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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02979691
Other study ID # 3JECROG P-01
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date October 2016
Est. completion date April 2020

Study information

Verified date July 2020
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date April 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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

Study Design


Intervention

Radiation:
SIB-IMRT

Drug:
S-1


Locations

Country Name City State
China Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) Beijing

Sponsors (11)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences Affiliated Hospital of Hebei University, Anyang Tumor Hospital, Fujian Cancer Hospital, Hebei Medical University Fourth Hospital, Sichuan Cancer Hospital and Research Institute, Tengzhou Central People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital with Nanjing Medical University, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Analysis of relationship between dosimetric parameters of radiation technique and acute or late side effects 6 months
Other CT/MRI Texture Features in evaluating the tumor response and prognosis Change from baseline to 1 month after treatment
Other Clinical target contouring guided by MRI or CT simulation Baseline
Primary Overall survival 1 year
Secondary Comprehensive geriatric assessment A comprehensive geriatric assessment (CGA) is a multidisciplinary evaluation in which multiple problems of older persons are described.It consists several questionnaires used to assess an older individual's functional status,comorbid medical condition,cognition, psychologic state, social support, and nutritional status,etc. Baseline
Secondary Remission rate of dysphagia Change from baseline to 1 month after treatment
Secondary Progression free survival 1 year
Secondary Time of locoregional control and failure site within or outside radiation field 1 year
Secondary Radiotherapy toxicities 2 months
Secondary Chemoradiotherapy toxicities 2 months
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