Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiation Therapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)
Summary
Multimodal treatment combining surgery with chemotherapy and/or radiotherapy is necessary to improve the chances of survival in patients with locally advanced thoracic esophageal cancer. However, there is no consensus about the neoadjuvant treatment for resectable locally advanced esophageal squmous cell carcinoma. The aim of current randomized controlled clinical trail is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiation therapy plus surgery on overall survival for patients with resectable locally advanced esophageal squmous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal quamous cell carcinoma in 3 years. Eligible patients will be randomized into neoadjuvant chemotherapy group (paclitaxel 175mg/m2 plus cisplatin 75mg/m2, q21d, 2 cycles) or neoadjuvant chemoradiation group (41.4Gy, 1.8Gy*23d plus paclitaxel 50mg/m2 plus carboplatin AUC=2, q1w, 5 cycles). The primary endpoint is 5 year overall survival and the secondary endpoints include 5 year disease-free survival, adverse events, patholical complete response, postoperative complications, quality of life. The biomarkeres predicting the sensitivity of neoadjuvant therapy will be explored.
Study Design
Conditions
Esophageal Squamous Cell Carcinoma
Intervention
Paclitaxel, Cisplatin, neoadjuvant chemoradiation therapy
Location
Henan Cancer Hospital
Zhengzhou
Henan
China
450008
Status
Recruiting
Source
Henan Cancer Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04138212
- ClinicalTrials.gov processed this data on October 29, 2019
Published on BioPortfolio: 2019-10-29T14:36:42-0400
Clinical Trials
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This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel+cisplatinï¼...
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Medical and Biotech [MESH] Definitions
Neoadjuvant Therapy
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
Cisplatin
An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.
Neoplasms, Squamous Cell
Neoplasms composed of squamous cells of the epithelium. The concept does not refer to neoplasms located in tissue composed of squamous elements.
Albumin-bound Paclitaxel
An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.
Atypical Squamous Cells Of The Cervix
Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.
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