Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma

NCT ID: NCT06516133

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-17

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional radiotherapy with conventional margins w or w/o chemotherapy

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type RADIATION

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

Planning target volume (PTV) margin: 3mm;

Chemotherapy

Intervention Type DRUG

Chemotherapy: If given, platinum-based.

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

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Chemotherapy

Intervention Type DRUG

Chemotherapy: If given, platinum-based

Interventions

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

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

Planning target volume (PTV) margin: 3mm;

Intervention Type RADIATION

Chemotherapy

Chemotherapy: If given, platinum-based.

Intervention Type DRUG

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

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.

Intervention Type RADIATION

Chemotherapy

Chemotherapy: If given, platinum-based

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with a histological classification of non-keratinizing carcinoma (according to the World Health Organization, WHO), pathological classification.
2. No evidence of distant metastasis (M0).
3. Age between 18 and 70 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status score:0-1.
5. Undergoing radical intensity-modulated radiation therapy (IMRT).
6. No claustrophobia and able to remain in a fixed position for at least 30 minutes
7. 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

1. Histological types include squamous cell carcinoma or basal cell carcinoma.
2. Radiation therapy intended for palliative care.
3. History of malignant tumors, excluding adequately treated basal cell carcinoma, squamous cell carcinoma, and cervical intraepithelial neoplasia.
4. Pregnant or lactating women (women of childbearing age should undergo pregnancy testing; effective contraception should be emphasized during treatment.
5. Previous radical radiotherapy for nasopharyngeal cancer.
6. Primary and neck metastatic lesions treated with chemotherapy or surgery.
7. 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.
8. Initial assessment of treatment efficacy more than 120 days after the end of radiotherapy.
9. Inability to undergo enhanced magnetic resonance imaging due to contrast agent allergies, claustrophobia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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YingSun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu-xian Yang, MD

Role: CONTACT

+86 147 4892 2370

Guan-qun Zhou, PhD

Role: CONTACT

+86 159 1437 2887

Facility Contacts

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Yu-xian Yang

Role: primary

+86 147 4892 2370

Guan-quan Zhou

Role: backup

+86 159 1437 2887

Other Identifiers

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SL-B2023-685-02

Identifier Type: -

Identifier Source: org_study_id

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