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NCT Number: NCT04138212

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location status: Recruiting

Location contact

Haibo Sun

CONTACT

[email protected]

+8615188301091

Haibo Sun

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paclitaxel, Cisplatin

Drug

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

neoadjuvant chemoradiation therapy

Radiation

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

Primary outcomes

  1. overall survival

    Time frame: 5 year

Secondary outcomes

  1. disease-free survival

    Time frame: 5 year

  2. pathological complete response

    Time frame: 3 months

  3. adverse events

    Time frame: 3 months

  4. postoperative complications

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Haibo Sun

CONTACT

[email protected]

+8615188301091

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)

Acronym: HCHTOG1903

Important dates

Study start
2019
Primary completion
2023
Study completion
2028
First posted
Oct 24, 2019
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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