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40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma

ConditionNasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMing-Yuan Chen

About this trial

This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients are informed of the basic content of this study and sign an informed consent form;

Age between 18 and 75 years;

Pathologically diagnosed as non-keratinising nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III);

Staged according to the 9th edition of the AJCC/UICC TNM classification as T1-3N2M0 or T3N0-1M0 (Stage II);

Disqualifiers

Patients with recurrent/metastatic nasopharyngeal carcinoma;

Pregnant or breastfeeding women (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasised during treatment);

Patients with a history of malignant tumours, excluding those who have undergone curative treatment for cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, or ductal carcinoma in situ;

Patients whose local/regional lesions have undergone radiotherapy or surgery (excluding diagnostic surgery), or whose lesions exhibit significant necrosis, making radiotherapy unsuitable or potentially leading to radiotherapy resistance;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cisplatin-based induction chemotherapy

    Drug

    Gemcitabine + cisplatin: Gemcitabine, 1,000 mg/m², Q3W, d1+d8, IV drip; cisplatin, 80 mg/m², Q3W, d1-3, IV drip. A total of 3 cycles. (Note: Gemcitabine can be replaced by docetaxel, albumin-bound paclitaxel, paclitaxel, etc.)

  • Full course of PD-1 monoclonal antibody

    Drug

    Tislelizumab 200 mg , once every 3 weeks (Q3W), intravenous infusion (iv). A total of 12 courses of treatment will be administered, including 3 courses during the induction chemotherapy phase, 3 courses during the radiotherapy phase, and 6 courses during the post-radiotherapy maintenance phase. Administration will start on Day 1 of induction chemotherapy and continue after the end of radiotherapy until the occurrence of intolerable toxicities, disease progression, withdrawal of consent, determination by the investigator that the patient needs to withdraw from treatment, or the completion of 12 courses, whichever comes first.

  • Reduced-dose radiotherapy to CTV2

    Radiation

    GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 40.2Gy/30F/1.34Gy

  • Conventional-dose radiotherapy to CTV2

    Radiation

    GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 49.2Gy/30Fr/1.64Gy

Treatment groups

346 Participants
are divided into 2 treatment groups
Group A: Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapyExperimental treatment 3 interventions
Group B: Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapyActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progress-Free Survival (PFS)

Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

Time frame
3 years
2

Incidence of ≥3 grade adverse events

According to NCI-CTCAE 5.0, the proportion of patients who experienced ≥3 grade adverse events during treatment and follow-up.

Time frame
3 years

Secondary outcomes

1

Distant Metastasis-Free Survival (DMFS)

Defined as the time interval from randomization to the date of first distant metastases.

Time frame
3 years
2

Locoregional Relapse-Free Survival (LRRFS)

Defined as the time from randomisation to the date of first locoregional relapse.

Time frame
3 years
3

Overall Survival (OS)

Defined as the time interval from randomization to death due to any cause.

Time frame
3 years
4

Objective Response Rate (ORR)

Defined as the proportion of patients with tumor reduction achieving complete response (CR) or partial response (PR), assessed at 3 months after the end of concurrent chemoradiotherapy.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ming-Yuan Chen

Lead sponsor

Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov
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