease (PD), resulting in an overall response rate of 75.0% and a disease control rate of 92.9%. Of the 21 pts with PR, 3 refused consents for surgery and 18 achieved R0 resection. The incidence of adverse events (AEs) was 73.9%. The common hematologic AEs were neutropenia (60.9%), leukopenia (52.2%) and hemoglobin decrease (47.8%), and nonhematologic AEs included hyperbilirubinemia (56.5%), hand-foot syndrome (34.8%), oral mucositis (30.4%), fatigue (30.4%), proteinuria (21.7%) and hypocalcemia (21.7%). There was no severe surgery-related complication. Conclusions: Combination of apatinib with S1/paclitaxel chemotherapy shows clinical benefits in unresectable GC, with acceptable safety profile. Clinical trial information: NCT02529878.

scholarly journals Short-Term Survival and Safety of Apatinib Combined With Oxaliplatin and S-1 in the Conversion Therapy of Unresectable Gastric Cancer

2021 ◽  
Author(s):  
Zaisheng Ye ◽  
Yi Zeng ◽  
Shenghong Wei ◽  
Yi Wang ◽  
Zhitao Lin ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Survival Rate ◽  
Objective Response ◽  
Radical Resection ◽  
R0 Resection ◽  
Conversion Therapy ◽  
Short Term ◽  
Term Survival ◽  
Unresectable Gastric Cancer ◽  
Short Term Survival

Abstract BackgroundTo investigate the short-term efficacy and safety of apatinib combined with oxaliplatin and S-1 in the treatment of unresectable gastric cancer.Patients and methodsPreviously untreated patients with unresectable HER-2-negative advanced gastric cancer were selected. All the patients received six cycles of S-1 and oxaliplatin and five cycles of apatinib, which were administered at intervals of three weeks. The surgery was performed after six cycles of drug treatment. The primary endpoints were radical resection (R0) rate and safety. This study was registered with the China Trial Register, number ChiCTR-ONC-17010430(01/12/2016-01/12/2022).ResultsA total of 39 patients were enrolled. Efficacy evaluation was feasible for 37 patients. One patient achieved complete response (CR, 2.7%), 26 patients achieved partial response (PR, 70.3%), three patients had stable disease (SD, 8.1%) and seven patients had progressive disease (PD, 18.9%). The objective response rate (ORR) was 73.0% and the disease control rate (DCR) was 81.1%. 22 patients underwent surgery, among which 14 patients underwent radical resection (R0), with a R0 resection rate of 63.6%. The 1-year survival rate of the surgical group (22 patients) was 71.1% and the 2-year survival rate was 41.1%. The median survival time was 21 months. The incidence of adverse reactions (AEs) was 100%. Leucopenia (65.3%) and granulocytopenia (69.2%) were the most common hematological AEs. The most common non-hematological AEs were fatigue (51.3%) and oral mucositis (35.9%).ConclusionApatinib combined with oxaliplatin and S-1 showed good short-term survival and acceptable safety in the conversion therapy of unresectable gastric cancer.

scholarly journals Efficacy of Conversion Surgery Following Apatinib Plus Paclitaxel/S1 for Advanced Gastric Cancer With Unresectable Factors: A Multicenter, Single-Arm, Phase II Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Zhiyuan Xu ◽  
Can Hu ◽  
Jianfa Yu ◽  
Yian Du ◽  
Ping Hu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Objective Response ◽  
Bleeding Event ◽  
Primary Objective ◽  
R0 Resection ◽  
Preoperative Treatment ◽  
Conversion Surgery ◽  
Response To Chemotherapy ◽  
Unresectable Gastric Cancer ◽  
Grade 3

Objective: Conversion therapy (surgical resection after chemotherapy) is a promising option for unresectable gastric cancer (GC) patients. Addition of anti-angiogenesis drug improves response to chemotherapy. Hence, this study explored the feasibility and efficacy of preoperative paclitaxel (PTX)/S1 chemotherapy combined with apatinib for unresectable GC.Methods: Thirty-one eligible patients with a single unresectable factor were enrolled in this multi-center, single-arm trial. Apatinib (500 mg qd) was administered continuously, while PTX (130 mg/m2) on day 1 and S1 (80 mg/m2) on day 1–14 were given every 3 weeks. The treatment was given for three cycles preoperatively, but the last cycle did not include apatinib. The primary objective measurements included R0 resection rate, objective response rate (ORR) and morbidity of preoperative treatment.Results: Among the 31 patients, 30 patients were evaluable for tumor response, the ORR to preoperative treatment was 73.3%. Eighteen of 30 patients underwent surgery, and R0 resection was achieved in 17 patients. The patients who underwent the conversion surgery had a superior OS compared with those who did not (3 years OS: 52.9 vs 8.3%, p = 0.001). The surgery was operated after apatinib had stopped for a median duration of 4 weeks. Neither anastomotic leakage nor wound healing complications was observed. No increased bleeding event was observed compared with historical data. During preoperative treatment, grade 3 or 4 toxicities were experienced by 58.1% of the patients.Conclusion: Chemotherapy in combination with apatinib demonstrated higher rates of conversion and R0 resection and a superior survival benefit in initial unresectable GC. It is safe and reasonable to suspend apatinib for 4 weeks before the gastrectomy.

scholarly journals The Results of Conversion Therapy for Initially Unresectable Gastric Cancer: a Respective Analysis of 191 Patients

2021 ◽  
Author(s):  
Shaopeng Zhang ◽  
Song Wu ◽  
Yuan Kong ◽  
Wei Li
Keyword(s):  
Gastric Cancer ◽  
Prognostic Factors ◽  
Surgical Treatment ◽  
Systemic Chemotherapy ◽  
R0 Resection ◽  
Conversion Therapy ◽  
Response To Chemotherapy ◽  
Unresectable Gastric Cancer ◽  
N Stage ◽  
Intraperitoneal Hyperthermic Perfusion

Abstract 【Objective】 To analyze the clinical efficacy of systemic chemotherapy combined with intraperitoneal hyperthermic perfusion in the treatment of locally invasive stage III gastric cancer and stage IV gastric cancer. 【Methods】 The clinical data of 191 patients with gastric cancer who received systemic chemotherapy combined with intraperitoneal hyperthermic perfusion from June 2010 to December 2018 were retrospectively analyzed. 【Results】 The unresectable factors in 191 patients with gastric cancer included peritoneum metastasis (106), local invasion (67), liver metastasis (25), lung metastasis (3), bone metastasis (4), adnexal metastasis (3) and adrenal metastasis (4). After conversion therapy, 191 patients were divided into finished conversion group and non-finished group. There were significant differences in T stage, M stage and tumor differentiation between the two groups. During the course of chemotherapy, 11 patients had grade 3 or 4 chemotherapy adverse reactions. The median survival was 36 months in the finished conversion group and 14 months in the non-finished group. The median survival of the 69 R0 resected patients was 38 months, which was higher than that of chemotherapy alone (14 months), best supportive care (13 months) and patients who completed chemotherapy without R0 resection (19 months). Univariate Cox survival analysis found that N stage, R0 resection, response to chemotherapy and unresectable factors were prognostic factors. Multivariate Cox survival analysis showed that N-stage, response to chemotherapy and unresectable factors were independent prognostic factors. 【 Conclusion 】 For unresectable gastric cancer patients, surgical treatment after chemotherapy can prolong survival. Radical surgical treatment after conversion therapy and chemotherapy response are important factors related to patient survival. Chemotherapy alone can prolong survival in primary unresectable gastric cancer, but with limited effect.

scholarly journals Short-term survival and safety of apatinib combined with oxaliplatin and S-1 in the conversion therapy of unresectable gastric cancer

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zaisheng Ye ◽  
Yi Zeng ◽  
Shenghong Wei ◽  
Yi Wang ◽  
Zhitao Lin ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Survival Rate ◽  
Objective Response ◽  
Radical Resection ◽  
R0 Resection ◽  
Conversion Therapy ◽  
Short Term ◽  
Term Survival ◽  
Unresectable Gastric Cancer ◽  
Short Term Survival

Abstract Background We conducted a single-arm phase II trial to investigate the short-term efficacy and safety of apatinib combined with oxaliplatin and S-1 in the treatment of unresectable gastric cancer. Patients and methods Previously untreated patients with unresectable HER-2-negative advanced gastric cancer were selected. All the patients received six cycles of S-1 and oxaliplatin and five cycles of apatinib, which were administered at intervals of three weeks. The surgery was performed after six cycles of drug treatment. The primary endpoints were radical resection (R0) rate and safety. This study was registered with the China Trial Register, number ChiCTR-ONC-17010430 (01/12/2016–01/12/2022). Results A total of 39 patients were enrolled. Efficacy evaluation was feasible for 37 patients. One patient achieved complete response (CR, 2.7%), 26 patients achieved partial response (PR, 70.3%), three patients had stable disease (SD, 8.1%) and seven patients had progressive disease (PD, 18.9%). The objective response rate (ORR) was 73.0% and the disease control rate (DCR) was 81.1%. 22 patients underwent surgery, among which 14 patients underwent radical resection (R0), with a R0 resection rate of 63.6%. The 1-year survival rate of the surgical group (22 patients) was 71.1% and the 2-year survival rate was 41.1%. The median survival time was 21 months. The incidence of adverse events (AEs) was 100%. Leucopenia (65.3%) and granulocytopenia (69.2%) were the most common hematological AEs. The most common non-hematological AEs were fatigue (51.3%) and oral mucositis (35.9%). Conclusion Apatinib combined with oxaliplatin and S-1 showed good short-term survival and acceptable safety in the conversion therapy of unresectable gastric cancer.

scholarly journals Colorectal Endoscopic Submucosal Dissection in a Western Center: Analysis of Outcomes and Safety Profile

2021 ◽  
pp. 1-9
Author(s):  
João Santos-Antunes ◽  
Margarida Marques ◽  
Rui Morais ◽  
Fátima Carneiro ◽  
Guilherme Macedo
Keyword(s):  
Endoscopic Submucosal Dissection ◽  
Safety Profile ◽  
En Bloc Resection ◽  
R0 Resection ◽  
Hybrid Technique ◽  
Resection Rate ◽  
En Bloc ◽  
Delayed Bleeding ◽  
Submucosal Dissection ◽  
Gastrointestinal Lesions

<b><i>Introduction:</i></b> Endoscopic submucosal dissection (ESD) is a well-established endoscopic technique for the treatment of gastrointestinal lesions. Colorectal ESD outcomes are less reported in the Western literature, and Portuguese data are still very scarce. Our aim was to describe our experience on colorectal ESD regarding its outcomes and safety profile. <b><i>Methods:</i></b> We conducted a retrospective evaluation of recorded data on ESDs performed between 2015 and 2020. Only ESDs performed on epithelial neoplastic lesions were selected for further analysis. <b><i>Results:</i></b> Of a total of 167 colorectal ESDs, 153 were included. Technical success was achieved in 147 procedures (96%). The lesions were located in the colon (<i>n</i> = 24) and rectum (<i>n</i> = 123). The en bloc resection rate was 92% and 97%, the R0 resection rate was 83% and 82%, and the curative resection rate was 79% and 78% for the colon and the rectum, respectively. The need for a hybrid technique was the only risk factor for piecemeal or R1 resection. We report a perforation rate of 3.4% and a 4.1% rate of delayed bleeding; all the adverse events were manageable endoscopically, without the need of blood transfusions or surgery. Most of the lesions were laterally spreading tumours of the granular mixed type (70%), and 20% of the lesions were malignant (12% submucosal and 8% intramucosal cancer). <b><i>Conclusion:</i></b> Our series on colorectal ESD reports a very good efficacy and safety profile. This technique can be applied by endoscopists experienced in ESD.

Neoadjuvant chemoradiotherapy plus postoperative adjuvant XELOX chemotherapy versus postoperative adjuvant chemotherapy with XELOX regimen for local advanced gastric cancer-A randomized, controlled study

2021 ◽  
pp. 20201088
Author(s):  
Fuli Wang ◽  
Aizhong Qu ◽  
Yinping Sun ◽  
Jifeng Zhang ◽  
Benzun Wei ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Postoperative Complications ◽  
Advanced Gastric Cancer ◽  
Neoadjuvant Chemoradiotherapy ◽  
Regional Recurrence ◽  
R0 Resection ◽  
Resection Rate ◽  
Postoperative Adjuvant Chemotherapy ◽  
Local Advanced

Objective: The aim of this study was to compare the clinical efficacy of neoadjuvant chemoradiotherapy (NACRT) combined with postoperative adjuvant XELOX (Oxaliplatin +Capecitabine) chemotherapy and postoperative adjuvant chemotherapy (ACT) with XELOX for local advanced gastric cancer (LAGC). Methods: In this prospectively randomized trial, we investigated the effect of NACRT combined with postoperative ACT for LAGC. 60 patients were randomly divided into NACRT group and ACT group, with 30 patients in each group. Patients in NACRT group were given three-dimensional conformal radiotherapy (45 Gy/1.8 Gy/f) accompanied by synchronous XELOX of two cycles, followed by surgery, and then postoperative adjuvant XELOX chemotherapy of four cycles was performed. Patients in ACT group received surgery in advance, and then XELOX chemotherapy of six cycles was given. Results: The objective response rate of NACRT was 76.7%. The overall incidence of postoperative complications in NACRT group was not significantly different from that in ACT group (23.1% vs 30.0%, p = 0.560). The 1 year, 2 years, and 3 years progression-free survival (PFS）and overall survival (OS) in NACRT and ACT groups were 80.0% vs 56.7%, 73.3% vs 46.7%, 60.0% vs 33.3%, and 86.7% vs 80.0%, 76.7% vs 66.7%, 63.3% vs 50.0%, respectively. Patients in NACRT group showed a significantly higher R0 resection rate (84.6% vs 56.7%, p = 0.029),lower loco-regional recurrence rate (36.7% vs 11.5%, p = 0.039), longer PFS (p = 0.019) and freedom from locoregional progression(FFLP) (p = 0.004) than patients in ACT group, while there was no difference in OS (p = 0.215) and in toxicity incidence (p > 0.05). Conclusions: NACRT combined with postoperative adjuvant XELOX chemotherapy can improve R0 resection rate, reduce loco-regional recurrence, prolong PFS and FFLP without increasing the incidence of postoperative complications in patients with LAGC. Advances in knowledge: Compared with postoperative adjuvant chemotherapy, locally advanced gastric cancer patients may benefit from neoadjuvant chemoradiotherapy, and toxicity associated with chemoradiotherapy was tolerant and manageable.

scholarly journals Neoadjuvant Chemotherapy Compared With Surgery Alone for Locally Advanced Cancer of the Stomach and Cardia: European Organisation for Research and Treatment of Cancer Randomized Trial 40954

2010 ◽  
Vol 28 (35) ◽  
pp. 5210-5218 ◽  
Author(s):  
Christoph Schuhmacher ◽  
Stephan Gretschel ◽  
Florian Lordick ◽  
Peter Reichardt ◽  
Werner Hohenberger ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Neoadjuvant Chemotherapy ◽  
Preoperative Chemotherapy ◽  
Survival Benefit ◽  
Locally Advanced ◽  
Postoperative Chemotherapy ◽  
Phase Iii ◽  
R0 Resection ◽  
Resection Rate

PurposePatients with locally advanced gastric cancer benefit from combined pre- and postoperative chemotherapy, although fewer than 50% could receive postoperative chemotherapy. We examined the value of purely preoperative chemotherapy in a phase III trial with strict preoperative staging and surgical resection guidelines.Patients and MethodsPatients with locally advanced adenocarcinoma of the stomach or esophagogastric junction (AEG II and III) were randomly assigned to preoperative chemotherapy followed by surgery or to surgery alone. To detect with 80% power an improvement in median survival from 17 months with surgery alone to 24 months with neoadjuvant, 282 events were required.ResultsThis trial was stopped for poor accrual after 144 patients were randomly assigned (72:72); 52.8% patients had tumors located in the proximal third of the stomach, including AEG type II and III. The International Union Against Cancer R0 resection rate was 81.9% after neoadjuvant chemotherapy as compared with 66.7% with surgery alone (P = .036). The surgery-only group had more lymph node metastases than the neoadjuvant group (76.5% v 61.4%; P = .018). Postoperative complications were more frequent in the neoadjuvant arm (27.1% v 16.2%; P = .09). After a median follow-up of 4.4 years and 67 deaths, a survival benefit could not be shown (hazard ratio, 0.84; 95% CI, 0.52 to 1.35; P = .466).ConclusionThis trial showed a significantly increased R0 resection rate but failed to demonstrate a survival benefit. Possible explanations are low statistical power, a high rate of proximal gastric cancer including AEG and/or a better outcome than expected after radical surgery alone due to the high quality of surgery with resections of regional lymph nodes outside the perigastic area (celiac trunc, hepatic ligament, lymph node at a. lienalis; D2).

A multinational phase II clinical trial of neoadjuvant imatinib for large gastrointestinal stromal tumor of the stomach.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 130-130
Author(s):  
Han-Kwang Yang ◽  
Yukinori Kurokawa ◽  
Min-Hee Ryu ◽  
Haruhiko Cho ◽  
Sook Ryun Park ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Gastrointestinal Stromal Tumor ◽  
Neoadjuvant Treatment ◽  
Stromal Tumor ◽  
Maximal Response ◽  
R0 Resection ◽  
Gastric Gist ◽  
Efficacy And Safety ◽  
Resection Rate

130 Background: Neoadjuvant therapy is expected to reduce the risk of primary surgery, such as rupture of the tumor, hemorrhage, and multi-visceral resection, and to improve survivals for patients with a large gastric gastrointestinal stromal tumor (GIST). This study aims to evaluate the efficacy and safety of neoadjuvant imatinib therapy for a large gastric GIST. Methods: Patients with gastric GIST, which is 10cm or larger and without metastasis, received neoadjuvant imatinib (400mg/day) for 6 months, and up to 9 months if maximal response is expected. Postoperative adjuvant imatinib was prescribed for at least 1 year and up to 3 years according to adjuvant treatment guideline. The primary endpoint was complete (R0) resection rate. A primary analysis were performed by the time all the operations were finished, to examine the efficacy and safety of the neoadjuvant treatment. Results: Between Feb 2010 and Sep 2014, 55 patients were enrolled in Japan and Korea. One patient with a jejunal GIST and one patient with PDGFRA-18 D842V mutation were excluded from analysis. Mean tumor diameter was 12cm (10-23). 86.8% of patients (46/53) completed neoadjuvant treatment. Dose reduction of imatinib was performed in 26.4% (14/53). The most frequent Grade 3 or 4 adverse events were G3 rash (5/53, 9.4%) and G3/4 neutropenia (4/53, 7.5%). Disease control rate (PR+SD) and response rate (PR) of neoadjuvant imatinib was 100% and 62.3% by RECIST, and 100% and 98.1% by Choi criteria, respectively. There was no case of CR or PD. 50 patients underwent operation, and R0 resection rate was 90.6% (n = 48, 95% CI 79.3% - 96.9%), which was significantly higher than the threshold value of 70% (p < 0.001). Combined resection of other organs (except gall bladder) was performed in 24.5% (n = 13), and 83.0% of patients (n = 44) could preserve ≥ 50% of the stomach. Postoperative complication occurred in 18.0% (9/50). Conclusions: Neoadjuvant imatinib treatment is effective and safe treatment option for a large primary GIST allowing high R0 resection rate with acceptable incidence of adverse events and postoperative complications. Clinical trial information: UMIN000003114.

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