Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma

NCT06516133 | Recruiting Phase 3 DMC

• 1 other identifier: SL-B2023-685-02
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; Online adaptive radiotherapy; Smaller PTV margin

Outcome Measures

Primary Outcomes (1)

• Locoregional recurrence-free survival

  locoregional progression free survival

  3-year

Secondary Outcomes (6)

• Overall survival

  3-year

• Distant metastasis free survival

  3-year

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

  3 months

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

  3-year

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

  From baseline to 3 years post-radiotherapy

Study Arms (2)

Conventional radiotherapy with conventional margins w or w/o chemotherapy

ACTIVE COMPARATOR

Complete the full course of radiotherapy using the original treatment plan. PTV margin: 3mm.

Radiation: Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy; Drug: Chemotherapy

Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy

EXPERIMENTAL

Throughout 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 the patients. PTV margin: smaller.

Radiation: Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy; Drug: Chemotherapy

Interventions

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;

Conventional radiotherapy with conventional margins w or w/o chemotherapy

Chemotherapy DRUG

Chemotherapy: If given, platinum-based.

Conventional radiotherapy with conventional margins w or w/o chemotherapy

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.

Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Yu-xian Yang, MD

CONTACT

+86 147 4892 2370; yangyx1@sysucc.org.cn

Guan-qun Zhou, PhD

CONTACT

+86 159 1437 2887; zhougq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: July 23, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)