Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04813705
Recruitment Status : Not yet recruiting
First Posted : March 24, 2021
Last Update Posted : April 1, 2021
Sponsor:
Collaborators:
Taizhou Enze Medical Center (Group) Enze Hospital
Taizhou Central Hospital
Taizhou Cancer Hospital
Information provided by (Responsible Party):
Haihua Yang, Taizhou Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to explore whether 18F-FDG PET/CT guided reduced-dose radiotherapy would maintain survival outcomes in nasopharyngeal carcinoma (NPC) patients.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: Reduced dose Radiation: Conventional dose Drug: Chemotherapy Phase 2

Detailed Description:
Enrolled patients with complete metabolic response (CMR) and more than 70% partial metabolic response (PMR) according to PERCIST criteria at the 25th fraction will receive intensity modulated radiation therapy (IMRT) of reduced-dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions), for those who with ≤70% PMR will receive conventional dose (prescribed dose, 70Gy, 2.12 Gy per fractions, 33 fractions).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Reduced dose group
The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
 Radiation: Reduced dose
The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.

Drug: Chemotherapy
The patients with stage II will receive concurrent cisplatin during Intensity modulated radiotherapy (IMRT), and stage III-IVA patients will receive platinum based induction chemotherapy every 21 days for at least two cycles followed by concurrent cisplatin during IMRT.
Active Comparator: Conventional dose group
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
 Radiation: Conventional dose
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.

Drug: Chemotherapy
The patients with stage II will receive concurrent cisplatin during Intensity modulated radiotherapy (IMRT), and stage III-IVA patients will receive platinum based induction chemotherapy every 21 days for at least two cycles followed by concurrent cisplatin during IMRT.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Local-regional recurrence free survival (LRFS) [ Time Frame: 5 years ]
    The LRFS is evaluated and calculated from the date of initiation of treatment until the day of first locoregional relapse or until the date of the last follow-up visit.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 5 years ]
    The OS was defined as the duration from the date of of initiation of treatment to the date of death from any cause or censored at the date of the last follow-up.

  2. Progression free survival (PFS) [ Time Frame: 5 years ]
    Progress-free survival is calculated from the date of initiation of treatment to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.

  3. Distant metastasis-free survival (DMFS) [ Time Frame: 5 years ]
    The DMFS is evaluated and calculated from the date of initiation treatment until the day of first distant metastases or until the date of the last follow-up visit.

  4. Incidence of treatment related acute complications [ Time Frame: up to 3 months ]
    treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.

  5. Incidence of treatment related late complications [ Time Frame: up to 5 years ]
    treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.

  6. Overall response rate [ Time Frame: up to 5 years ]
    efficacy will be measured by PERCIST1.0 and RECIST1.1 criteria.


Other Outcome Measures:
  1. Biomarkers [ Time Frame: up to 5 years ]
    The correlation between the radiotherapy dose with biomarkers such as peripheral blood lymphocyte and EBV-DNA.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathology confirmed nasopharyngeal squamous cell carcinoma.
  2. Stage I-IVA（8thAJCC/UICC staging system).
  3. Aged 18-80 years.
  4. KPS≥70.
  5. Have measurable lesions on 18F-FDG PET/CT before treatment.
  6. HGB≥90 g/L，ANC≥1.5×109 /L，PLT≥80×109 /L.
  7. ALT,AST<2.5 fold of ULN；TBIL<2.0×ULN.
  8. CCR≥60ml/min or Cr<1.5×ULN.
  9. Signed informed consent.
  10. Have follow up condition.

Exclusion Criteria:

  1. Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ).
  2. Age <18 or >80years.
  3. Pregnancy or lactation.
  4. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  6. With sever infection and internal disease.
  7. Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04813705


Contacts
Layout table for location contacts
Contact: Haihua Yang, MD 13819639006 yhh93181@hotmail.com

Locations
Layout table for location information
China, Zhejiang
Taizhou Central Hospital
Taizhou, Zhejiang, China, 317000
Contact: Shenpeng Ying    13957608158      
Principal Investigator: Shenpeng Ying         
Sub-Investigator: Bo Wu         
Taizhou Hospital
Taizhou, Zhejiang, China, 317000
Contact: Haihua Yang, MD    +86 13819639006    yhh93181@hotmail.com   
Principal Investigator: Weijun Ding         
Sub-Investigator: Jian Zhu         
Taizhou Cancer Hospital
Taizhou, Zhejiang, China, 317500
Contact: Guangxian You, MD    13676668511      
Principal Investigator: Guangxian You         
Sub-Investigator: Linggang Zhu         
Taizhou Enze Medical Center(Group) Enze Hospital
Taizhou, Zhejiang, China, 318050
Contact: Haihua Yang, MD    +86 13819639006    yhh93181@hotmail.com   
Principal Investigator: Haihua Yang, MD         
Sub-Investigator: Xiate Zhou, MD         
Sponsors and Collaborators
Taizhou Hospital
Taizhou Enze Medical Center (Group) Enze Hospital
Taizhou Central Hospital
Taizhou Cancer Hospital
Investigators
Layout table for investigator information
Principal Investigator: Haihua Yang, MD Taizhou Enze Medical Center (Group) Enze Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Haihua Yang, Head of Department of Radiation Oncology, Taizhou Hospital
ClinicalTrials.gov Identifier: NCT04813705    
Other Study ID Numbers: PRR-202103
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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