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Efficacy and Safety of Neo-CRT Followed Surgery Compared With Definitive CRT in Patients With Initial Unresectable ESO

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.
 
ClinicalTrials.gov Identifier: NCT04137679
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
Definitive chemoradiotherapy(CRT) has been regarded as a standard of care for patients with unresectable locally advanced esophageal cancer. Patients who are sensitive to CRT can achieve significantly down staging. Whether this part of patients could benefit from further surgical treatment remains unknown. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive CRT versus neo-CRT plus radical resection in patients who achieved down staging after neo-CRT for stage T4NxM0 esophageal Cancer.

Condition or disease Intervention/treatment Phase
Unresectable Esophageal Cancer Radiation: Definitive Radiochemotherapy Procedure: Neoadjuvant Radiochemotherapy followed by surgery Phase 2

Detailed Description:
  1. Compare progression-free survival (PFS) and overall survival (OS) of definitive radiochemotherapy versus(VS) neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who down stage from inoperable to operable after neoadjuvant treatment;
  2. Compare the toxic and side effects of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete remission after neoadjuvant treatment;
  3. Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection on quality of life of patients.

Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2), 1st/8th/15th/22nd day

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Neo-Radiochemotherapy Followed Surgery Compared With Definitive Radiochemotherapy in Patients With Initial Unresectable Esophageal Cancer
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Definitive Radiochemotherapy

Concurrent Radiochemotherapy:

Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.

Radiation: Definitive Radiochemotherapy
Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day

Procedure: Neoadjuvant Radiochemotherapy followed by surgery
Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.

Active Comparator: Neoadjuvant Radiochemotherapy followed by surgery

Concurrent Radiochemotherapy:

Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.

Radiation: Definitive Radiochemotherapy
Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day

Procedure: Neoadjuvant Radiochemotherapy followed by surgery
Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy

  2. Disease-free survival [ Time Frame: 3 years ]
    Compare progression-free survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy.


Secondary Outcome Measures :
  1. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: 5 years ]
    grade 3 or 4 toxicity of leukocytes, febrile neutropenia, thrombocytes, hemoglobin, nausea/vomiting, diarrhea, stomatitis, esophagitis, cardiovascular.



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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. Thoracic esophageal cancer patients or esophagogastric junction cancer patients, with locally advanced unresectable tumor, clinically identified before treatment as T4bNxM0 or lymph node metastases (LNM)invading adjacent structures according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 8th ed.
  2. Initial unresectable assessed by surgeon.
  3. Patients able to tolerate surgery.
  4. Untreated patients who have not received any antitumor therapy.
  5. Life expectancy > 6 months.
  6. Age: 18-70 years.
  7. White blood cell count ≥4.0×10^9/L, ANC(absolute neutrophil count) ≥1.5×10^9/L, thrombocyte count ≥100×10^9/L, hemoglobin ≥90 g/L; normal liver and kidney functions.
  8. WHO PS(Performance Status): 0-1.
  9. Patients who understood the study and gave signed informed consent.

Exclusion Criteria:

  1. Patients who have already received antitumor therapy, including chemotherapy, radiotherapy or surgery.
  2. Patients with hemorrhage or complicated hemorrhage.
  3. Other uncontrollable patients who are not suitable for surgery.
  4. Patients who deny to accept surgery.
  5. Pregnant or lactating women.
  6. Patients who agree without acknowledgement as a result of psychological, family or social factors.
  7. Patients with CTCAE(Common Terminology Criteria Adverse Events Version 4.0) grade ≥2 peripheral neuropathy.
  8. Patients who have ever had malignant tumors other than esophageal cancer.
  9. Patients with a history of diabetes for >10 years with unsatisfactory control of blood glucose level.
  10. Patients with serious heart, lung, liver or kidney dysfunction, hematopathy, immune system disease or cachexia who therefore cannot tolerate chemotherapy or surgery.
  11. Patients with severe infection.
  12. Patients with uncontrolled diabetes, random blood glucose > 200mg/L, fasting glucose >140mg/L.
  13. Patients with other severe disease, such as myocardial infarction in the last 6 months.
  14. Patients who participate in other clinical trials right now or in the last 4 weeks.

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): NCT04137679


Contacts
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Contact: Tian Zhang, Doctor +862223341405 839159994@qq.com

Locations
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China, Tianjin
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: QING SONG PANG, M.D    +86-22-23340123-1314    pangqingsong@yahoo.com.cn   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Study Chair: Qingsong Pang, Doctor Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT04137679    
Other Study ID Numbers: TJESO-1
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action