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Adjuvant Therapies or Surgery Alone for High Risk pN0 Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02891083
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Tianjin Medical University Cancer Institute and Hospital
Sun Yat-sen University
Sichuan Cancer Hospital and Research Institute
Hunan Cancer Hospital
Fujian Cancer Hospital
Fudan University
Qingdao University
Fujian Medical University
Wuhan TongJi Hospital
Information provided by (Responsible Party):
Wentao Fang, Shanghai Chest Hospital

Brief Summary:
Histological Node Negative thoracic esophageal squamous cell carcinoma(pN0 ESCC) after radical resection still carries the risk of recurrence after complete surgical resection, especially in some high-risk patients. There are still lack of knowledge on postoperative treatment indication and methods for pN0 ESCC.Our previous study has shown that risk of recurrence is associated with the location and cell differentiation of primary tumor, as well as the presence of lymphovascular invasion. This project is designed to study the efficacy of adjuvant therapies for at patients with pN0 ESCC and above mentioned risk factors of recurrence after radical surgery. We aim to compare the differences among adjuvant chemotherapy, adjuvant radiotherapy, and surgery alone for pN0 ESCC by prospective randomized controlled trial. There has been no similar studies in esophageal cancer previously reported with similar design. The results of this study is expected to have a high clinical relevance.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Drug: Adjuvant chemotherapy (Paclitaxel and Cisplatin) Radiation: Adjuvant radiotherapy Other: Control group (Surgery alone) Phase 3

Detailed Description:

The study is designed to be a prospective randomized controlled trial, aiming to compare the impact of adjuvant chemotherapy with Paclitaxel and Cisplatin, adjuvant radiotherapy with IMRT of 50Gy, and surgery alone on the disease free survival (DFS) of patients with high-risk pN0 thoracic esophageal squamous cell carcinoma. Pathological staging is to be based on the 7th UICC edition, after radical resection and systemic lymph node dissection,for accurate staging.Patients with pT1b-T4a disease, proved to be pN0 upon pathological examination, meet at least one of the risk factors in the inclusion criteria, and without any exclusion criteria are to be randomized into one of the three study arms.Definition of high-risk factors for recurrence include: (1)Tumor location: in the middle or upper third thoracic esophagus; (2) Presence of LVI or submucosal metastasis; (3) Cell differentiation: poorly differentiated or undifferentiated.

Primary endpoint:

To observe and compare Disease-Free Survivals (DFS) among the three study arms.

Secondary endpoint:

To observe and compare Overall Survivals (OS) among the three study arms, and to compare adverse events between adjuvant chemotherapy and adjuvant radiation groups.

Additional instructions:


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Prospective Randomized Controlled Clinical Trial of Postoperative Adjuvant Chemotherapy, Adjuvant Radiotherapy, or Surgery Alone for High-risk Histological Node Negative Patients With Thoracic Esophageal Squamous Cell Carcinoma
Study Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Adjuvant chemotherapy group
Surgery followed by adjuvant chemotherapy,with Paclitaxel and Cisplatin.
Drug: Adjuvant chemotherapy (Paclitaxel and Cisplatin)
Adjuvant chemotherapy group: three cycles: (Paclitaxel: 175mg/m2 ivgtt, 3h, d1 4week × 3 and cisplatin: 75mg/m2 ivgtt, d1 4 week × 3)
Other Name: Paclitaxel and Cisplatin

Experimental: Adjuvant radiotherapy group
Surgery followed by 50Gy adjuvant radiotherapy
Radiation: Adjuvant radiotherapy

Target: the upper mediastinum and bilateral supraclavicular region (Upper bound: thyrocricoid, lower bound: carina of 3cm)

Dose: 50Gy

Technology: strong tone

Segmentation: conventional segmentation 2Gy/d

Other Name: cobalt-60

Control group
Surgery alone
Other: Control group (Surgery alone)
Other Name: Surgery alone

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

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
  2. side effect of adjuvant therapy [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Inclusion Criteria:

  1. Patient: No pretreatment before surgery.Informed consent signed after screening;
  2. Surgery: Complete (R0) resection of tumor, with thoraco- abdominal two-field or cervico-thoraco-abdominal three-field lymph node dissection through transthoracic esophagectomy. At least 12 stations and 12 lymph nodes should be harvested, including bilateral recurrent laryngeal nerve nodes. Both open thoracotomy and minimally invasive thoracoscopic/laparoscopic approaches are allowed and histopathological examination confirmed the diagnosis of the patients with at least cleaning more or equal to 12 stations and 12 lymph nodes;
  3. Histology: Thoracic esophageal squamous cell carcinoma, with no nodal involvement (pN0) after pathological examination;
  4. Staging: Tumor T stage T1b-T4a according to the 7th UICC esophageal cancer staging system;
  5. Definition of high risk for recurrence: meet at least one of the three below.

    A: Primary tumor located in middle or upper third of thoracic esophagus

    B: Presence of lymphovascular invasion (LVI) or submucosal metastasis

    C: Cell differentiation:Low grade or undifferentiated

  6. Performance status: ECOG score 0-2;
  7. Cardiac function:NYHA classification 1-2. Normal electrocardiogram;
  8. Renal function: Normal serum creatinine level (SCr = 120mol/L) and creatinine clearance rate (CCr = 60 ml/min);
  9. Hepatic function: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level less than or equal to 2.0 times the upper limit of normal (ULN). Serum alkaline phosphatase (ALP) level less than or equal to four times the upper limit of normal value. Serum total bilirubin level less than or equal to 1.5 times the upper limit of the normal value;
  10. Hematopoietic function: White blood cell count (WBC) equal to or more than 4000 / μL,neutrophils (ANC) absolute count is more than or equal to 1500 / μ L, platelet count more than or equal to 100000/ μ L, hemoglobin equal to or more than 10.0 g / dl.

Exclusion Criteria:

  1. Surgery through Left thoracic or transhiatal approach, whereby complete lymphadenectomy is not achieved;
  2. Patients experienced severe postoperative complication and thus, are unable to tolerate any adjuvant therapy;
  3. Patients who have concommitant other malignant tumor;
  4. Patients with abnormal coagulation function, with bleeding tendencies (such as active peptic ulcer) or are currently receiving thrombolysis or anticoagulation therapies;
  5. Severe cardiac comorbidities, including congestive heart failure,uncontrolled cardiac arrhythmia, unstable angina pectoris, myocardial infarction within six months,severe heart valve disease, or intractable hypertension;
  6. Severe hepatic or renal insufficiency;
  7. Poor mental status or mental disorders, poor compliance.

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 identifier (NCT number): NCT02891083

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Contact: Wentao Fang, MD +86-21-62821990 ext 2901
Contact: Xufeng Guo, MD +86-21-62821990 ext 2608

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Shanghai Chest Hospital Recruiting
Shanghai, China, 200030
Contact: Wentao Fang, MD    +86-21-62821990 ext 2901   
Contact: Xufeng Guo, MD    +86-21-62821900 ext 2608   
Sponsors and Collaborators
Shanghai Chest Hospital
Tianjin Medical University Cancer Institute and Hospital
Sun Yat-sen University
Sichuan Cancer Hospital and Research Institute
Hunan Cancer Hospital
Fujian Cancer Hospital
Fudan University
Qingdao University
Fujian Medical University
Wuhan TongJi Hospital
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Principal Investigator: Wentao Fang, MD Shanghai Chest Hospital
Publications of Results:
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Responsible Party: Wentao Fang, Chief Director,Clinical Center of Esophageal Diseases,Shanghai Jiao tong University, Shanghai Chest Hospital Identifier: NCT02891083    
Other Study ID Numbers: 2016shchest
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wentao Fang, Shanghai Chest Hospital:
adjuvant chemotherapy
adjuvant radiotherapy
lymph node metastasis
squamous cell carcinoma
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action