Clinical trial NCT04528394: Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma
Official title: A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
Intensity-modulated radiation therapy
Proton beam therapy
Carbon-ion radiotherapy
Toxicity
Survival
Disease control
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.

Detailed description: The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent \[GyE\]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type).
* Age ≥ 18 and ≤ 70 years of age.
* Eastern Cooperative Oncology Group score: 0-1.
* Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil \> 2000/mm\^3; 2) platelet \> 100,000/mm\^3; 3) total bilirubin \< 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase \< 1.5 upper limit of normal; 5) SCr \< 1.5mg/dl; creatinine clearance rate \> 60ml/min.
* Willing to accept adequate contraception for women with childbearing potential.
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.

Exclusion Criteria:

* Presence of distant metastasis.
* Received radiotherapy for head and neck before.
* Received surgery(except for biopsy) for primary lesion or cervical lymph node.
* Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
* Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of xerostomia.
* Accompanied with severe major organ dysfunction.
* Presence of mental disease that may influence the understanding of informed consent.

Primary outcomes:
measure: Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03
timeFrame: Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy
Secondary outcomes:
measure: Overall survival of all patients
timeFrame: From randomization to death, a median of 3 years.
measure: Progression-free survival of all patients
timeFrame: From randomization to death or disease progression, a median of 3 years.
measure: Local control
timeFrame: From randomization to local failure, a median of 3 years.
measure: Regional control
timeFrame: From randomization to regional failure, a median of 3 years.
measure: Distant control
timeFrame: From randomization to distant failure, a median of 3 year.
measure: Treatment-related adverse events as assessed by NCI CTCAE v4.03
timeFrame: Time interval from start to 3 months after completion of radiotherapy.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
name: Jiade Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: