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Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02384811
Recruitment Status : Active, not recruiting
First Posted : March 10, 2015
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Jiaqing Xiang, Fudan University

Brief Summary:
The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Radiation: radiation Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal
Actual Study Start Date : December 2014
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiation group
Radiation therapy
Radiation: radiation

A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks.

The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.





Primary Outcome Measures :
  1. Local control rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 year ]
  2. Safety: Frequencies of treatment-related adverse event categories by NCI-CTC [ Time Frame: 3 months ]
    Frequencies of treatment-related adverse event categories by NCI-CTC including Esophagitis,Pneumonitis/Bronchitis,Skin reaction in radiation fields,Nausea/vomiting,Leucopenia,Thrombocytopenia,Anemia,Fatigue.



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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:

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75;ECOG 0-2
  • Esophageal squamous cell carcinoma , radical surgery ≤3 months,R0 resection. The operative incision healed well.
  • T3-4N0M0, T1-4N1-3M0 (according to AJCC2009)
  • No radiotherapy, chemotherapy or other treatments pre(post)surgery
  • PS ECOG 0-2
  • Life expectancy of more than 3 months
  • Hemoglobin(Hb)≥9 g/dL • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 109/L • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN • Renal function: creatinine < 1.5 x ULN
  • No immuno-deficiency
  • Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

  • Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis
  • Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
  • Participation in other interventional clinical trials within 30 days
  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
  • Drug addiction, Alcoholism or AIDS
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  • Unsuitable to be enrolled in the trial in the opinion of the investigators

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): NCT02384811


Locations
China, Shanghai
Shanghai Cancer Center
Shanghai, Shanghai, China, 200000
Cancer hospital Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jia-qing Xiang, M.M Fudan University

Responsible Party: Jiaqing Xiang, director, Fudan University
ClinicalTrials.gov Identifier: NCT02384811     History of Changes
Other Study ID Numbers: 2014-86-882
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017

Keywords provided by Jiaqing Xiang, Fudan University:
Esophageal squamous cell carcinoma
postoperative radiotherapy

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