Clinical trial NCT02979691: Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01
Official title: A Phase II/III Study Comparing Simultaneous Integrated Boost (SIB) Intensity Modulated Radiation Therapy (IMRT) With S1 Based SIB-IMRT Followed by Adjuvant Chemotherapy With S1 in Elderly Patients With Esophageal or Esophagogastric Cancer (3JECROG-P01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Esophagus Cancer
Esophagogastric Junction Cancer
Radiotherapy; Complications
Chemoradiation
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: Tengzhou Central People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Sichuan Cancer Hospital and Research Institute
First posted: 2016-12-02
Enrollment: 350
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ratiotherapy alone is the current standard treatment for elderly esophageal or esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in elderly patients. This study aimed to assess the efficiency and safety of simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT followed by adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or esophagogastric cancer patients


Eligibility criteria: Inclusion Criteria:

* ≥70 years
* Esophageal or Esophagogastric cancer
* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as IIa-IVb (UICC 2002, IVb only with supraclavicular or celiac trunk lymph nodes metastasis)
* Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
* No distant metastasis other than supraclavicular lymph nodes
* No prior history of thoracic radiation
* Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
* Informed consent

Exclusion Criteria:

* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
* With any distant metastasis out of regional lymphatic drainage or in liver,lung,bone,CNS,etc
* History of allergic reactions attributed to similar chemical or biologic complex to S-1
* With esophageal fistula, perforation, cachexia prior to treatment
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* Pregnant or lactating females

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: Comprehensive geriatric assessment
timeFrame: Baseline
measure: Remission rate of dysphagia
timeFrame: Change from baseline to 1 month after treatment
measure: Progression free survival
timeFrame: 1 year
measure: Time of locoregional control and failure site within or outside radiation field
timeFrame: 1 year
measure: Radiotherapy toxicities
timeFrame: 2 months
measure: Chemoradiotherapy toxicities
timeFrame: 2 months
Other outcomes:
measure: Analysis of relationship between dosimetric parameters of radiation technique and acute or late side effects
timeFrame: 6 months
measure: CT/MRI Texture Features in evaluating the tumor response and prognosis
timeFrame: Change from baseline to 1 month after treatment
measure: Clinical target contouring guided by MRI or CT simulation
timeFrame: Baseline
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)
Study officials:
References:
citation: Wang X, Ge X, Wang X, Zhang W, Zhou H, Lin Y, Qie S, Hu M, Wang W, Liu K, Pang Q, Li M, Chen J, Liu M, Zhang K, Li L, Shi Y, Deng W, Li C, Ni W, Chang X, Han W, Deng L, Wang W, Liang J, Bi N, Zhang T, Liu W, Wang J, Zhai Y, Feng Q, Chen D, Zhou Z, Zhao Y, Sun X, Xiao Z. S-1-Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial. Front Oncol. 2020 Aug 28;10:1499. doi: 10.3389/fonc.2020.01499. eCollection 2020.
citation: Li C, Wang X, Wang X, Han C, Wang P, Pang Q, Chen J, Sun X, Wang L, Zhang W, Lin Y, Ge X, Zhou Z, Ni W, Chang X, Liang J, Deng L, Wang W, Zhao Y, Xiao Z. A multicenter phase III study comparing Simultaneous Integrated Boost (SIB) radiotherapy concurrent and consolidated with S-1 versus SIB alone in elderly patients with esophageal and esophagogastric cancer - the 3JECROG P-01 study protocol. BMC Cancer. 2019 Apr 29;19(1):397. doi: 10.1186/s12885-019-5544-1.