Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)

NCT ID: NCT04138212

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-22
• Study Completion Date: 2028-12-21

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy group

Patients in this group will receive neoadjuvant chemotherapy.

Group Type: ACTIVE_COMPARATOR

Paclitaxel, Cisplatin

Intervention Type: DRUG

Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles

Chemoradiation group

Patients in this group will receive neoadjuvant chemoradiation therapy.

Group Type: EXPERIMENTAL

neoadjuvant chemoradiation therapy

Intervention Type: RADIATION

Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d\*23

Interventions

Paclitaxel, Cisplatin

Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles

Intervention Type: DRUG

neoadjuvant chemoradiation therapy

Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d\*23

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Haibo Sun

Attending surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haibo Sun

Role: CONTACT

sunny-haipo@hotmail.com

+8615188301091

Facility Contacts

Haibo Sun

Role: primary

sunny-haipo@hotmail.com

+8615188301091

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Other Identifiers

2019082223

Identifier Type: -

Identifier Source: org_study_id