Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: chemoradiation with weekly 5Fu and oxaliplatin, Perioperative mFLOT, Perioperative FOLFOX.
- Who it may be relevant to
- Registry conditions: Esophagogastric Junction Disorder, Neoplasms. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomised Controlled Trial Comparing Perioperative FLOT, FOLFOX and Preoperative Chemoradiation for Locally Advanced Esophagogastric Junction Adenocarcinoma
Overview
Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.
Interventions
- Radiation chemoradiation with weekly 5Fu and oxaliplatin
5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week - Drug Perioperative mFLOT
Perioperative docetaxel 50mg/m2；oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles - Drug Perioperative FOLFOX
Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles
Primary outcome measures
- 3 year of disease free survival [Time frame: 3 year]
Secondary outcome measures (3)
- 5 year of overall survival [Time frame: 5 year]
- Rate of pathological complete remission [Time frame: 1 year]
- Anastomosis leak rate [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- informed consensus of the enrolled patients
- from 18 to 75 years old
- proven to be primary adenocarcinoma of EGJ
- pre-operative staging cT3-4N+M0
- no prior other chemotherapy and/or radiation against the disease
- normal function of all other vital organs including heart,liver ,kidney and so on
- Eastern Cooperative Oncology Group performance status: 0\~2
Exclusion criteria
- history of other malignancy
- allergic reaction to capecitabine or oxaliplatin
- enrolled in other clinical trials
- abnormal GI tract function
- dysfunction of other organs
- pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy
- other situations judged as not adaptive to the study by investigators
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT03961841 · SAHMO202