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Phase III Study of Simultaneous Integrated Boost Radiotherapy (SIB-IMRT) With or Without Concurrent Chemotherapy for Locally Advanced Esophageal Cancer - 3JECROG-P02

This study is currently recruiting participants.
Verified October 2017 by Zefen Xiao, Chinese Academy of Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT03308552
First Posted: October 12, 2017
Last Update Posted: October 12, 2017
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.
Collaborators:
Hebei Medical University Fourth Hospital
Tianjin Medical University Cancer Institute and Hospital
Anyang Tumor Hospital
The First Affiliated Hospital with Nanjing Medical University
Affiliated Hospital of Hebei University
Fujian Cancer Hospital
Sichuan Cancer Hospital and Research Institute
Information provided by (Responsible Party):
Zefen Xiao, Chinese Academy of Medical Sciences
  Purpose
This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for locally advanced esophageal carcinoma.

Condition Intervention Phase
Esophageal Neoplasms Radiation: SIB-IMRT Drug: Paclitaxel Drug: Platinum-Based Drug Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Inoperable Esophageal Cancer Based on Involved Sites of Regional Lymph Node Matastasis

Resource links provided by NLM:


Further study details as provided by Zefen Xiao, Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 1 year ]
  • Progression-free survival (PFS) [ Time Frame: 2 year ]
  • Local recurrence-free rate(LRFS) [ Time Frame: 1 year ]
  • Local recurrence-free rate(LRFS) [ Time Frame: 2 year ]

Secondary Outcome Measures:
  • overall survival(OS) [ Time Frame: 1 year ]
  • overall survival(OS) [ Time Frame: 2 year ]
  • Completion Rate [ Time Frame: up to 2 year ]
    the completion rate of each arm

  • Adverse events [ Time Frame: up to 5 years ]

Estimated Enrollment: 163
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: August 30, 2021
Estimated Primary Completion Date: August 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SIB-IMRT combined chemotherapy followed by chemotherapy

SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.

Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days.

Radiation: SIB-IMRT
PTV:50.4Gy/28f, PGTV:59.92Gy/28f
Drug: Paclitaxel
45 to 50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Drug: Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Drug: Paclitaxel
150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Drug: Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 80mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Placebo Comparator: SIB-IMRT Alone followed by chemotherapy
SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
Radiation: SIB-IMRT
PTV:50.4Gy/28f, PGTV:59.92Gy/28f
Drug: Paclitaxel
150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Drug: Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 80mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age≤70
  • Diagnosis of clinical stage T2-4N0-1M1(According to UICC 2002)
  • A untreated squamous esophageal carcinoma
  • Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
  • Adequate organ function
  • No known history of drug allergy
  • Blood routine examination : WBC≥4.0
  • hepatic and renal function are normal

Exclusion Criteria:

  • Age> 70 or ≤ 16
  • Already received the treatment of chemotherapy or radiotherapy
  • Pregnant or lactating females
  • Known drug allergy
  • Without agreement of informed consent form
  • Insufficient hepatorenal function or Blood routine examination
  • Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
  Contacts and Locations
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): NCT03308552


Contacts
Contact: Zefen Xiao, MD 8610-87787643 xiaozefen@sina.com
Contact: Xiao Chang, MD 86-18801067622 changxiaojlu@163.com

Locations
China, Beijing
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) Recruiting
Beijing, Beijing, China, 100021
Contact: Zefen Xiao, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Hebei Medical University Fourth Hospital
Tianjin Medical University Cancer Institute and Hospital
Anyang Tumor Hospital
The First Affiliated Hospital with Nanjing Medical University
Affiliated Hospital of Hebei University
Fujian Cancer Hospital
Sichuan Cancer Hospital and Research Institute
Investigators
Principal Investigator: Zefen Xiao, MD The Department of Radiation Oncology ,Cancer Institute & Hospital,Chinese Academy of Medical Science
  More Information

Responsible Party: Zefen Xiao, MD, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03308552     History of Changes
Other Study ID Numbers: 17-113/1369
First Submitted: October 8, 2017
First Posted: October 12, 2017
Last Update Posted: October 12, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action