Comparing surgery and chemoradiotherapy for cervical esophageal cancer
Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial
This study is testing whether surgery or a combination of chemotherapy and radiation works better for people with cervical esophageal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05327517 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of surgery versus definitive chemoradiotherapy in patients diagnosed with resectable cervical esophageal squamous cell carcinoma. Eligible participants will be those aged 18-75 who meet specific health criteria and have signed informed consent. The primary intervention involves esophagectomy, and the study will assess overall survival rates between the two treatment approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18-75 with resectable cervical esophageal squamous cell carcinoma who meet the specified health criteria.
Not a fit: Patients with inoperable cervical esophageal cancer or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment option for patients with cervical esophageal cancer, potentially improving survival rates.
How similar studies have performed: Other studies have explored similar treatment comparisons in esophageal cancer, showing varying degrees of success, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with resectable cervical esophageal squamous cell carcinoma (cT1b-T4aN0-3M0); * Cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included; * Aged 18-75 years; * Without any contraindication of operation; * Hemoglobin \>=90 g/L; Leukocytes \>=4.0x10\^9/L; Absolute neutrophil count \>=1.5x10\^9/L; Platelet \>=100x10\^9/L;Total bilirubin \<=1.5 ULN; ALT \<=2.5 ULN; AST \<=2.5 ULN; Serum creatinine \<=1.5 ULN or creatinine clearance rate \>=50 mL/min (Cocheroft-Gault);INR \<=1.5 ULN; APTT \<=1.5 ULN; * Without other malignancies; * Expected R0 resection; * ECOG PS 0-1; * Volunteered to participate in the study, signed the informed consent form. Exclusion Criteria: * Without other malignancies; * With mental diseases; * With hemorrhagic disease; * Inoperable patients; * Pregnant or lactating women; * Has a history of allergy to paclitaxel or cisplatin
Where this trial is running
Beijing
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yin Li, MD — Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
- Study coordinator: Zhen Wang, MD
- Email: wangzhen@cicams.ac.cn
- Phone: +8613600892432
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.