Menu
Recruiting NCT06490159

Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer

— Observational Gastric Cancer Chemotherapy-induced Peripheral Neuropathy Paclitaxel Ramucirumab

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Paclitaxel.
Who it may be relevant to
Registry conditions: Gastric Cancer, Chemotherapy-induced Peripheral Neuropathy, Paclitaxel, Ramucirumab. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Predicting Peripheral Neuropathy of Paclitaxel in Second-line Chemotherapy for Gastric Cancer

Overview

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.

Detailed description

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.

Interventions

  • Drug Paclitaxel
    Gastric cancer second-line chemotherapy

Primary outcome measures

  • Incidence of peripheral neuropathy [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • unresectable or recurrent Gastric cancer (GC) histologically confirmed to be primary adenocarcinoma of the stomach.
  • age over 20 years.
  • Eastern Cooperative Oncology Group performance status score of 0-2.
  • written informed consent following full study information is provided to the patient.
  • progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC.
  • presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging.

Exclusion criteria

  • Patients with a life expectancy of shorter than 3 months
  • Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency.
  • Patients with a history of serious allergic reactions or serious drug allergy.
  • Patients with a clinically relevant mental disorder that prohibits response to questionnaires.
  • Patients for whom the attending physician considered that enrollment in the study is inappropriate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Japan · 1 center
  • Kawasaki Medical University — Kurashiki

Publications

  • Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW PMID 25240821
  • 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 PMID 35130500
  • 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 28711577
  • 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 PMID 37068504
  • 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 35724467
  • 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 PMID 32532230
  • 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 21128110
  • 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 36322088

Identifiers

NCT: NCT06490159 · 23228/SLCGC-AE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗