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Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial

Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058486
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-04-11
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Esophageal Squamous Cell Carcinoma

Interventions

Group B:Definitive chemoradiotherapy

Sponsors

Cancer Hospital Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with cervical esophageal squamous cell carcinoma of cT1b-4aN0-3 clinical stage before treatment (8thUICC-TNM stage). Patients with squamous cell carcinoma of the hypopharynx and squamous cell carcinoma of the upper thoracic esophagus can join this study; patients with T4b cervical esophageal cancer with cervical tracheal involvement but complete resection can join this study; 2. Patients aged 18-75 years; 3. There are no surgical contraindications in the preoperative evaluation of various organ functions; 4. The following laboratory tests have confirmed that the bone marrow, liver and kidney functions meet the requirements for participating in the study: hemoglobin >= 90 g/L; white blood cell count >= 4.0 x 10^9 /L; absolute value of granulocytes (ANC) >= 1.5 x 10^9 /L; platelet count >= 100 x 10^9 /L; total bilirubin <= 1.5 times upper limit of normal value; ALT and AST <= 2.5 times upper limit of normal value; international normalized ratio of prothrombin time <= 1.5 times upper limit of normal value, and partial thromboplastin time Within the normal range; creatinine <= 1.5 times the upper limit of normal; 5. No other history of malignant tumors, excluding patients with prostate cancer who received hormone therapy and obtained DFS for more than 5 years; 6. R0 resection is expected to be achieved; 7. Physical status ECOG: 0-2; 8. The subjects must understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with a history of other malignant tumors (except those combined with squamous cell carcinoma of the hypopharynx and squamous cell carcinoma of the upper thoracic esophagus); 2. Mentally ill patients; 3. Those who already have or have bleeding disorders; 4. Other uncontrollable inoperable patients; 5. Female patients who are pregnant or breastfeeding; 6. Allergy to chemotherapy drugs paclitaxel and cisplatin.

Design outcomes

Primary

MeasureTime frame
5 year overall survival;

Secondary

MeasureTime frame
Laryngo-esophageal dysfunction free survival, LDFS;

Countries

China

Contacts

Public ContactJie He

Cancer Hospital Chinese Academy of Medical Sciences

liyin@cicams.ac.cn+86 10 87788052

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026