Clinical trial NCT04138212: Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)
Official title: Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
neoadjuvant chemotherapy
neoadjuvant chemoradiation therapy
randomized controlled
survival
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2019-10-24
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 squamous 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 squamous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal squamous 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, pathologic complete response, postoperative complications, quality of life. The biomarkers predicting the sensitivity of neoadjuvant therapy will be explored.


Eligibility criteria: Inclusion Criteria:

* cT2-T4aN+M0 or cT3-4aN0M0 (8th TNM staging system) thoracic esophageal squamous cell carcinoma
* No metastatic cervical lymph node
* No anti-cancer treatment
* No contraindication for esophagectomy
* No contraindication for chemotherapy or chemoradiation therapy
* PS score 0-1
* Written consent is obtained

Exclusion Criteria:

* Previous cancer treatment history
* Concurrent cancer disease in other site
* Tumor length ≥8cm
* Tumor width ≥5cm
* Need continuous steroid treatment
* Cardiac infarction in 6 months
* Psychotic patient
* Can not achieve R0 resection
* Gastric tube can not be used for reconstruction after esophagectomy
* Pregnant woman

Primary outcomes:
measure: overall survival
timeFrame: 5 year
Secondary outcomes:
measure: disease-free survival
timeFrame: 5 year
measure: pathological complete response
timeFrame: 3 months
measure: adverse events
timeFrame: 3 months
measure: postoperative complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
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