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

ConditionNasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTaizhou Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathology confirmed nasopharyngeal squamous cell carcinoma.

Stage I-IVA（8thAJCC/UICC staging system).

Aged 18-80 years.

KPS≥70.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Reduced dose

    Radiation

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

  • Conventional dose

    Radiation

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

  • Chemotherapy

    Drug

    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.

Treatment groups

93 Participants
are divided into 2 treatment groups
Group A: Reduced dose groupExperimental treatment 2 interventions
Group B: Conventional dose groupActive comparator 2 interventions

Trial outcomes

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.

Time frame
5 years

Secondary outcomes

1

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.

Time frame
5 years
2

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.

Time frame
5 years
3

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.

Time frame
5 years
4

Incidence of treatment related acute complications

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

Time frame
up to 3 months

Other outcomes

1

Biomarkers

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

Time frame
up to 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taizhou Hospital

Lead sponsor

Taizhou Enze Medical Center Group

Collaborator

Taizhou Cancer Hospital

Collaborator

Source ClinicalTrials.gov
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