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Trial record 1 of 1 for:    NCT02459457
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A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT02459457
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : February 9, 2022
Sponsor:
Collaborators:
Huadong Hospital
Wuxi No. 4 People's Hospital
Jiangsu Cancer Institute & Hospital
The First Affiliated Hospital of Xiamen University
Jiangxi Provincial Cancer Hospital
Shanxi Province Cancer Hospital
Gansu Cancer Hospital
Information provided by (Responsible Party):
Kuai Le Zhao, MD, Fudan University

Study Description
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Brief Summary:
The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.

Condition or disease Intervention/treatment Phase
Stage III Esophageal Squamous Cell Carcinoma Drug: Paclitaxel and Cisplatin Drug: Paclitaxel and Fluorouracil Drug: Paclitaxel and Carboplatin Radiation: Radiotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Paclitaxel in Combination With Cisplatin(TP), Carboplatin(TC) or Fluorouracil(TF) Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Squamous Cell Carcinoma: A Three-Arm Randomized Phase III Trial
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Paclitaxel and Cisplatin (TP)
Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w*4
 Drug: Paclitaxel and Cisplatin
patients get Paclitaxel and Cisplatin according to protocol
Other Name: TP

Radiation: Radiotherapy
1.8Gy/d, d1-5/week, 34Fx
Active Comparator: Paclitaxel and Fluorouracil (TF)
Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w*2
 Drug: Paclitaxel and Fluorouracil
patients get Paclitaxel and Fluorouracil according to protocol
Other Name: TF

Radiation: Radiotherapy
1.8Gy/d, d1-5/week, 34Fx
Active Comparator: Paclitaxel and Carboplatin（TC）
Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w*2
 Drug: Paclitaxel and Carboplatin
patients get Paclitaxel and Carboplatin according to protocol
Other Name: TC

Radiation: Radiotherapy
1.8Gy/d, d1-5/week, 34Fx


Outcome Measures
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Primary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 1year, 2 years, 3 years ]
  2. adverse event [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

To be eligible for this study, patient must fulfill all of the following criteria:

  1. Histologically confirmed esophageal squamous cell carcinoma
  2. Clinical stages II, III or IVa based on the 6th UICC-TNM classification
  3. No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.
  4. Aged 18-75 years

  5. Adequate organ functions

    1. White blood cell (WBC) ≥3×109⁄L
    2. Absolute neutrophil counts (ANC) ≥1.5×109⁄L
    3. Hemoglobin (Hb) ≥10g⁄dl
    4. Platelet (Plt) ≥100×109⁄L
    5. Total bilirubin <1.5 upper limit of normal (ULN)
    6. Aspartate transaminase (AST) ≤2.5 ULN
    7. Alanine aminotransferase (ALT) ≤2.5 ULN
    8. Creatinine ≤1.5 ULN
  6. ECOG PS of 0-2
  7. Life expectancy ≥3 months
  8. Written informed consent

Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study.

  1. Esophageal perforation or hematemesis
  2. Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months)
  3. Received thoracic, abdominal or craniocerebral surgery within 30 days
  4. Enrolled in other clinical trials within 30 days
  5. Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
  6. Severe psychiatric disease
  7. Pregnancy, lactation or unwillingness to adopt contraception
  8. Drug addiction
  9. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
  10. Patients with hearing impairment or sensory-motor neuropathy of WHO grade > 1
  11. History of radiotherapy in the planning area
  12. Other ineligible conditions according to researchers
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459457


Locations
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China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Huadong Hospital
Wuxi No. 4 People's Hospital
Jiangsu Cancer Institute & Hospital
The First Affiliated Hospital of Xiamen University
Jiangxi Provincial Cancer Hospital
Shanxi Province Cancer Hospital
Gansu Cancer Hospital
Investigators
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Study Chair: Kuaile Zhao, MD +86 18017312534
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kuai Le Zhao, MD, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02459457    
Other Study ID Numbers: ESO-Shanghai 2
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: February 2022
Keywords provided by Kuai Le Zhao, MD, Fudan University:
esophageal squamous cell carcinoma
concurrent chemoradiotherapy
paclitaxel
 cisplatin
carboplatin
fluorouracil
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs