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Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P02

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ClinicalTrials.gov Identifier: NCT03308552
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : November 6, 2017
Sponsor:
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

Brief Summary:
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 esophageal carcinoma with limited lymph node metastasis.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Radiation: SIB-IMRT Drug: Paclitaxel Drug: Platinum-Based Drug Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel 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 Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P02
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
45-50 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, 4 cycles, 1-3 months after completion of radiotherapy

Drug: Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 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, 4 cycles, 1-3 months after completion of radiotherapy

Drug: Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy




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

Secondary Outcome Measures :
  1. Progress free survival(PFS) [ Time Frame: 1 year ]
  2. Progress free survival(PFS) [ Time Frame: 2 year ]
  3. Progress free survival(PFS) [ Time Frame: 3 year ]
  4. Local recurrence-free rate(LRFS) [ Time Frame: 1 year ]
  5. Local recurrence-free rate(LRFS) [ Time Frame: 2 year ]
  6. Local recurrence-free rate(LRFS) [ Time Frame: 3 year ]
  7. Completion Rate [ Time Frame: up to 2 year ]
    the completion rate of each arm

  8. Adverse events [ Time Frame: up to 5 year ]


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
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 < 18
  • 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.

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

Responsible Party: Zefen Xiao, Principal Investigator, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03308552     History of Changes
Other Study ID Numbers: 3JECROG-P02
First Posted: October 12, 2017    Key Record Dates
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