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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photon combined with Carbon ion | Experimental | The participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors. |
|
| Proton combined with Carbon ion | Experimental | The participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photon | Radiation | Photon combined with Carbon ion in Arm 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03 | 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. | Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival of all patients | From randomization to death, a median of 3 years. | |
| Progression-free survival of all patients | From randomization to death or disease progression, a median of 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiade Lu, MD | Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion Center | Shanghai | Shanghai Municipality | 201315 | China |
Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.
Within 5 years after the publication of the study
Data may be shared with radiation oncologists who are interested in examining the efficacy and toxicity of nasopharyngeal carcinoma patients treated with particle beam radiotherapy. Pooled analysis comparing IMRT and particle beam radiotherapy will be of particular interest. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017785 | Photons |
| D011522 | Protons |
| ID | Term |
|---|---|
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
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| Proton |
| Radiation |
Proton combined with Carbon ion in Arm 2 |
|
| Carbon ion | Radiation | Same dose and fractionation will be used in both arms. |
|
| Local control | From randomization to local failure, a median of 3 years. |
| Regional control | From randomization to regional failure, 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 | Acute and late toxicities induced by radiation therapy other than xerostomia. | Time interval from start to 3 months after completion of radiotherapy. |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D055590 |
| Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |