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Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT04851132
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Zhouguang Hui, M.D., Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE April 5, 2021
First Posted Date  ICMJE April 20, 2021
Last Update Posted Date June 22, 2021
Actual Study Start Date  ICMJE March 11, 2021
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2021)
Progression-free survival (PFS) [ Time Frame: 1-year ]
PFS was assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1. Progression-free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2021)
  • Overall survival (OS) [ Time Frame: 1-, 2- and 3-year ]
    Overall survival defined as the time from enrollment to death due to any cause.
  • Progression-free survival (PFS) [ Time Frame: 2- and 3-year ]
    PFS was assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1. Progression-free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.
  • Objective Response Rate (ORR) [ Time Frame: during the intervention up to 60 weeks ]
    ORR was Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
  • Disease Control Rate (DCR) [ Time Frame: during the intervention up to 60 weeks ]
    DCR was Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
  • Number of participants with an adverse event [ Time Frame: Up to 60 weeks ]
    Evaluanted by CTCAE 5.0
  • Quality of Life (QOL): questionnaire EORTC QLQ-C30 (version 3) [ Time Frame: up to 60 weeks ]
    Evaluate the quality of life via questionnaire EORTC QLQ-C30 (version 3), minimum value 30, maximum value 126, higher scores mean a worse outcome.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 16, 2021)
Quality of Life (QOL): questionnaire EORTC QLQ-OES18 [ Time Frame: up to 60 weeks ]
Evaluate the quality of life via questionnaire EORTC QLQ-OES18, minimum value 18, maximum value 72, higher scores mean a better outcome.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma
Official Title  ICMJE Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial
Brief Summary The incidence and mortality of esophageal cancer are at the forefront in China, among which the elderly patients account for a large proportion. Concurrent chemoradiotherapy is the standard treatment for inoperable locally advanced esophageal cancer. Most elderly patients with esophageal cancer cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
RT + Durvalumab
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma
Intervention  ICMJE
  • Radiation: Radiotherapy
    IMRT (Intensity Modulated RT) or 3D-CRT (three-dimensional conformal radiotherapy); 95% PGTV 59.92Gy/2.14Gy/28f; 95% GTVnd 59.92Gy/2.14Gy/28f; 95% PTV 50.40Gy/1.80Gy/28f; 5 days a week; 6 weeks.
  • Drug: Durvalumab
    Durvalumab 1000 mg, intravenously (IV), on Day 1 of radiotherapy, every 3 weeks for up to 18 administrations.
Study Arms  ICMJE Experimental: Exprimental Arm
IMRT plus Durvalumab
Interventions:
  • Radiation: Radiotherapy
  • Drug: Durvalumab
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: April 16, 2021)
33
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 70-85 years old, both men and women
  2. Histologically confirmed esophageal squamous cell carcinoma located in thoracic segment, treatment naive
  3. Stage cT2-4aNanyM0 (AJCC 8 TNM classification)
  4. Unresectable, unable to tolerate or refuse surgery and concurrent chemoradiotherapy
  5. ECOG PS 0-2
  6. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  7. No severe abnormalities of the Hematologic system, heart, lung, liver, kidney, and immunodeficiency
  8. Adequate bone marrow and organ function as defined below (excluding the use of any blood components and cell growth factors within 7 days):

    • Absolute neutrophil count≥1,500/mm3
    • Platelets ≥ 100,000/mm3
    • Hemoglobin ≥ 5.6 mmol/L (9g/dL)
    • Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥50 mL/min by Cockcroft-Gault estimation
    • Total bilirubin ≤ 1.5 x ULN
    • ALT and AST ≤ 2.5 x ULN
    • Proteinuria < 2+, for subjects with urine protein ≥ 2 + at baseline, urine samples should be collected within 24 hours and urine protein in 24 hours should be ≤ 1g
  9. INR or PT or aPTT ≤ 1.5 x ULN
  10. Life expectancy more than 6 months
  11. Ability to understand and willingness to sign an IRB approved written informed consent document, and capable of proper therapeutic compliance, and accessible to correct follow-up

Exclusion Criteria:

  1. Complete esophageal obstruction that unable to eat fluid and cannot provide necessary nutrition through nasal feeding
  2. Patients with obvious ulcer or esophageal perforation or hematemesis
  3. Placement of esophagotracheal stents
  4. Has a history or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumonoconiosis, drug-associated pneumonia, severe impairment of pulmonary function
  5. Has had major surgery within 28 days prior to the start of the treatment
  6. Immunosuppressive drugs used within 4 weeks prior to the initial study treatment, excluding local glucocorticoids, or systemic glucocorticoids at physiological doses (i.e., no more than 10 mg/ day of prednisone or equivalent doses of other glucocorticoids);
  7. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, glomerulonephritis, thyroiditis (patients with vitiligo or asthma has been completely relieved in childhood, and do not need any intervention during adulthood can be included; patients with type I diabetes with good insulin control can also be included; hypothyroidism caused by autoimmune thyroiditis requiring hormone replacement therapy can also be included)
  8. Has had congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (HCV-RNA ≥ 103 copies/ml; For chronic hepatitis B virus carriers, HBV viral load must be < 2000 IU/ml (< 104 copies / ml), and must receive antiviral therapy at the same time before they can be enrolled
  9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
  10. Uncontrolled clinically significant disease, including active infection, uncontrolled hypertension, unstable angina pectoris, angina within the past 3 months, heart failure > NYHA II, myocardial infarction within the past 6 months, severe arrhythmias requirement for treatment or intervention, liver/kidney or metabolic disease
  11. System infections that require treatment
  12. Received a live vaccine within 4 weeks of the first dose of study medication
  13. Synchronous or metachronous second primary malignancy. Participants with basal cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded from the study
  14. Patients who have participated in other clinical trials within 30 days
  15. Drug addiction, chronic alcoholism and AIDS
  16. Patients with uncontrollable seizures or loss of self-control due to mental illness
  17. Those with a history of severe allergy or specific physique
  18. The investigators judge not suitable for inclusion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04851132
Other Study ID Numbers  ICMJE NCC2840
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
Plan to Share IPD: No
Responsible Party Zhouguang Hui, M.D., 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 June 2021

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