Study on elemental diet for oral mucositis of DCF in patients with esophageal cancer -Randomized Phase III study: EPOC2 study- - Study on elemental diet for oral mucositis of DCF in patients with esophageal cancer -Randomized Phase III study: EPOC2 study

Yoshida Kazuhiro0 个研究点目标入组 113 人开始时间: 2019年3月5日最近更新: 2023年10月17日

适应症

试验速览

We showed that ED has a preventive effect on OM in patients with EC receiving DCF regimen.

•1) Histologically revealed squamous cell carcinoma and adenosquamous cell carcinoma and adenocarcinoma.*
•Synchronous multiple esophageal carcinoma cases that can be treated at one time and metachronous multiple carcinoma cases can be registered. Even in the presence of simultaneous or metachronous duplicated cancers, registration can be posible if this chemotherapy regimen (Biweekly-DCF) is clinically given with priority for the treatment of esophageal cancer.
•*In case of esophageal adenocarcinoma, Siewert type I is only allowed.
•2) The following cases where DCF therapy can be started within 3 weeks after registration. (UICC TNM Classification 7th Edition)
•i) Neoadjyuvant chemotherapy cases for Stage II,III.
•ii) Inoperable, recurrent cases
•3) 20<= years old <=75
•4) PS(ECOG)0 or 1
•5) BSA(DuBois)<=2.2m2
•6) 4,000 /mm3<= WBC<=12,000/mm3
•Neutro>=2,000 /mm3
•Plt>=100,000 /mm3
•Hb>=8.0 g/dL
•AST<=100 IU/L
•ALT<=100 IU/L
•T.Bil<=1.2 mg/dL
•Cre<=1.2 mg/dL
•ccr>=60 mL/min
•7) Dysphagia score<=2
•8) required to sign an informed consent form approved by the Ethical Committee

•1) Diabetes mellitus using insulin.
•3) Women who are pregnant or breast feeding
•4) A woman who is likely to become pregnant, a man with productive ability.
•5) Cases in which the endpoint participates in another clinical trial with overlapping.
•6) Cases with a history of hypersensitivity to DOC, CDDP, 5-FU, and polysorbate 80 containing formulations.
•7) Cases in which administration of Elental is contraindicated.
•8) Cases under active infection
•9) Steroidal users.
•10) Neurological deficit. >=G1
•11) Edema >=G2
•12) Intestinal pneumonia
•13) Cases in which psychosis or psychiatric symptoms are merged and it is deemed difficult to participate in the study.
•14) Judged by physicians as inappropriate for this study.
•15) Cases with chronic hepatitis / liver cirrhosis status.
•16) Cases with symptomatic bone metastasis / brain metastasis at registration.
•17) Cases with massive pleural effusion (occupying more than 1/2 of either of the right or left chest cavity) or massive ascites (continuing from the pelvic area to the upper abdomen) at registration.
•18) At the time of enrollment (CTCAE v3.0), cases of oral mucositis of Grade 1 or higher.
•19) Cases of severe damping symptoms

发起方

Yoshida Kazuhiro