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Neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for locally advanced oesophageal squamous cell carcinoma: a single-Centre, open-label, randomized, controlled, clinical trial (HCHTOG1903).
- Source :
- BMC Cancer; 4/15/2020, Vol. 20 Issue 1, p1-8, 8p, 2 Diagrams
- Publication Year :
- 2020
-
Abstract
- <bold>Background: </bold>Neoadjuvant therapy plus oesophagectomy has been accepted as the standard treatment for patients with potentially curable locally advanced oesophageal cancer. No completed randomized controlled trial (RCT) has directly compared neoadjuvant chemotherapy and neoadjuvant chemoradiation in patients with oesophageal squamous cell carcinoma (ESCC). The aim of the current RCT is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiotherapy plus surgery on overall survival for patients with resectable locally advanced ESCC.<bold>Methods: </bold>This open label, single-centre, phase III RCT randomized patients (cT2-T4aN + M0 and cT3-4aN0M0) in a 1:1 fashion to receive either the CROSS regimen (paclitaxel 50 mg/m2; carboplatin (area under the curve = 2), q1w, 5 cycles; and concurrent radiotherapy, 41.4 Gy/23 F, over 5 weeks) or neoadjuvant chemotherapy (paclitaxel 175 mg/m2; and cisplatin 75 mg/m2, q21d, 2 cycles). Assuming a 12% 5-year overall survival difference in favour of the CROSS regimen, 80% power with a two-sided alpha level of 0.05 and a 5% dropout each year for an estimated 3 years enrolment, the power calculation requires 456 patients to be recruited (228 in each group). The primary endpoint is 5-year overall survival, with a minimum 5-year follow-up. The secondary endpoints include 5-year disease-free survival, toxicity, pathological complete response rate, postoperative complications, postoperative mortality and quality of life. A biobank of pre-treatment and resected tumour tissue will be built for translational research in the future.<bold>Discussion: </bold>This RCT directly compares a neoadjuvant chemotherapy regimen with a standard CROSS regimen in terms of overall survival for patients with locally advanced ESCC. The results of this RCT will provide an answer for the controversy regarding the survival benefits between the two treatment strategies.<bold>Trial Registration: </bold>NCT04138212, date of registration: October 24, 2019. [ABSTRACT FROM AUTHOR]
- Subjects :
- CHEMORADIOTHERAPY
SQUAMOUS cell carcinoma
CANCER chemotherapy
CLINICAL trials
RANDOMIZED controlled trials
PROGRESSION-free survival
THERAPEUTIC use of antineoplastic agents
EXPERIMENTAL design
RESEARCH
FERRANS & Powers Quality of Life Index
CARBOPLATIN
RESEARCH methodology
ANTINEOPLASTIC agents
EVALUATION research
MEDICAL cooperation
TREATMENT effectiveness
TUMOR classification
COMPARATIVE studies
DIGESTIVE organ surgery
CISPLATIN
SURVIVAL analysis (Biometry)
IMPACT of Event Scale
RESEARCH funding
PACLITAXEL
COMBINED modality therapy
ESOPHAGEAL tumors
Subjects
Details
- Language :
- English
- ISSN :
- 14712407
- Volume :
- 20
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- BMC Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 142737651
- Full Text :
- https://doi.org/10.1186/s12885-020-06824-2