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Trial record 22 of 386 for:    Recruiting, Not yet recruiting, Available Studies | "Esophageal Neoplasms"

Adjuvant Therapies or Surgery Alone for High Risk pN0 Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT02891083
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Collaborators:
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:

No.


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 ]


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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:

  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 ClinicalTrials.gov identifier (NCT number): NCT02891083


Contacts
Contact: Wentao Fang, MD +86-21-62821990 ext 2901 vwtfang12@shcheat.org
Contact: Xufeng Guo, MD +86-21-62821990 ext 2608 shandagxf@126.com

Locations
China
Shanghai Chest Hospital Recruiting
Shanghai, China, 200030
Contact: Wentao Fang, MD    +86-21-62821990 ext 2901    vwtfang12@shchest.org   
Contact: Xufeng Guo, MD    +86-21-62821900 ext 2608    shandagxf@126.com   
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
Investigators
Principal Investigator: Wentao Fang, MD Shanghai Chest Hospital

Publications of Results:
Responsible Party: Wentao Fang, Chief Director,Clinical Center of Esophageal Diseases,Shanghai Jiao tong University, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT02891083     History of Changes
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
surgery
squamous cell carcinoma

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action