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Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer

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ClinicalTrials.gov Identifier: NCT04821778
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Wang Xin, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE March 15, 2021
First Posted Date  ICMJE March 30, 2021
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE January 1, 2002
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2021)
Overall survival [ Time Frame: 5 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2021)
  • Progression free survival [ Time Frame: 1 year, 2 year, 3 year, 5 year ]
  • Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy [ Time Frame: 3 months ]
  • Pathological response rate [ Time Frame: 3 months ]
    Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
  • R0 resection rate [ Time Frame: 3 months ]
  • Locoregional recurrence free survival [ Time Frame: 1 year, 2 year, 3 year, 5 year ]
  • Distant metastasis free survival [ Time Frame: 1 year, 2 year, 3 year, 5 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 26, 2021)
  • Analysis of correlation between radiomics signature extracted by LASSO and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 1 year, 2 year, 3 year, 5 year ]
  • Radiomics analysis [ Time Frame: 1 year, 2 year, 3 year, 5 year ]
    Analysis of correlation between radiomics signature extracted by LASSO and the rate of participants who achieve pathological complete response (pCR) and the overall survival based on MRI and CT simulation.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer
Official Title  ICMJE Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer
Brief Summary Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these patients. Morerover, molecular targeting agents does not show clear efficacy in EC up to now. Nowadays, the pace of development of cancer immunotherapies is accelerating. Clinical evidence of the efficacy of immune checkpoint inhibitors and adoptive immunotherapies herald the onset of a new era in cancer immunotherapy. There have also been recent developments to provide a promising frontier in extending the use of immunotherpay or targeting agents to radiotherapy. The purpose of this study was to explore the optimal treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with unresectable esophageal or esophagogastric junction cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Esophagus Cancer
  • Esophagogastric Junction Cancer
  • Chemoradiation
  • Targeted Therapy
  • Immunotherapy
  • Chemotherapy Effect
Intervention  ICMJE
  • Radiation: Radiotherapy
    50-66Gy/1.8-2.2Gy/25-30f
  • Drug: Platinum based chemotherapy
    q1-3W according to physician's preference
  • Drug: Paclitaxel based chemotherapy
    q1-3W according to physician's preference
  • Drug: Immunotherapy
    Anti-PD-1/PD-L1 Antibody
  • Drug: 5-FU Analog based chemotherapy
    W1-5 qW or d1-14, q3W according to physician's preference
  • Drug: Nimotuzumab
    200-400mg, d1,qW
Study Arms  ICMJE
  • Placebo Comparator: Definitive Chemoradiation
    This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.
    Interventions:
    • Radiation: Radiotherapy
    • Drug: Platinum based chemotherapy
    • Drug: Paclitaxel based chemotherapy
    • Drug: 5-FU Analog based chemotherapy
  • Experimental: Chemoradiation Combined With Immunotherapy/targeting agents
    This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
    Interventions:
    • Radiation: Radiotherapy
    • Drug: Platinum based chemotherapy
    • Drug: Paclitaxel based chemotherapy
    • Drug: Immunotherapy
    • Drug: 5-FU Analog based chemotherapy
    • Drug: Nimotuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2021)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥18 years;
  • Esophageal or Esophagogastric cancer;
  • Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa(AJCC 8th);
  • Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences;
  • ECOG PS score: 0~1;
  • Estimated survival time ≥3 months;
  • Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit;
  • Informed consent;

Exclusion Criteria:

  • With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc;
  • Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer;
  • Existing active infection such as active tuberculosis and hepatitis;
  • History of myocardial infarction within the past 6 months or history of ventricular arrhythmia;
  • Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin;
  • Participation in other clinical trials currently or within 4 weeks of selection;
  • Pregnant or lactating females;
  • Absence of medical records.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xin Wang, MD +861013311583220 beryl_wx2000@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04821778
Other Study ID Numbers  ICMJE NCC2722
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wang Xin, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese Academy of Medical Sciences
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP