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NCT Number: NCT02395705

Neoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma

The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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About this study

The effect of Neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of Neo-adjuvant therapy for esophageal carcinomas. Therefore, the optimal management of resectable esophageal squamous cell carcinomas differs widely among different areas based on local randomized controlled trials.

The neo-adjuvant chemotherapy might be a good strategy if sufficient local control is achieved by surgical treatment. This study defined the detail of surgery procedure and the region of lymphadenectomy and adopted cisplatin and paclitaxel as neoadjuvant chemotherapy regimens. We try to evaluate the efficacy and safety of this neo-adjuvant strategy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIA to IIIB, (7th Union for International Cancer Control, UICC-TNM).
  • Patients must not have received any prior anticancer therapy of esophageal carcinoma.
  • Age ranges from 18 to 75 years.
  • Without operative contraindication.
  • Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney, total bilirubin(TBIL)≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.
  • Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS).
  • expected R0 resection.
  • ECOG 0~2.
  • Signed informed consent document on file. 10.No metastatic lymph node in cervical by color doppler sonography.

Exclusion criteria

  • Multiple primary cancer.
  • The subject cannot understand and sign the informed consent form(ICF).
  • Patients with concomitant hemorrhagic disease.
  • Any un expected reason for patients can't get operation.
  • Inability to use gastric conduit after esophagectomy because of a prior surgery.
  • Pregnant or breast feeding.
  • Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.

Treatment and study plan

cisplatin and paclitaxel

Drug
  • Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
  • Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
  • Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.

Other names: TP

Primary outcomes

  1. Overall survival rate

    Time frame: 5 years

Secondary outcomes

  1. Overall survival rate

    Time frame: 1 years and 3 years

  2. Disease free survival

    Time frame: 5 years

  3. assessment in perioperation-Removal rate (R0 resection rate)

    Time frame: perioperative period

    The R0 resection rate of two groups

  4. assessment in perioperation-Rate of Operative Complication

    Time frame: perioperative period

    Complication rate after operation before discharge

  5. assessment in perioperation-Mortality of perioperation

    Time frame: perioperative period

    Mortality of perioperation 20 days before operation and 30 days after operation

  6. assessment in perioperation-Days of Hospitalization

    Time frame: perioperative period

    Days of Hospitalization after operation

  7. assessment in perioperation-Thoracic Drainage

    Time frame: perioperative period

    Thoracic Drainage days

  8. assessment in perioperation-Quantity of bleeding

    Time frame: perioperative period

    blood lose during operation

  9. assessment in perioperation-Time of operation

    Time frame: perioperative period

    the time from open thoracic cavity to the closure of the thoracic cavity

  10. Quality of life

    Time frame: 1 years

    ECOG, KPS, NRS-2002, EORTC QLQ-ST018, EORTC QLQ-C30

  11. efficacy of neo-adjuvant chemotherapy--response rate

    Time frame: 1-4 days before operation

    Criteria:Response Evaluation Criteria in Solid Tumors,RECIST. Pathologic Complete Response Rate. Pathologic Response Rate.

  12. toxicities of neo-adjuvant chemotherapy

    Time frame: from chemotherapy to perioperative period

    According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0). The complete rate of protocol

  13. prognostic factors

    Time frame: 5 years

    prognostic factors for overall survival of both groups

  14. predictive factors

    Time frame: 2 years

    predictive factors for the efficiency of neo-adjuvant chemotherapy

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Hunan Province Tumor Hospital
  • Peking University Cancer Hospital & Institute
  • Sun Yat-sen University
  • Tianjin Medical University Cancer Institute and Hospital

Registry information

Official study title

A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemotherapy Paclitaxel + Cisplatin Versus Surgery Alone for Stage IIA-IIIB Esophageal Squamous Cell Carcinoma

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2015
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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