Esophageal squamous cell carcinoma esophageal cancer, preoperative chemotherapy, FLOT therapy, squamous cell carcinoma
Conditions
Interventions
FLOT therapy, esophageal cancer, neoadjuvant chemotherapy
Sponsors
Miyata Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosed histologically with either squamous cell carcinoma, adenosquamous carcinoma, or basaloid squamous cell carcinoma through endoscopic biopsy of the primary esophageal lesion. The main site of the esophageal lesion (primary lesion, intramural metastasis, or intraepithelial extension) is located within the thoracic esophagus (according to UICC-TNM 8th edition). Classified as T1N1-3M0-1 or T2-3N0-3M0-1 (M1 is allowed only for supraclavicular lymph node metastasis) based on the TNM classification (UICC-TNM 8th edition). Age between 18 and 85 years at the time of registration. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1. The presence of measurable lesions at least No prior treatment for esophageal cancer, except in the following cases, which are still considered eligible: No prior history of chemotherapy, radiotherapy, or endocrine therapy for any type of cancer. However, patients with a history of hormonal therapy for prostate cancer may be eligible if they have been disease-free for more than five years. Laboratory values within 14 days before registration (same weekday two weeks prior to the registration date is acceptable) meeting the following criteria: Considered eligible for radical esophagectomy (R0) by robotic-assisted/thoracoscopic/open thoracic surgery and laparoscopic/robotic-assisted/open abdominal surgery. Patients who have provided written informed consent for participation in this clinical study.
Exclusion criteria
Exclusion criteria: Patients with active double cancers [including synchronous or multiple cancers, and metachronous or multiple cancers with a disease-free period of 3 years. However, lesions corresponding to carcinoma in situ (intraepithelial carcinoma) or mucosal cancer that are considered cured by local treatment are not included in active double/multiple cancers]. Patients with active systemic infections requiring treatment (defined as fever with bacterial infection confirmed by imaging or microbiological tests; localized infections that do not affect overall condition are excluded). Patients who are positive for HBs antigen or HIV antibodies (HIV antibody testing is not required for enrollment). Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. Men who wish for their partner to become pregnant. Patients with psychiatric disorders or psychiatric symptoms that are deemed to make participation in the study difficult. Patients receiving continuous systemic steroid administration (oral or intravenous). Patients requiring continuous use of flucytosine (Ancotil, Domelagin, Arcytosin, Cocor), phenytoin (Aleviatin, Hydantol, Phenytoin N), or warfarin potassium (Warfarin, Alepharin, Samofaron). Patients with a history of hypersensitivity to docetaxel (DTX), oxaliplatin (LOHP), or polysorbate 80-containing formulations. Patients with uncontrolled diabetes mellitus. Patients with severe emphysema or pulmonary fibrosis detected on pulmonary function tests or CT scans. Patients with uncontrolled hypertension. Patients with unstable angina (angina that has developed or worsened within the past 3 weeks) or a history of myocardial infarction within the past 3 months. Patients deemed inappropriate for participation in this study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological response rate Pathological complete response rate Treatment completion rate Radical resection rate Progression-free survival (PFS) Overall survival (OS) Incidence of adverse events related to neoadjuvant therapy Incidence of perioperative complications Incidence of late complications | — |
Contacts
Public ContactTakahito Sugase
Osaka International Cancer Institute
Outcome results
None listed