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A Phase 3, Multicenter Randomized Controlled Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Locally Advanced Squamous Cell Esophageal Carcinoma

A Phase 3, Multicenter Randomized Controlled Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery versus Surgery for Locally Advanced Squamous Cell Esophageal Carcinoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000133
Enrollment
Unknown
Registered
2008-07-27
Start date
2007-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Squamous Cell Esophageal Carcinoma

Interventions

Experimental Group:Neo-adjuvant Chemoradiotherapy followed by Surgery

Sponsors

Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: 1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable; 2. Patients must not have received any prior anticancer therapy; 3. More than 6 months of expected survival; 4. Age ranges from 18 to 60 years.5. Absolute white blood cells count >=4.0*10^9/L, neutrophil >=1.5*10^9/L, platelets >=100.0*10^9/L, hemoglobin >=90g/L, and normal functions of liver and kidney; 6. Karnofsky performance status more than 90; 7. Signed informed consent document on file.

Exclusion criteria

Exclusion criteria: 1. Patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine; 2. Patients with concomitant hemorrhagic disease; 3. Pregnant or breast feeding; 4. Inability to use gastric conduit after esophagectomy because of a prior surgery; 5. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more; 6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

Design outcomes

Secondary

MeasureTime frame
Disease free survival tim;

Primary

MeasureTime frame
Survival rate;Survival time;

Countries

China

Contacts

Public ContactJian-hua Fu, Meng-zhong Liu
fjh@medmail.com.cn+86 13902401851

Outcome results

None listed

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