This study is to evaluate the effectiveness of treatment for esophagogastric junction carcinoma, total neoadjuvant therapy (TNT) including pembrolizumab and FLOT is conducted, aiming to choose between surgery or organ preservation treatment strategies.
In Immunochemotherapy before short-term radiation therapy, pembrolizumab 200mg will be intravenously infused at 21-day intervals for 2 doses. FLOT (docetaxel 50 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200mg/m2, 5-FU 2600 mg/m2) will be intravenously infused at 14-day intervals for 2 doses. Regarding short-term radiotherapy, irradiation will be delivered from day1 to day5, with a dose of 5 Gy per fraction for a total of 25 Gy. In Immunochemotherapy after short-term radiation therapy, pembrolizumab 200mg will be intravenously infused on day 8. FLOT will be intravenously infused on day 1 and day15. If CR or Near CR is achieved after the first and second efficacy assessment, pembrolizumab 200mg will be intravenously infused at 21-day intervals for 14 doses and FLOT will be intravenously infused at 14-day intervals for 4 doses as immunochemotherapy as non-operative management (NOM). If CR or Near CR is not achieved after the first or second efficacy assessment, surgery will be performed. And then pembrolizumab 200mg will be intravenously infused at 21-day intervals for 14 doses and FLOT will be intravenously infused at 14-day intervals for 4 doses as Postoperative adjuvant immunochemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Pembrolizumab 200mg will be administered via intravenous infusion over 30 minutes, twice at 21-day intervals.
Docetaxel 50 mg/m2 will be administered over 60 minutes.
Oxaliplatin 85 mg/m2 will be administered over 2 hours.
Leucovorin 200 mg/m2 will be administered over 2 hours.
5-FU 2600 mg/m2 will be administered over 24 hours.
25Gy (5Gy×5fr)
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
RECRUITING3-year event-free survival (EFS) rate
Time frame: 3 years
Organ-sparing survival
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Clinical response rate
Time frame: 3 years
Clinical complete response rate
Time frame: 3 years
Major pathological response rate (MPR rate)
Time frame: 3 years
Pathological complete response rate (pCR rate)
Time frame: 3 years
R0 resection rate (R0 rate)
Time frame: 3 years
TNT completion rate
Time frame: 3 years
Treatment completion rate
Time frame: 3 years
Adverse event incidence rate
Time frame: 3 years
Post-treatment ctDNA clearance
Time frame: 3 years
EORTC QLQ-C30
We are reporting scores from the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30). The scores were transformed to a 0-100 scale following the official EORTC scoring manual. For functional scales and global health status, higher scores indicate a better outcome. For symptom scales/items, higher scores indicate a worse outcome.
Time frame: 3 years
EORTC QLQ-OG25
We are reporting scores from the EORTC QLQ-OG25 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Oesophago-Gastric module). The scores were transformed to a 0-100 scale following the official EORTC scoring manual. All scales and single items in the QLQ-OG25 are symptom-based. Therefore, higher scores indicate worse symptoms or poorer quality of life.
Time frame: 3 years
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