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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04813705
• Other study ID #: PRR-202103
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: June 30, 2029

Study information

• Verified date: February 2023
• Source: Taizhou Hospital
• Contact: Haihua Yang, MD
• Phone: 13819639006
• Email: yhh93181[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• Reduced dose
The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
• 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.

Locations

Country	Name	City	State
China	Taizhou Cancer Hospital	Taizhou	Zhejiang
China	Taizhou Central Hospital	Taizhou	Zhejiang
China	Taizhou Enze Medical Center(Group) Enze Hospital	Taizhou	Zhejiang
China	Taizhou Hospital	Taizhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Taizhou Hospital	Taizhou Cancer Hospital, Taizhou Enze Medical Center (Group) Enze Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers	The correlation between the radiotherapy dose with biomarkers such as peripheral blood lymphocyte and EBV-DNA.	up to 5 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall response rate	efficacy will be measured by PERCIST1.0 and RECIST1.1 criteria.	up to 5 years