Induction Chemotherapy Response-Guided Reduced-Dose Radiotherapy for Nasopharyngeal Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFudan University

About this trial

To evaluate whether the 2-year local failure-free survival (LRFFS) in Cohort 1 patients with AJCC/UICC 8th edition stage IB-II nasopharyngeal carcinoma who achieved EBV-DNA = 0 after induction chemotherapy and had MRI assessment of complete response (CR) or partial response (PR) ≥50% is non-inferior when treated with reduced-dose IMRT (59.4 Gy/27 fractions) compared to standard-dose IMRT (66.0 Gy/30 fractions).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 - 65 years old.

Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing cancer.

AJCC/UICC 9th edition stage IB-II untreated non-metastatic nasopharyngeal carcinoma (T3 requires no extensive cranial base invasion and the invasion volume should be < 22 mL; N1-2 requires baseline lymph nodes < 4 cm).

Before treatment, plasma EBV-DNA needs to be tested and dynamic monitoring of EBV-DNA can be completed.

Disqualifiers

Metastasis to T4, N3 or distant sites; AJCC/UICC 9th edition stage III-IV.

Had received chemotherapy, targeted therapy, or immunotherapy before the diagnosis of nasopharyngeal carcinoma, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).

Pregnant or lactating; non-pregnant and non-lactating subjects who do not agree to take effective contraceptive measures.

Had severe and uncontrollable heart, lung, liver, kidney, neurological or mental diseases, and the investigator judged that they were not suitable for radical treatment or affected compliance.

Trial design

Design model

Parallel

Treatments tested in this trial

  • reduced dose group

    Radiation

    59.4 Gy/27F

  • Standard Dose Group

    Radiation

    66 Gy/30F

  • concurrent chemoradiotherapy

    Other intervention

    66.0-70.4 Gy/30-32F + cisplatin 80 mg/m² q3w×2

Treatment groups

269 Participants
are divided into 3 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Group C: Corhort 2Other 1 intervention

Trial outcomes

Primary outcomes

1

2-year Locoregional Failure-Free Survival,2-y LRFFS

The time from enrollment to the first local or regional failure or any cause of death is determined by the event that occurs first. For those who did not experience any of these events, they are censored at the last valid follow-up date.

Time frame
2 year

Secondary outcomes

1

2-year Failure-Free Survival,2-y FFS

The time from enrollment to the first occurrence of local regional failure, distant metastasis, or death due to any cause is determined by the event that occurs first.

Time frame
2 year
2

2-year Overall Survival,2-y OS

The time from enrollment to any cause of death; for those who were still alive at the end of the follow-up, the data are censored at the date of the last confirmed survival.

Time frame
2 year
3

2-year Distant Failure-Free Survival,2-y DFFS

The time from enrollment to the first distant metastasis or any cause of death is determined by the event that occurs first.

Time frame
2 year
4

Acute Adverse Events,acute AEs

The evaluation was conducted according to NCI-CTCAE v5.0 from the start of radiotherapy to 90 days after radiotherapy.

Time frame
up to 90 days after radiotherapy

Other outcomes

Sponsors and contacts

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