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Phase II Study of Neo-adjuvant Chemoradiotherapy for Squamous Cell Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT02938195
Recruitment Status : Unknown
Verified October 2016 by Jun Liu, Shanghai Chest Hospital.
Recruitment status was:  Recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Jun Liu, Shanghai Chest Hospital

Brief Summary:
The investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Chemoradiation Surgery Radiation: radiotherapy Procedure: Surgery Phase 2

Detailed Description:

Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 480,000 new cases and 400,000 deaths occurred annually worldwide. In China, either new cases or deaths account for more than half of the world. Morever, over 90% of Chinese patients have esophageal squamous cell carcinoma (ESCC).

Surgery is the main treatment of this disease, but the prognosis of patients with locally advanced esophageal cancer is rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.

Neo-adjuvant chemoradiotherapy followed by surgery seems hopeful to improve the survival of EC. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. However,a recent meta-analysis has indicated that an increased risk of postoperative mortality and treatment-related mortality was apparent in ESCC with the treatment of neo-adjuvant chemoradiotherapy.

Compare to surgery alone,the advantage of neoadjuvant chemoradiotherapy is reflected in the significantly higher percentage of R0 resections and higher rate of pathological complete response.

Thus,the investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.

Radiotherapy:Patients will be conducted CT simulation, and three-dimensional radiation therapy or Intensity-modulated radiation therapy was performed. 1.8Gy/fraction, 5 fractions a week, with a total dose of 4140cgy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

Chemotherapy:Patients will be concurrently administered with irradiation every 4 weeks with PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) for 2 cycles.

Surgery:Patients will receive operation 4-8 weeks after chemoradiotherapy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Optimum Design of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental arm
PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) every 4 weeks for 2 cycles concurrently with three-dimensional radiation therapy or intensity-modulated radiotherapy followed by surgery 4-8weeks after neoadjuvant therapy in a standard manner.
Radiation: radiotherapy
The clinical target volume of radiotherapy only includes the visible tumor and lymph nodes and the investigators wouldn't do any prophylactic radiation treatment.

Procedure: Surgery
Surgery would be done 4-8 weeks after neoadjuvant chemoradiotherapy.




Primary Outcome Measures :
  1. Percentage of patients completing adjuvant chemoradiotherapy and surgery [ Time Frame: 4-8weeks after surgery ]

Secondary Outcome Measures :
  1. Percentage of R0 resection [ Time Frame: 4-8weeks after surgery ]
  2. Percentage of pathological complete response [ Time Frame: 4-8weeks after surgery ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable.
  2. Patients must not have received any prior anticancer therapy.
  3. More than 6 months of expected survival.
  4. Age ranges from 18 to 70 years.
  5. 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.
  6. Karnofsky performance status (KPS) of 90 or more.
  7. Signed informed consent document on file.

Exclusion Criteria:

  1. Patients are diagnosed or suspected to be allergic to cisplatin or 5-Fu.
  2. Patients with concomitant hemorrhagic disease.
  3. Pregnant or breast feeding.
  4. Inability to use gastric conduit after esophagectomy because of a prior surgery.
  5. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
  6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

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): NCT02938195


Contacts
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Contact: Jun Liu, Doctor +862122200000 ext 3602 drjunliu@qq.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Jun Liu, Doctor    +862122200000 ext 3602    drjunliu@qq.com   
Sponsors and Collaborators
Shanghai Chest Hospital
Investigators
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Study Director: Xiaolong Fu, Ph.D Department of Radiation Oncology,Shanghai Chest Hospital

Publications:

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Responsible Party: Jun Liu, associate chief physician, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT02938195     History of Changes
Other Study ID Numbers: SCHEC001
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell