Resectable advanced esophageal squamous cell carcinoma
Conditions
Interventions
Synbiotics intake in the perioperative management for resectable advanced esophageal cancer from preoperative chemotherapy to postoperative period
nutrition, tumor
Sponsors
Daiko Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Endoscopic biopsy of the primary esophageal lesion shows a histological diagnosis of squamous cell carcinoma. 2) Preoperative chemotherapy (DCF, FLOT) is planned. 3) All esophageal lesions (primary tumor, esophageal intramural metastasis, and intraepithelial extension) are confined to the thoracic esophagus (UICC-TNM, 8th edition). If the esophagectomy is resectable, the presence of a secondary lesion in the neck that is an absolute indication for EMR is also eligible. 4) Patients must have clinical stage cStage II, III, IVA, or IVB (excluding distant metastases) according to the TNM classification (UICC-TNM, 8th edition). 5) Patients is more than 18 years old and less than 80 years old on the date of enrollment. 6) Performance status (PS) is 0 to 2 according to the ECOG criteria (PS must be documented in the medical record). 7) No measurable lesions are required. 8) No prior treatment for esophageal cancer. However, the patient is eligible even if he/she has received any of the following treatments. 1 Curative resection by EMR/ESD with pT1a-LPM(M2) or less 2 Curative resection by EMR/ESD, pT1a-MM(M3), negative for vascular invasion 9) No prior chemotherapy, radiation therapy, or endocrine therapy, including other types of cancer. However, patients with a history of hormone therapy for prostate cancer are eligible if they have been disease-free for at least 5 years. 10) Latest laboratory values within 14 days prior to enrollment meet all of the following 11) Patient is judged to be eligible for radical esophageal cancer surgery (R0) by thoracoscopic surgery or mediastinoscopy (robot-assisted surgery) and laparoscopic surgery (or robot-assisted surgery). 12) Written consent to participate in the study has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of taking synbiotics 2) Patients with a history of hypersensitivity to the test product or to any component of DCF therapy 3) Patients who have difficulty ingesting the test product (e.g., oral intake is difficult, allergy to the test product (potato, corn, lactic acid bacteria and bifidobacteria beverages, dairy products) 4) Patients with a history of gastrectomy, intestinal resection, hepatectomy, or pancreatectomy 5) Patients with concurrent or iatrogenic overlapping/multiple cancers. However, the following cases are eligible. Patients with concurrent or heterochronic multiple cancers, but with early-stage cancers that are not expected to affect prognosis or operative procedures (regardless of carcinoma type). 6) Cases in which the patient is taking antimicrobial agents 7) Patients receiving the following drugs: steroids, warfarin potassium 8) Patients with serious comorbidities (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, diabetes mellitus difficult to control, uncontrolled hypertension, cardiac failure, renal failure, liver cirrhosis, liver failure, etc.) 9) Pregnancy or the possibility (intention) of pregnancy 10) Cases in which the principal investigator or subinvestigator determines that the subject is inappropriate for the research. 11) Cases requiring combined procedures such as pharyngolaryngoesophagectomy or total gastrectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of infectious complications including pneumonia, suture failure, and wound infection | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rates, Relative Dose Intensity (RDI), clinical and pathological treatment response, body weight, body composition, nutritional indices, overall survival, progression-free survival, fecal flora/organic acid concentration and pH measurements | — |
Contacts
Public ContactYuto Kubo
National Cancer Center Hospital East
Outcome results
None listed