Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal carcinoma, Intensity-modulated radiation therapy, Proton beam therapy, Carbon-ion radiotherapy, Toxicity, Survival, Disease control
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.
Interventions
RADIATIONPhoton
Photon combined with Carbon ion in Arm 1
RADIATIONProton
Proton combined with Carbon ion in Arm 2
RADIATIONCarbon ion
Same dose and fractionation will be used in both arms.
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03 | Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy | CTCAE refers to Common Terminology Criteria for Adverse Events, which is one of the most frequently used criteria for toxicity grading after anti-cancer treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival of all patients | From randomization to death or disease progression, a median of 3 years. | — |
| Local control | From randomization to local failure, a median of 3 years. | — |
| Overall survival of all patients | From randomization to death, a median of 3 years. | — |
| Distant control | From randomization to distant failure, a median of 3 year. | — |
| Treatment-related adverse events as assessed by NCI CTCAE v4.03 | Time interval from start to 3 months after completion of radiotherapy. | Acute and late toxicities induced by radiation therapy other than xerostomia. |
| Regional control | From randomization to regional failure, a median of 3 years. | — |
Countries
China
Contacts
Primary ContactLin Kong, MD
Backup ContactJiyi Hu, MD
Outcome results
None listed