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

Phase 2

Recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Reduced dose; Radiation: Conventional dose; Drug: Chemotherapy

• Registration Number: NCT04813705
• Lead Sponsor: Taizhou Hospital

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.

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 Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2022-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21
• Primary Completion: 2024-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reduced dose group	Reduced dose	The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
Conventional dose group	Chemotherapy	The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
Reduced dose group	Chemotherapy	The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
Conventional dose group	Conventional dose	The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.

Primary Outcome Measures

Name	Time	Method
Local-regional recurrence free survival (LRFS)	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

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

Trial Locations

Locations (4)

Taizhou Cancer Hospital; 🇨🇳 Taizhou, Zhejiang, China

Taizhou Hospital; 🇨🇳 Taizhou, Zhejiang, China

Taizhou Central Hospital; 🇨🇳 Taizhou, Zhejiang, China

Taizhou Enze Medical Center(Group) Enze Hospital; 🇨🇳 Taizhou, Zhejiang, China