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

NCT04138212 | Recruiting Phase 3

• 1 other identifier: 2019082223
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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

Keywords

esophageal squamous cell carcinoma; neoadjuvant chemotherapy; neoadjuvant chemoradiation therapy; randomized controlled; survival

Outcome Measures

Primary Outcomes (1)

• overall survival

  5 year

Secondary Outcomes (4)

• disease-free survival

  5 year

• pathological complete response

  3 months

• adverse events

  3 months

• postoperative complications

  3 months

Study Arms (2)

Chemotherapy group

ACTIVE COMPARATOR

Patients in this group will receive neoadjuvant chemotherapy.

Drug: Paclitaxel, Cisplatin

Chemoradiation group

EXPERIMENTAL

Patients in this group will receive neoadjuvant chemoradiation therapy.

Radiation: neoadjuvant chemoradiation therapy

Interventions

Paclitaxel, Cisplatin DRUG

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

Chemotherapy group

neoadjuvant chemoradiation therapy RADIATION

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

Chemoradiation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

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  PMID: 32293362 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

TP protocol; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Haibo Sun

CONTACT

+8615188301091; sunny-haipo@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending surgeon

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 24, 2019
• Study Start: October 22, 2019
• Primary Completion: December 21, 2023
• Study Completion (Estimated): December 21, 2028
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

CN (1)