Nasopharyngeal Carcinoma (NPC)
Conditions
Keywords
Nasopharyngeal Carcinoma, EBV DNA, MRI, reduced dose radiotherapy, induction chemotherapy
Brief summary
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).
Detailed description
This study focused on patients with AJCC/UICC 9th edition stage IB-II（The participants were required to have no extensive skull base invasion and lymph nodes \< 4 cm before treatment）. It aimed to adaptively guide the reduction of radiation dose for nasopharyngeal carcinoma based on the response to induction chemotherapy, thereby minimizing radiation-related toxicity while ensuring local control. Cohort 1 was randomly assigned 1:1 to the 59.4 Gy/27 fractions group and the 66.0 Gy/30 fractions group and compared their LRFFS. The participants were required to have EBV-DNA = 0 and CR or PR \> 50% after 2 courses of induction therapy. Those who did not meet the criteria were assigned to Cohort 2 to receive standard-dose radiotherapy combined with concurrent cisplatin to avoid excessive reduction of intensity for potentially high-risk patients.
Interventions
RADIATIONreduced dose group
59.4 Gy/27F
RADIATIONStandard Dose Group
66 Gy/30F
OTHERconcurrent chemoradiotherapy
66.0-70.4 Gy/30-32F + cisplatin 80 mg/m² q3w×2
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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. * ECOG performance status 0 - 1 points. * Main organ functions meet the following requirements: neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN; creatinine clearance rate ≥ 60 mL/min. * Sign a written informed consent form and be willing to complete the treatment, follow-up and quality of life assessment according to the protocol.
Exclusion criteria
* 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. * Had a history of other malignant tumors within the past 5 years, except for the following situations: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc. * Could not complete the imaging examinations, EBV-DNA tests, follow-up or quality of life assessment as required by the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Locoregional Failure-Free Survival，2-y LRFFS | 2 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Failure-Free Survival，2-y FFS | 2 year | 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. |
| 2-year Overall Survival，2-y OS | 2 year | 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. |
| 2-year Distant Failure-Free Survival，2-y DFFS | 2 year | The time from enrollment to the first distant metastasis or any cause of death is determined by the event that occurs first. |
| Acute Adverse Events，acute AEs | up to 90 days after radiotherapy | The evaluation was conducted according to NCI-CTCAE v5.0 from the start of radiotherapy to 90 days after radiotherapy. |
| Late Adverse Events，late AEs | After 90 days of radiotherapy to the date of death，assessed up to 2 years or more. | After 90 days of radiotherapy, the evaluation was conducted according to CTCAE v5.0 and RTOG/EORTC standards for late radiation injury. |
| Quality of Life，QoL (EORTC QLQ-H&N35） | baseline and up to one year | Changes in QoL of participants from baseline to up to 6 months after the completion of radiotherapy. QoL will be evaluated with the questionnaires of the head-and-neck-specific module (H\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30). Higher scores mean a worse outcome. |
Countries
China
Contacts
CONTACTXiayun He, MD
CONTACTFen Xue, MD
PRINCIPAL_INVESTIGATORXiayun He
Fudan University
Outcome results
None listed