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NCT Number: NCT06516133

Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma

In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.

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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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with a histological classification of non-keratinizing carcinoma (according to the World Health Organization, WHO), pathological classification.
  • No evidence of distant metastasis (M0).
  • Age between 18 and 70 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status score:0-1.
  • Undergoing radical intensity-modulated radiation therapy (IMRT).
  • No claustrophobia and able to remain in a fixed position for at least 30 minutes
  • Patients must be informed of the main content of this study, sign an informed consent form, and be willing and able to comply with the treatment, follow-up plan, laboratory tests, and other requirements specified in the study protocol.

Exclusion criteria

  • Histological types include squamous cell carcinoma or basal cell carcinoma.
  • Radiation therapy intended for palliative care.
  • History of malignant tumors, excluding adequately treated basal cell carcinoma, squamous cell carcinoma, and cervical intraepithelial neoplasia.
  • Pregnant or lactating women (women of childbearing age should undergo pregnancy testing; effective contraception should be emphasized during treatment.
  • Previous radical radiotherapy for nasopharyngeal cancer.
  • Primary and neck metastatic lesions treated with chemotherapy or surgery.
  • Presence of other serious underlying diseases that may pose a greater risk or affect compliance with the trial. Examples include unstable cardiac diseases requiring treatment, renal diseases, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5×ULN), and psychiatric disorders.
  • Initial assessment of treatment efficacy more than 120 days after the end of radiotherapy.
  • Inability to undergo enhanced magnetic resonance imaging due to contrast agent allergies, claustrophobia.

Treatment and study plan

Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy

Radiation

Radiation: Complete the full course of radiotherapy using the original treatment plan.

Planning target volume (PTV) margin: 3mm;

Chemotherapy

Drug

Chemotherapy: If given, platinum-based.

Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy

Radiation

Radiation: During the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of patients.

planning target volume (PTV) margin: smaller.

Primary outcomes

  1. Locoregional recurrence-free survival

    Time frame: 3-year

    locoregional progression free survival

Secondary outcomes

  1. Overall survival

    Time frame: 3-year

    overall survival

  2. Distant metastasis free survival

    Time frame: 3-year

    Distant metastasis free survival

  3. Rate of acute radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0)

    Time frame: 3 months

    Acute radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.

  4. Rate of late radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0).

    Time frame: 3-year

    Late radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.

  5. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 Version 1.0 (EORTC QLQ-HN35 V1.0)

    Time frame: From baseline to 3 years post-radiotherapy

    The minimum and maximum values are 0 and 4 respectively. The higher scores mean a worse outcome.

  6. and National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Version 1.0 (NCI-PRO-CTCAE V1.0.)

    Time frame: From baseline to 3 years post-radiotherapy

    The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.

Study contacts

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

Guan-qun Zhou, PhD

CONTACT

[email protected]

+86 159 1437 2887

Yu-xian Yang, MD

CONTACT

[email protected]

+86 147 4892 2370

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Artificial Intelligence Empowered Online Adaptive Radiotherapy Versus Conventional Radiotherapy in Non-metastatic Nasopharyngeal Carcinoma: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial

Acronym: OART

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

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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