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De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT04158518
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Chaosu Hu, Fudan University

Brief Summary:
The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: Toxicities reduced treatment Radiation: Conventional treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Toxicities reduced treatment
Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).
Radiation: Toxicities reduced treatment

Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.

Omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).

Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.


Active Comparator: Conventional treatment
Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR).
Radiation: Conventional treatment

Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.

Concurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR).

Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.





Primary Outcome Measures :
  1. DFS [ Time Frame: 3 year ]
    Disease Free Survival


Secondary Outcome Measures :
  1. OS [ Time Frame: 3 year ]
    Overall Survival



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of nasopharyngeal carcinoma
  • Stage III or IVA according to UICC/AJCC 8th staging system
  • Age ≥18
  • No prior anti-tumor treatment
  • Karnofsky Performance Score (KPS)≥70
  • Adequate blood supply
  • Informed consent obtained

Exclusion Criteria:

  • Can not take contrast-MRI imaging
  • Pregnant
  • Combined with other malignant tumor (except basal cell carcinoma of skin)

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): NCT04158518


Contacts
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Contact: Youqi Yang, MD +8613916162859 yangyq@sina.com
Contact: Xueguan Lu, MD +8618121299382 luxueguan@163.com

Locations
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China
Fudan Universtiy Shanghai Cancer Centre Not yet recruiting
Shanghai, China
Contact: Youqi Yang, MD    +8613916162859    yangyq@sina.com   
Contact: Xueguan Lu, MD    +8618121299382    luxueguan@163.com   
Sponsors and Collaborators
Chaosu Hu
Investigators
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Principal Investigator: Chaosu Hu, MD Fudan University Shanghai Cancer Centre

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Responsible Party: Chaosu Hu, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT04158518     History of Changes
Other Study ID Numbers: 2019-NPC001
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chaosu Hu, Fudan University:
Nasopharyngeal Carcinoma
De-escalation
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action