Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02
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
1 other identifier
interventional
164
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2017
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2017
CompletedFirst Posted
Study publicly available on registry
October 12, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedJanuary 2, 2019
December 1, 2018
2.7 years
October 8, 2017
December 29, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Overall survival（OS）
1 year
Overall survival（OS）
2 year
Overall survival（OS）
3 year
Secondary Outcomes (8)
Progress free survival（PFS）
1 year
Progress free survival（PFS）
2 year
Progress free survival（PFS）
3 year
Local recurrence-free rate（LRFS）
1 year
Local recurrence-free rate（LRFS）
2 year
- +3 more secondary outcomes
Study Arms (2)
SIB-IMRT combined chemotherapy followed by chemotherapy
ACTIVE COMPARATORSIB-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.
SIB-IMRT Alone followed by chemotherapy
PLACEBO COMPARATORSIB-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.
Interventions
PTV:50.4Gy/28f, PGTV:59.92Gy/28f
45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese Academy of Medical Scienceslead
- Hebei Medical University Fourth Hospitalcollaborator
- Tianjin Medical University Cancer Institute and Hospitalcollaborator
- Anyang Tumor Hospitalcollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Affiliated Hospital of Hebei Universitycollaborator
- Fujian Cancer Hospitalcollaborator
- Sichuan Cancer Hospital and Research Institutecollaborator
Study Sites (1)
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, Beijing Municipality, 100021, China
Related Publications (1)
Gao LR, Wang X, Han W, Deng W, Li C, Wang X, Zhao Y, Ni W, Chang X, Zhou Z, Deng L, Wang W, Liu W, Liang J, Zhang T, Bi N, Wang J, Zhai Y, Feng Q, Lv J, Li L, Xiao Z. A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol. BMC Cancer. 2020 Sep 22;20(1):901. doi: 10.1186/s12885-020-07387-y.
PMID: 32962674DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zefen Xiao, MD
The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 8, 2017
First Posted
October 12, 2017
Study Start
December 1, 2017
Primary Completion
August 30, 2020
Study Completion
August 30, 2021
Last Updated
January 2, 2019
Record last verified: 2018-12