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NCT Number: NCT04813705

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

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taizhou Cancer Hospital, Taizhou, Zhejiang, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Local-regional recurrence free survival (LRFS)

    Time frame: 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 outcomes

  1. Overall survival (OS)

    Time frame: 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.

  2. Progression free survival (PFS)

    Time frame: 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.

  3. Distant metastasis-free survival (DMFS)

    Time frame: 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.

  4. Incidence of treatment related acute complications

    Time frame: up to 3 months

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

  5. Incidence of treatment related late complications

    Time frame: up to 5 years

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

  6. Overall response rate

    Time frame: up to 5 years

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

Other outcomes

  1. Biomarkers

    Time frame: up to 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Haihua Yang, MD

CONTACT

[email protected]

13819639006

Sponsors and collaborators

Lead sponsor

Taizhou Hospital

Other

Collaborators

  • Taizhou Cancer Hospital
  • Taizhou Enze Medical Center Group

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Mar 24, 2021
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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