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Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P03

This study is currently recruiting participants.
Verified November 2017 by Zefen Xiao, Chinese Academy of Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT03328234
First Posted: November 1, 2017
Last Update Posted: November 6, 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.
Information provided by (Responsible Party):
Zefen Xiao, Chinese Academy of Medical Sciences
  Purpose
The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.

Condition Intervention Phase
IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer Radiation: SIB-IMRT Drug: Paclitaxel Drug: Platinum-Based Drug Other: Elective Nodal Irradiation (ENI) Other: Involved Field Irradiation (IFI) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P03

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 1 year ]
  • Overall survival (OS) [ Time Frame: 2 year ]
  • Overall survival (OS) [ Time Frame: 3 year ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 1 year ]
  • Progression-free survival (PFS) [ Time Frame: 2 year ]
  • Progression-free survival (PFS) [ Time Frame: 3 year ]
  • Local recurrence-free rate(LRFS) [ Time Frame: 1 year ]
  • Local recurrence-free rate(LRFS) [ Time Frame: 2 year ]
  • Local recurrence-free rate(LRFS) [ Time Frame: 3 year ]
  • Completion Rate [ Time Frame: up to 2 year ]
  • Adverse events [ Time Frame: up to 5 year ]

Estimated Enrollment: 2
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: December 31, 2022
Estimated Primary Completion Date: August 31, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SIB-IMRT with combined chemotherapy ENI Radiation: 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.
Drug: Paclitaxel
45-50mg/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
135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Drug: Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Other: Elective Nodal Irradiation (ENI)
CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and lymph node regions at high risk.
Active Comparator: SIB-IMRT with ENI Radiation: 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.
Drug: Paclitaxel
135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Drug: Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Other: Elective Nodal Irradiation (ENI)
CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and lymph node regions at high risk.
Experimental: SIB-IMRT combined chemotherapy with IFI Radiation: 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.
Drug: Paclitaxel
45-50mg/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
135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Drug: Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Other: Involved Field Irradiation (IFI)
CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.
Experimental: SIB-IMRT with IFI Radiation: 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.
Drug: Paclitaxel
135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Drug: Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Other: Involved Field Irradiation (IFI)
CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 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): NCT03328234


Contacts
Contact: Xin Wang, MD +86-13311583220 beryl_wx2000@163.com

Locations
China
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) Recruiting
Beijing, China, 100021
Contact: Xin Wang, MD    +861013311583220    beryl_wx2000@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
  More Information

Responsible Party: Zefen Xiao, Pricipal investigator, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03328234     History of Changes
Other Study ID Numbers: 3JECROG-P03
First Submitted: October 28, 2017
First Posted: November 1, 2017
Last Update Posted: November 6, 2017
Last Verified: November 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
Lymphatic Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action