NCT04813705

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Timeline
38mo left

Started Jan 2022

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2022Jun 2029

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Expected
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

March 22, 2021

Last Update Submit

February 17, 2023

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Overall survival (OS)

    5 years

  • Progression free survival (PFS)

    5 years

  • Distant metastasis-free survival (DMFS)

    5 years

  • Incidence of treatment related acute complications

    up to 3 months

  • Incidence of treatment related late complications

    up to 5 years

  • +1 more secondary outcomes

Other Outcomes (1)

  • Biomarkers

    up to 5 years

Study Arms (2)

Reduced dose group

EXPERIMENTAL

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

Radiation: Reduced doseDrug: Chemotherapy

Conventional dose group

ACTIVE COMPARATOR

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

Radiation: Conventional doseDrug: Chemotherapy

Interventions

Reduced doseRADIATION

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

Reduced dose group
Conventional doseRADIATION

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

Conventional dose group
ChemotherapyDRUG

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.

Conventional dose groupReduced dose group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Taizhou Central Hospital

Taizhou, Zhejiang, 317000, China

RECRUITING

Taizhou Hospital

Taizhou, Zhejiang, 317000, China

RECRUITING

Taizhou Cancer Hospital

Taizhou, Zhejiang, 317500, China

RECRUITING

Taizhou Enze Medical Center(Group) Enze Hospital

Taizhou, Zhejiang, 318050, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Off-Label UseDrug Therapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Drug PrescriptionsTherapeutics

Study Officials

  • Haihua Yang, MD

    Taizhou Enze Medical Center Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haihua Yang, MD

CONTACT

13819639006yhh93181@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Radiation Oncology

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

January 1, 2022

Primary Completion

June 30, 2024

Study Completion (Estimated)

June 30, 2029

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

CN(4)