NCT04138212 Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)
| NCT ID | NCT04138212 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Henan Cancer Hospital |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 456 participants |
| Start Date | 2019-10-22 |
| Primary Completion | 2023-12-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 456 participants in total. It began in 2019-10-22 with a primary completion date of 2023-12-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04138212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04138212 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 456 participants.
Is NCT04138212 currently recruiting?
Yes, NCT04138212 is actively recruiting participants. Contact the research team at sunny-haipo@hotmail.com for enrollment information.
Where is the NCT04138212 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT04138212 clinical trial?
NCT04138212 is sponsored by Henan Cancer Hospital. The trial plans to enroll 456 participants.