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Randomized prospective clinical trial of paclitaxol/carboplatin induction chemotherapy combine with surgery for local advanced esophageal cancer

Randomized prospective clinical trial of paclitaxol/carboplatin induction chemotherapy combine with surgery for local advanced esophageal cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002037
Enrollment
Unknown
Registered
2012-02-27
Start date
2011-05-01
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

esophageal cancer

Interventions

group A:surgery with induction chemotherapy
group B:surgery with adjuvant chemotherapy
group C:surgery

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. esophageal sqamous cell cancer with pathologic diagnosis, without any prior treatment; 2. local advanced stage, cT3N2M0(IIIb), cT4aN1-2M0(IIIc), cT4bNanyM0(IIIc), cTanyN3M0(IIIc); 3. 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; 4. Karnofsky performance status more than 90; 5. More than 6 months of expected survival; 6. Age ranges from 18 to 75 years; 7. Signed informed consent document on file.

Exclusion criteria

Exclusion criteria: 1. Patients with prior treatment for esophageal cancer; 2. Without prior large surgery within 6 months; 3. With a prior malignancy tumor, excluding DFS > 3 years; 4. Can not sign informed consent document on file for psychological, familial and societal factors; 5. Patients are diagnosed to be allergic to paclitaxol or carboplatin.

Design outcomes

Primary

MeasureTime frame
size of tumor;size of lymph node;pathologic result of tumor;pathologic result of lymph node;gastrointestinal side reaction;myelosuppressive side reaction;local recurrence;longterm survival;

Contacts

Public ContactFang Wentao
vwtfang@hotmail.com+86 13901867516

Outcome results

None listed

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