Clinical trial NCT03308552: Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Neoplasms
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Hebei Medical University Fourth Hospital
name: Tianjin Medical University Cancer Institute and Hospital
name: Anyang Tumor Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Affiliated Hospital of Hebei University
name: Fujian Cancer Hospital
name: Sichuan Cancer Hospital and Research Institute
First posted: 2017-10-12
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Overall survival（OS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 2 year
measure: Overall survival（OS）
timeFrame: 3 year
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Progress free survival（PFS）
timeFrame: 2 year
measure: Progress free survival（PFS）
timeFrame: 3 year
measure: Local recurrence-free rate（LRFS）
timeFrame: 1 year
measure: Local recurrence-free rate（LRFS）
timeFrame: 2 year
measure: Local recurrence-free rate（LRFS）
timeFrame: 3 year
measure: Completion Rate
timeFrame: up to 2 year
measure: Adverse events
timeFrame: up to 5 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
state: Beijing
Study officials:
affiliation: The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science
name: Zefen Xiao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.