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

A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Radiation: Reduced dose; Drug: Chemotherapy; Radiation: Conventional dose

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 Type: Interventional
• Enrollment (Anticipated): 93
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Haihua Yang, MD; Phone Number: 13819639006; Email: yhh93181@hotmail.com

Study Locations

• China
  • Zhejiang
    • Taizhou, Zhejiang, China, 317000
      • Recruiting
      • Taizhou Hospital
      • Contact: Haihua Yang, MD; Phone Number: +86 13819639006; Email: yhh93181@hotmail.com
      • Principal Investigator: Weijun Ding
      • Sub-Investigator: Jian Zhu
    • Taizhou, Zhejiang, China, 317000
      • Recruiting
      • Taizhou Central Hospital
      • Contact: Shenpeng Ying; Phone Number: 13957608158
      • Principal Investigator: Shenpeng Ying
      • Sub-Investigator: Bo Wu
    • Taizhou, Zhejiang, China, 317500
      • Recruiting
      • Taizhou Cancer Hospital
      • Contact: Guangxian You, MD; Phone Number: 13676668511
      • Principal Investigator: Guangxian You
      • Sub-Investigator: Linggang Zhu
    • Taizhou, Zhejiang, China, 318050
      • Recruiting
      • Taizhou Enze Medical Center(Group) Enze Hospital
      • Contact: Haihua Yang, MD; Phone Number: +86 13819639006; Email: yhh93181@hotmail.com
      • Principal Investigator: Haihua Yang, MD
      • Sub-Investigator: Xiate Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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.; Radiation: Conventional dose; The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local-regional recurrence free survival (LRFS)	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	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.	5 years
Progression free survival (PFS)	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.	5 years
Distant metastasis-free survival (DMFS)	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.	5 years
Incidence of treatment related acute complications	treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.	up to 3 months
Incidence of treatment related late complications	treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.	up to 5 years
Overall response rate	efficacy will be measured by PERCIST1.0 and RECIST1.1 criteria.	up to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	The correlation between the radiotherapy dose with biomarkers such as peripheral blood lymphocyte and EBV-DNA.	up to 5 years

Collaborators and Investigators

• Sponsor: Taizhou Hospital
• Collaborators: Taizhou Enze Medical Center (Group) Enze Hospital; Taizhou Cancer Hospital
• Investigators: Principal Investigator: Haihua Yang, MD, Taizhou Enze Medical Center (Group) Enze Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2029

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: PRR-202103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No