Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT06490159
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2024-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer
Sponsor:
Organization:
Raw JSON
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Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.'}, {'pmid': '35130500', 'type': 'BACKGROUND', 'citation': "Ajani JA, D'Amico TA, Bentrem DJ, Chao J, Cooke D, Corvera C, Das P, Enzinger PC, Enzler T, Fanta P, Farjah F, Gerdes H, Gibson MK, Hochwald S, Hofstetter WL, Ilson DH, Keswani RN, Kim S, Kleinberg LR, Klempner SJ, Lacy J, Ly QP, Matkowskyj KA, McNamara M, Mulcahy MF, Outlaw D, Park H, Perry KA, Pimiento J, Poultsides GA, Reznik S, Roses RE, Strong VE, Su S, Wang HL, Wiesner G, Willett CG, Yakoub D, Yoon H, McMillian N, Pluchino LA. Gastric Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Feb;20(2):167-192. doi: 10.6004/jnccn.2022.0008."}, {'pmid': '28711577', 'type': 'BACKGROUND', 'citation': 'Park SR, Kim MJ, Nam BH, Kim CG, Lee JY, Cho SJ, Kong SY, Park YI. A randomised phase II study of continuous versus stop-and-go S-1 plus oxaliplatin following disease stabilisation in first-line chemotherapy in patients with metastatic gastric cancer. Eur J Cancer. 2017 Sep;83:32-42. doi: 10.1016/j.ejca.2017.06.008. Epub 2017 Jul 14.'}, {'pmid': '37068504', 'type': 'BACKGROUND', 'citation': 'Shitara K, Lordick F, Bang YJ, Enzinger P, Ilson D, Shah MA, Van Cutsem E, Xu RH, Aprile G, Xu J, Chao J, Pazo-Cid R, Kang YK, Yang J, Moran D, Bhattacharya P, Arozullah A, Park JW, Oh M, Ajani JA. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023 May 20;401(10389):1655-1668. doi: 10.1016/S0140-6736(23)00620-7. Epub 2023 Apr 15.'}, {'pmid': '35724467', 'type': 'BACKGROUND', 'citation': 'Zhang J, Gao HF, Yang C, Zhu T, Ji F, Yang M, Zhang L, Li J, Cheng M, Zhang T, Shen B, Chen Y, Wang K. Prevention of taxane-associated acute pain syndrome with etoricoxib for patients with breast cancer: A phase II randomised trial. Eur J Cancer. 2022 Aug;171:150-160. doi: 10.1016/j.ejca.2022.05.019. Epub 2022 Jun 17.'}, {'pmid': '32532230', 'type': 'BACKGROUND', 'citation': 'Hirata K, Hamamoto Y, Ando M, Imamura CK, Yoshimura K, Yamazaki K, Hironaka S, Muro K. Weekly paclitaxel plus ramucirumab versus weekly nab-paclitaxel plus ramucirumab for unresectable advanced or recurrent gastric cancer with peritoneal dissemination refractory to first-line therapy-the P-SELECT trial (WJOG10617G)-a randomised phase II trial by the West Japan Oncology Group. BMC Cancer. 2020 Jun 12;20(1):548. doi: 10.1186/s12885-020-07047-1.'}, {'pmid': '21128110', 'type': 'BACKGROUND', 'citation': 'Hershman DL, Weimer LH, Wang A, Kranwinkel G, Brafman L, Fuentes D, Awad D, Crew KD. Association between patient reported outcomes and quantitative sensory tests for measuring long-term neurotoxicity in breast cancer survivors treated with adjuvant paclitaxel chemotherapy. Breast Cancer Res Treat. 2011 Feb;125(3):767-74. doi: 10.1007/s10549-010-1278-0. Epub 2010 Dec 3.'}, {'pmid': '36322088', 'type': 'BACKGROUND', 'citation': 'Mo H, Yan X, Zhao F, Teng Y, Sun X, Lv Z, Cao M, Zhao J, Song G, Pan B, Li H, Zhai J, Xu B, Ma F. Association of Taxane Type With Patient-Reported Chemotherapy-Induced Peripheral Neuropathy Among Patients With Breast Cancer. JAMA Netw Open. 2022 Nov 1;5(11):e2239788. doi: 10.1001/jamanetworkopen.2022.39788.'}, {'pmid': '24733808', 'type': 'BACKGROUND', 'citation': 'Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.'}, {'pmid': '34340206', 'type': 'BACKGROUND', 'citation': 'Battaglini E, Goldstein D, Grimison P, McCullough S, Mendoza-Jones P, Park SB. Chemotherapy-Induced Peripheral Neurotoxicity in Cancer Survivors: Predictors of Long-Term Patient Outcomes. J Natl Compr Canc Netw. 2021 Jul 28;19(7):821-828. doi: 10.6004/jnccn.2021.7026.'}, {'pmid': '36627698', 'type': 'BACKGROUND', 'citation': 'Ma S, Zhou M, Xu Y, Gu X, Zou M, Abudushalamu G, Yao Y, Fan X, Wu G. Clinical application and detection techniques of liquid biopsy in gastric cancer. Mol Cancer. 2023 Jan 11;22(1):7. doi: 10.1186/s12943-023-01715-z.'}, {'pmid': '37972701', 'type': 'BACKGROUND', 'citation': 'Zhou X, Jia Y, Mao C, Liu S. Small extracellular vesicles: Non-negligible vesicles in tumor progression, diagnosis, and therapy. Cancer Lett. 2024 Jan 1;580:216481. doi: 10.1016/j.canlet.2023.216481. Epub 2023 Nov 15.'}, {'pmid': '26892862', 'type': 'BACKGROUND', 'citation': 'Tovar-Camargo OA, Toden S, Goel A. Exosomal microRNA Biomarkers: Emerging Frontiers in Colorectal and Other Human Cancers. Expert Rev Mol Diagn. 2016;16(5):553-67. doi: 10.1586/14737159.2016.1156535. Epub 2016 Mar 16.'}, {'pmid': '27596437', 'type': 'BACKGROUND', 'citation': 'Balusu S, Van Wonterghem E, De Rycke R, Raemdonck K, Stremersch S, Gevaert K, Brkic M, Demeestere D, Vanhooren V, Hendrix A, Libert C, Vandenbroucke RE. Identification of a novel mechanism of blood-brain communication during peripheral inflammation via choroid plexus-derived extracellular vesicles. EMBO Mol Med. 2016 Oct 4;8(10):1162-1183. doi: 10.15252/emmm.201606271. Print 2016 Oct.'}, {'pmid': '33548389', 'type': 'BACKGROUND', 'citation': 'Yu W, Hurley J, Roberts D, Chakrabortty SK, Enderle D, Noerholm M, Breakefield XO, Skog JK. Exosome-based liquid biopsies in cancer: opportunities and challenges. Ann Oncol. 2021 Apr;32(4):466-477. doi: 10.1016/j.annonc.2021.01.074. Epub 2021 Feb 4.'}, {'pmid': '28143873', 'type': 'BACKGROUND', 'citation': 'Shigeyasu K, Toden S, Zumwalt TJ, Okugawa Y, Goel A. Emerging Role of MicroRNAs as Liquid Biopsy Biomarkers in Gastrointestinal Cancers. Clin Cancer Res. 2017 May 15;23(10):2391-2399. doi: 10.1158/1078-0432.CCR-16-1676. Epub 2017 Jan 31.'}, {'pmid': '31900466', 'type': 'BACKGROUND', 'citation': 'Jung G, Hernandez-Illan E, Moreira L, Balaguer F, Goel A. Epigenetics of colorectal cancer: biomarker and therapeutic potential. Nat Rev Gastroenterol Hepatol. 2020 Feb;17(2):111-130. doi: 10.1038/s41575-019-0230-y. Epub 2020 Jan 3.'}, {'pmid': '31604467', 'type': 'BACKGROUND', 'citation': 'Tanioka H, Nagasaka T, Uno F, Inoue M, Okita H, Katata Y, Kanzaki H, Kuramochi H, Satake H, Shindo Y, Doi A, Nasu J, Yamashita H, Yamaguchi Y. The relationship between peripheral neuropathy and efficacy in second-line chemotherapy for unresectable advanced gastric cancer: a prospective observational multicenter study protocol (IVY). BMC Cancer. 2019 Oct 11;19(1):941. doi: 10.1186/s12885-019-6163-6.'}, {'pmid': '28404157', 'type': 'BACKGROUND', 'citation': 'Shitara K, Takashima A, Fujitani K, Koeda K, Hara H, Nakayama N, Hironaka S, Nishikawa K, Makari Y, Amagai K, Ueda S, Yoshida K, Shimodaira H, Nishina T, Tsuda M, Kurokawa Y, Tamura T, Sasaki Y, Morita S, Koizumi W. Nab-paclitaxel versus solvent-based paclitaxel in patients with previously treated advanced gastric cancer (ABSOLUTE): an open-label, randomised, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):277-287. doi: 10.1016/S2468-1253(16)30219-9. Epub 2017 Jan 19.'}, {'pmid': '29353164', 'type': 'BACKGROUND', 'citation': 'Bando H, Shimodaira H, Fujitani K, Takashima A, Yamaguchi K, Nakayama N, Takahashi T, Oki E, Azuma M, Nishina T, Hironaka S, Komatsu Y, Shitara K. A phase II study of nab-paclitaxel in combination with ramucirumab in patients with previously treated advanced gastric cancer. Eur J Cancer. 2018 Mar;91:86-91. doi: 10.1016/j.ejca.2017.11.032. Epub 2018 Jan 30.'}, {'pmid': '34626550', 'type': 'BACKGROUND', 'citation': 'Xu RH, Zhang Y, Pan H, Feng J, Zhang T, Liu T, Qin Y, Qin S, Yin X, Liu B, Ba Y, Yang N, Voon PJ, Tanasanvimon S, Zhou C, Zhang WL, Shen L. Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): a randomised, multicentre, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Dec;6(12):1015-1024. doi: 10.1016/S2468-1253(21)00313-7. Epub 2021 Oct 7.'}, {'pmid': '37713657', 'type': 'BACKGROUND', 'citation': 'Moehler M, Xiao H, Blum SI, Elimova E, Cella D, Shitara K, Ajani JA, Janjigian YY, Garrido M, Shen L, Yamaguchi K, Liu T, Schenker M, Kowalyszyn R, Bragagnoli AC, Bruges R, Montesarchio V, Pazo-Cid R, Hunter S, Davenport E, Wang J, Kondo K, Li M, Wyrwicz L. Health-Related Quality of Life With Nivolumab Plus Chemotherapy Versus Chemotherapy in Patients With Advanced Gastric/Gastroesophageal Junction Cancer or Esophageal Adenocarcinoma From CheckMate 649. J Clin Oncol. 2023 Dec 10;41(35):5388-5399. doi: 10.1200/JCO.23.00170. Epub 2023 Sep 15.'}, {'pmid': '24094768', 'type': 'BACKGROUND', 'citation': 'Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3.'}, {'pmid': '35030335', 'type': 'BACKGROUND', 'citation': 'Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, Lee KW, Omori T, Shitara K, Sakuramoto S, Chung IJ, Yamaguchi K, Kato K, Sym SJ, Kadowaki S, Tsuji K, Chen JS, Bai LY, Oh SY, Choda Y, Yasui H, Takeuchi K, Hirashima Y, Hagihara S, Boku N. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):234-247. doi: 10.1016/S1470-2045(21)00692-6. Epub 2022 Jan 11.'}, {'pmid': '24190112', 'type': 'BACKGROUND', 'citation': 'Hironaka S, Ueda S, Yasui H, Nishina T, Tsuda M, Tsumura T, Sugimoto N, Shimodaira H, Tokunaga S, Moriwaki T, Esaki T, Nagase M, Fujitani K, Yamaguchi K, Ura T, Hamamoto Y, Morita S, Okamoto I, Boku N, Hyodo I. Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 4007 trial. J Clin Oncol. 2013 Dec 10;31(35):4438-44. doi: 10.1200/JCO.2012.48.5805. Epub 2013 Nov 4.'}, {'pmid': '30355453', 'type': 'BACKGROUND', 'citation': 'Shitara K, Doi T, Dvorkin M, Mansoor W, Arkenau HT, Prokharau A, Alsina M, Ghidini M, Faustino C, Gorbunova V, Zhavrid E, Nishikawa K, Hosokawa A, Yalcin S, Fujitani K, Beretta GD, Cutsem EV, Winkler RE, Makris L, Ilson DH, Tabernero J. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1437-1448. doi: 10.1016/S1470-2045(18)30739-3. Epub 2018 Oct 21.'}, {'pmid': '32469182', 'type': 'BACKGROUND', 'citation': 'Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. doi: 10.1056/NEJMoa2004413. Epub 2020 May 29.'}, {'pmid': '12204664', 'type': 'BACKGROUND', 'citation': 'Cavaletti G, Zanna C. Current status and future prospects for the treatment of chemotherapy-induced peripheral neurotoxicity. Eur J Cancer. 2002 Sep;38(14):1832-7. doi: 10.1016/s0959-8049(02)00229-0. No abstract available.'}, {'pmid': '29117336', 'type': 'BACKGROUND', 'citation': 'Park SB, Kwok JB, Asher R, Lee CK, Beale P, Selle F, Friedlander M. Clinical and genetic predictors of paclitaxel neurotoxicity based on patient- versus clinician-reported incidence and severity of neurotoxicity in the ICON7 trial. Ann Oncol. 2017 Nov 1;28(11):2733-2740. doi: 10.1093/annonc/mdx491.'}, {'pmid': '32333051', 'type': 'BACKGROUND', 'citation': 'Meregalli C, Fumagalli G, Alberti P, Canta A, Chiorazzi A, Monza L, Pozzi E, Carozzi VA, Blennow K, Zetterberg H, Cavaletti G, Marmiroli P. Neurofilament light chain: a specific serum biomarker of axonal damage severity in rat models of Chemotherapy-Induced Peripheral Neurotoxicity. Arch Toxicol. 2020 Jul;94(7):2517-2522. doi: 10.1007/s00204-020-02755-w. Epub 2020 Apr 24.'}, {'pmid': '28677679', 'type': 'BACKGROUND', 'citation': 'Sakai A, Saitow F, Maruyama M, Miyake N, Miyake K, Shimada T, Okada T, Suzuki H. MicroRNA cluster miR-17-92 regulates multiple functionally related voltage-gated potassium channels in chronic neuropathic pain. Nat Commun. 2017 Jul 5;8:16079. doi: 10.1038/ncomms16079.'}, {'pmid': '27381812', 'type': 'BACKGROUND', 'citation': 'Yi S, Yuan Y, Chen Q, Wang X, Gong L, Liu J, Gu X, Li S. Regulation of Schwann cell proliferation and migration by miR-1 targeting brain-derived neurotrophic factor after peripheral nerve injury. Sci Rep. 2016 Jul 6;6:29121. doi: 10.1038/srep29121.'}, {'pmid': '36972359', 'type': 'BACKGROUND', 'citation': 'Zhi WI, Dreyfus N, Lessing A, Galantino M, Piulson L, Kot KL, Li S, Bao T. Patient Characteristics Associated With Chemotherapy-Induced Peripheral Neuropathy Severity in a Phase II Clinical Trial: A Retrospective Analysis. Oncologist. 2023 Jul 5;28(7):604-608. doi: 10.1093/oncolo/oyad062.'}, {'pmid': '27794123', 'type': 'BACKGROUND', 'citation': 'Greenlee H, Hershman DL, Shi Z, Kwan ML, Ergas IJ, Roh JM, Kushi LH. BMI, Lifestyle Factors and Taxane-Induced Neuropathy in Breast Cancer Patients: The Pathways Study. J Natl Cancer Inst. 2016 Oct 28;109(2):djw206. doi: 10.1093/jnci/djw206. Print 2017 Feb.'}, {'pmid': '36367997', 'type': 'BACKGROUND', 'citation': "Lee S, Ma C, Shi Q, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Lewis D, Tan B, Goldberg RM, Venook A, Blanke C, O'Reilly EM, Shields AF, Meyerhardt JA. Potential Mediators of Oxaliplatin-Induced Peripheral Neuropathy From Adjuvant Therapy in Stage III Colon Cancer: Findings From CALGB (Alliance)/SWOG 80702. J Clin Oncol. 2023 Feb 10;41(5):1079-1091. doi: 10.1200/JCO.22.01637. Epub 2022 Nov 11."}]}, 'descriptionModule': {'briefSummary': 'Although advances in chemotherapy have improved the prognosis of gastric cancer patients, many patients still suffer from adverse events. Therefore, it is necessary to establish personalized treatment by identifying patients at high risk for side effects. Although paclitaxel-based therapy is the standard second-line treatment, peripheral neuropathy is a troublesome adverse event. The purpose of this study is to establish a liquid biopsy assay to predict paclitaxel-induced peripheral neuropathy in gastric cancer patients.', 'detailedDescription': 'Paclitaxel-based therapy is the standard second-line treatment for gastric cancer patients, but approximately 30-40% of patients develop peripheral neuropathy that interferes with daily life, and about 10% develop severe grade 3 peripheral neuropathy. Particularly severe side effects can cause patients to lose strength, forcing them to discontinue treatment, and thus losing the opportunity to receive other treatments that were originally expected to have a therapeutic effect. This study aims to predict peripheral neuropathy in the side effects of second-line treatment (paclitaxel plus ramucirumab) in patients with gastric cancer using liquid biopsies (small RNA). If patients at high risk for side effects can be predicted prior to treatment, high-risk patients can be offered drug reductions or other chemotherapy options. The aim of this study is to predict peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer by liquid biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients need second-line chemotherapy with unresectable or recurrent Gastric cancer.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. unresectable or recurrent Gastric cancer (GC) histologically confirmed to be primary adenocarcinoma of the stomach.\n2. age over 20 years.\n3. Eastern Cooperative Oncology Group performance status score of 0-2.\n4. written informed consent following full study information is provided to the patient.\n5. progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC.\n6. presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging.\n\nExclusion Criteria:\n\n1. Patients with a life expectancy of shorter than 3 months\n2. Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency.\n3. Patients with a history of serious allergic reactions or serious drug allergy.\n4. Patients with a clinically relevant mental disorder that prohibits response to questionnaires.\n5. Patients for whom the attending physician considered that enrollment in the study is inappropriate.'}, 'identificationModule': {'nctId': 'NCT06490159', 'briefTitle': 'Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Predicting Peripheral Neuropathy of Paclitaxel in Second-line Chemotherapy for Gastric Cancer', 'orgStudyIdInfo': {'id': '23228/SLCGC-AE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer', 'description': 'A panel of microRNA, whose expression level is tested exosomal microRNA from blood sample before second-line chemotherapy with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)', 'interventionNames': ['Drug: Paclitaxel']}, {'label': 'Patients without peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer', 'description': 'A panel of microRNA, whose expression level is tested exosomal microRNA from blood sample before second-line chemotherapy with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)', 'interventionNames': ['Drug: Paclitaxel']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Ramucirumab'], 'description': 'Gastric cancer second-line chemotherapy', 'armGroupLabels': ['Patients with peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer', 'Patients without peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7010192', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takeshi Nagasaka, PhD', 'role': 'CONTACT', 'email': 'nagasakatahino@gmail.com'}], 'facility': 'Kawasaki Medical University', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}], 'centralContacts': [{'name': 'Ajay Goel, PhD', 'role': 'CONTACT', 'email': 'AJGOEL@COH.ORG', 'phone': '6262183452'}, {'name': 'Koichi Takiguchi, PhD', 'role': 'CONTACT', 'email': 'ktakiguchi@coh.org', 'phone': '6262183452'}], 'overallOfficials': [{'name': 'Koichi Takiguchi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}