EPOC2 study -elementary diet for oral mucositis in patients with esophageal cancer receiving chemotherapy-

JRCT ID: jRCTs071180029

Registered date:05/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: esophageal cancer
• Date of first enrollment: 02/02/2017
• Target sample size: 160
• Study type: Interventional

Intervention(s)

Group A (DCF + elemental diet)
Docetaxel, cisplatin, 5-fluorouracil (2 courses)
Docetaxel(DOC) 35mg/m2 day1, day15
Cisplatin(CDDP) 40mg/m2 day1, day15
Fluorouracil (5-FU) 400mg/m2 day1-5, day15-19
(4 weeks)
Administration of elemental diet: 2 packets per day (9 weeks)
Group B (DCF)
Docetaxel, cisplatin, 5-fluorouracil (2 courses)
Docetaxel(DOC) 35mg/m2 day1, day15
Cisplatin(CDDP) 40mg/m2 day1, day15
Fluorouracil (5-FU) 400mg/m2 day1-5, day15-19
(4 weeks)

Outcome(s)

• Primary Outcome: Oral mucositis of more than Grade 2

Secondary Outcome

Body weight, CRP, Alb, Prealbumin,
lymphocytic change between two groups
incidence of oral mucositis on cases of neoadjuvant chemotherapy and inoperable/ recurrent cancer
adverse event except mucositis
Kaplan-Maier curve for inicial incidence of oral mucositis on every grade
grade of examination findings and function/ symptom of oral mucositis between two groups and its timing
compliance of elemental diet and DCF therapy
oral mucositis of more than grade 2 and completion rate of DCF therapy between two groups

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Yoshida Kazuhiro
• Secondary Sponsor: Kitagawa Yuko
• Source(s) of Monetary Support: EA Pharma Co., Ltd.
• Secondary ID(s): UMIN000025412