Comparing chemotherapy and chemoradiotherapy before surgery for esophageal cancer
Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)
This study is testing whether giving patients with esophageal cancer chemotherapy or a combination of chemotherapy and radiation before surgery helps them live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 456 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT04138212 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy in improving overall survival for patients with resectable locally advanced esophageal squamous cell carcinoma. A total of 456 patients will be randomly assigned to receive either chemotherapy with paclitaxel and cisplatin or chemoradiotherapy with paclitaxel and carboplatin combined with radiation before undergoing surgery. The study seeks to determine which treatment approach offers better survival outcomes over a five-year period.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with locally advanced esophageal squamous cell carcinoma who meet specific staging criteria and have no prior cancer treatment.
Not a fit: Patients with metastatic disease, previous cancer treatment history, or those who cannot undergo surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment protocol for patients with locally advanced esophageal cancer, potentially improving survival rates.
How similar studies have performed: Previous studies have shown varying success with neoadjuvant therapies in esophageal cancer, but this specific comparison of chemotherapy versus chemoradiotherapy is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zhengzhou, Henan
- Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Haibo Sun
- Email: sunny-haipo@hotmail.com
- Phone: +8615188301091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.