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NCT Number: NCT05674305

Radiotherapy Alone Versus Concurrent Chemo-radiotherapy for Nasopharyngeal Carcincoma Patients With Undectable EBV DNA After One Cylce Neoadjuvant Chemotherpy

The goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA drop to undetectable level after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: the omission of concurrent chemotherapy is safe in the relatively good prognostic patients identified by the response of EBV DNA. Participants will be randomized to either radiotherapy alone or the standard treatment concurrent chemoradiotherapy if their EBV DNA decrease to undetectable level post first cycle of neoadjuvant chemotherapy and don't rebound in the second and third cycle.

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan Universtiy Shanghai Cancer Centre

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Hongmei Ying, M.D.

CONTACT

[email protected]

+8621-64175590 ext. 81400

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III.
  • Age 18-70 years.
  • Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer[AJCC] edition).
  • Patients with detectable pre-treatment plasma EBV DNA but undetectable EBV DNA after one cycle neoadjuvant and no EBV DNA rebound during the second and third cycle.
  • ECOG (Eastern Cooperative Oncology Group) score: 0-1
  • Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
  • Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 1.5 times the upper limit of normal value (ULN), total bilirubin <1.0×ULN.
  • Renal function: serum creatinine <1×ULN.
  • Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.

Exclusion criteria

  • Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
  • Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
  • Receiving radiotherapy or chemotherapy or targeted therapy previously
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
  • Severe, uncontrolled medical conditions and infections.
  • At the same time using other test drugs or in other clinical trials.
  • Refusal or inability to sign informed consent to participate in the trial.
  • Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct

Treatment and study plan

Radiotherapy

Drug

IMRT for primary and regional field

Cisplatin

Drug

Cisplatin 80mg/m2, 21days/cycle, 2 cycles

Primary outcomes

  1. Progression-free survival

    Time frame: 2 years

    Defined from date of randomization to date of first documentation of progression or death due to any cause

Secondary outcomes

  1. Overall survival

    Time frame: 2 years

    Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.

  2. Toxicities

    Time frame: 2 years

    Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.

  3. change of quality of life

    Time frame: 1 year

    QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy

Study contacts

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

Chengrun Du, MD and PhD

CONTACT

[email protected]

+86-15001733593

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Multicenter, Randomized, Non-inferior Phase III Study of Radiotherapy Alone Versus Concurrent Chemo-radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Complete Remission of EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jan 6, 2023
Registry last updated
Jan 10, 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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