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

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ClinicalTrials.gov Identifier: NCT04138212
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Haibo Sun, Henan Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Paclitaxel, Cisplatin Radiation: neoadjuvant chemoradiation therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : October 21, 2022
Estimated Study Completion Date : October 21, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Chemotherapy group
Patients in this group will receive neoadjuvant chemotherapy.
Drug: Paclitaxel, Cisplatin
Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles

Experimental: Chemoradiation group
Patients in this group will receive neoadjuvant chemoradiation therapy.
Radiation: neoadjuvant chemoradiation therapy
Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d*23




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 year ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138212


Contacts
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Contact: Haibo Sun +8615188301091 sunny-haipo@hotmail.com

Locations
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China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
Contact: Haibo Sun    +8615188301091    sunny-haipo@hotmail.com   
Principal Investigator: Haibo Sun         
Sponsors and Collaborators
Henan Cancer Hospital
Publications:

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Responsible Party: Haibo Sun, Attending surgeon, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT04138212    
Other Study ID Numbers: 2019082223
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haibo Sun, Henan Cancer Hospital:
esophageal squamous cell carcinoma
neoadjuvant chemotherapy
neoadjuvant chemoradiation therapy
randomized controlled
survival
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal 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
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action