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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Reduced dose

Conventional dose

Chemotherapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ).
Age <18 or >80years.
Pregnancy or lactation.
History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
With sever infection and internal disease.
Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment.

Sites / Locations

Taizhou Central HospitalRecruiting
Taizhou HospitalRecruiting
Taizhou Cancer HospitalRecruiting
Taizhou Enze Medical Center(Group) Enze HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reduced dose group

Conventional dose group

Arm Description

The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.

The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Incidence of treatment related acute complications

treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.

Incidence of treatment related late complications

treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.

Overall response rate

efficacy will be measured by PERCIST1.0 and RECIST1.1 criteria.

Full Information

NCT ID

NCT04813705

First Posted

March 22, 2021

Last Updated

February 17, 2023

Sponsor

Taizhou Hospital

Collaborators

Taizhou Enze Medical Center (Group) Enze Hospital, Taizhou Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04813705

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taizhou Hospital

Collaborators

Taizhou Enze Medical Center (Group) Enze Hospital, Taizhou Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Reduced dose group

Arm Type

Experimental

Arm Description

The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.

Arm Title

Conventional dose group

Arm Type

Active Comparator

Arm Description

The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.

Intervention Type

Radiation

Intervention Name(s)

Reduced dose

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Conventional dose

Intervention Description

The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Local-regional recurrence free survival (LRFS)

Description

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.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

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.

Time Frame

5 years

Title

Progression free survival (PFS)

Description

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.

Time Frame

5 years

Title

Distant metastasis-free survival (DMFS)

Description

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.

Time Frame

5 years

Title

Incidence of treatment related acute complications

Description

treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.

Time Frame

up to 3 months

Title

Incidence of treatment related late complications

Description

treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.

Time Frame

up to 5 years

Title

Overall response rate

Description

efficacy will be measured by PERCIST1.0 and RECIST1.1 criteria.

Time Frame

up to 5 years

Other Pre-specified Outcome Measures:

Title

Biomarkers

Description

The correlation between the radiotherapy dose with biomarkers such as peripheral blood lymphocyte and EBV-DNA.

Time Frame

up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathology confirmed nasopharyngeal squamous cell carcinoma. Stage I-IVA（8thAJCC/UICC staging system). Aged 18-80 years. KPS≥70. Have measurable lesions on 18F-FDG PET/CT before treatment. HGB≥90 g/L，ANC≥1.5×109 /L，PLT≥80×109 /L. ALT,AST<2.5 fold of ULN；TBIL<2.0×ULN. CCR≥60ml/min or Cr<1.5×ULN. Signed informed consent. Have follow up condition. Exclusion Criteria: Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ). Age <18 or >80years. Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. With sever infection and internal disease. Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haihua Yang, MD

Phone

13819639006

yhh93181@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haihua Yang, MD

Organizational Affiliation

Taizhou Enze Medical Center (Group) Enze Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taizhou Central Hospital

City

Taizhou

State/Province

Zhejiang

ZIP/Postal Code

317000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shenpeng Ying

Phone

13957608158

First Name & Middle Initial & Last Name & Degree

Shenpeng Ying

First Name & Middle Initial & Last Name & Degree

Bo Wu

Facility Name

Taizhou Hospital

City

Taizhou

State/Province

Zhejiang

ZIP/Postal Code

317000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haihua Yang, MD

Phone

+86 13819639006

yhh93181@hotmail.com

First Name & Middle Initial & Last Name & Degree

Weijun Ding

First Name & Middle Initial & Last Name & Degree

Jian Zhu

Facility Name

Taizhou Cancer Hospital

City

Taizhou

State/Province

Zhejiang

ZIP/Postal Code

317500

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guangxian You, MD

Phone

13676668511

First Name & Middle Initial & Last Name & Degree

Guangxian You

First Name & Middle Initial & Last Name & Degree

Linggang Zhu

Facility Name

Taizhou Enze Medical Center(Group) Enze Hospital

City

Taizhou

State/Province

Zhejiang

ZIP/Postal Code

318050

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haihua Yang, MD

Phone

+86 13819639006

yhh93181@hotmail.com

First Name & Middle Initial & Last Name & Degree

Haihua Yang, MD

First Name & Middle Initial & Last Name & Degree

Xiate Zhou, MD

12. IPD Sharing Statement

Learn more about this trial

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

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