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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

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.

Condition or disease Intervention/treatment Phase
Esophagus Cancer Esophagogastric Junction Cancer Chemoradiation Targeted Therapy Immunotherapy Chemotherapy Effect Radiation: Radiotherapy Drug: Platinum based chemotherapy Drug: Paclitaxel based chemotherapy Drug: Immunotherapy Drug: 5-FU Analog based chemotherapy Drug: Nimotuzumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer
Actual Study Start Date : January 1, 2002
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Definitive Chemoradiation
This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.
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: 5-FU Analog based chemotherapy
W1-5 qW or d1-14, q3W according to physician's preference

Experimental: Chemoradiation Combined With Immunotherapy/targeting agents
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 1 year, 2 year, 3 year, 5 year ]
  2. Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy [ Time Frame: 3 months ]
  3. 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).

  4. R0 resection rate [ Time Frame: 3 months ]
  5. Locoregional recurrence free survival [ Time Frame: 1 year, 2 year, 3 year, 5 year ]
  6. Distant metastasis free survival [ Time Frame: 1 year, 2 year, 3 year, 5 year ]

Other Outcome Measures:
  1. 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 ]
  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04821778


Contacts
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Contact: Xin Wang, MD +861013311583220 beryl_wx2000@163.com

Locations
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China
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) Recruiting
Beijing, China, 100021
Contact: Xin Wang, MD    +861013311583220    beryl_wx2000@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
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Responsible Party: Wang Xin, Principal Investigator, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04821778    
Other Study ID Numbers: NCC2722
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Nimotuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological