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NCT Number: NCT02979691

Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01

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

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Key information

Conditions

Esophagus Cancer Chemoradiation Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophagogastric Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Radiotherapy; Complications

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SIB-IMRT

Radiation

S-1

Drug

Primary outcomes

  1. Overall survival

    Time frame: 1 year

Secondary outcomes

  1. Comprehensive geriatric assessment

    Time frame: Baseline

    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.

  2. Remission rate of dysphagia

    Time frame: Change from baseline to 1 month after treatment

  3. Progression free survival

    Time frame: 1 year

  4. Time of locoregional control and failure site within or outside radiation field

    Time frame: 1 year

  5. Radiotherapy toxicities

    Time frame: 2 months

  6. Chemoradiotherapy toxicities

    Time frame: 2 months

Other outcomes

  1. Analysis of relationship between dosimetric parameters of radiation technique and acute or late side effects

    Time frame: 6 months

  2. CT/MRI Texture Features in evaluating the tumor response and prognosis

    Time frame: Change from baseline to 1 month after treatment

  3. Clinical target contouring guided by MRI or CT simulation

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Collaborators

  • 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

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 2, 2016
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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