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| Name | Class |
|---|---|
| Dalian Merro Pharmaceutical Co. Ltd | UNKNOWN |
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RATIONALE
PURPOSE
RATIONALE: Nasopharyngeal carcinoma is a kind of malignant tumor which is treated primarily by radiation therapy. This therapeutic strategy often causes adverse effects such as dysfunction of salivary gland and lesion of oral mucosa. With concurrent chemotherapy, it may also cause toxicity to kidney, bone marrow, and other organs or tissues. When administered prior to chemoradiotherapy, Amifostine has been proved to has the ability of protecting the normal from these adverse effects so as to improve the patient tolerance. However, there are also some side effects of Amifostine itself, such as nausea, vomiting and hypotension, especially when high dose is applied.
PURPOSE: This phase II randomized controlled trial is to study the protecting effect and its safety of Amifostine every-other-day regimen compared with standard everyday regimen on adverse effects such as myelosuppression, xerostomia and mucositis, in patients with nasopharyngeal carcinoma Stage T1-T4, N0-N3, M0 and undergoing concurrent chemoradiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program I | No Intervention | Patients with American Joint Cancer Committee/Union Internationale Contre le Cancer (UICC/AJCC) 2010 Stage I and II; Radiotherapy applied | |
| Program II | Experimental | Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine every-other-day regimen |
|
| Program III | Active Comparator | Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine everyday regimen |
|
| Program IV | No Intervention | Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied | |
| Program V | Experimental | Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine every-other-day regimen |
|
| Program VI | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amifostine every-other-day regimen | Drug | Amifostine 400mg/d, every-other-day regimen from Monday to Friday, every week repetition during radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect on improving myelosuppression | Severity of myelosuppression is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy |
| Effect on improving xerostomia | Severity of xerostomia is evaluated on basis of CTCAE 4.0 criteria. | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy |
| Effect on improving mucositis | Severity of mucositis is evaluated on basis of CTCAE 4.0 criteria. | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on improving Quality of Life (QOL). | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy | |
| Effect on improving Karnofsky Performance Scores (KPS) | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun-fei Xia, Prof. | Contact | +86-13602805461 | xiayf@hotmail.com | |
| Hui Chang, M.D. | Contact | +86-13480295989 | changhui@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yun-fei Xia, Prof. | Department of Radiation Oncology, Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Main Guangzhou Hospital of the Guangzhou Military Region | Suspended | Guangzhou | Guangdong | 510010 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31448214 | Derived | Liu Y, Shi H, Huang S, Chen X, Zhou H, Chang H, Xia Y, Wang G, Yang X. Early prediction of acute xerostomia during radiation therapy for nasopharyngeal cancer based on delta radiomics from CT images. Quant Imaging Med Surg. 2019 Jul;9(7):1288-1302. doi: 10.21037/qims.2019.07.08. | |
| 30046225 | Derived | Chang H, Yi W, Wang X, Tao Y, Yang X, Chen C, Zhang W, Zhou S, Liu S, Li X, Ding S, Li J, Li G, Shao X, Liu Y, Song W, Xia Y. Effectiveness and safety of different amifostine regimens: Preliminary results of a phase II multicenter randomized controlled trial. Chin J Cancer Res. 2018 Jun;30(3):307-314. doi: 10.21147/j.issn.1000-9604.2018.03.03. |
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Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine everyday regimen
|
|
| Amifostine everyday regimen | Drug | Amifostine 400mg/d, everyday regimen from Monday to Friday, every week repetition during radiotherapy |
|
|
| Incidence and severity of Nausea | One of the adverse effects of Amifostine. | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy |
| Incidence and severity of Vomiting | One of the adverse effects of Amifostine. | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy |
| Incidence and severity of Hypotension | One of the adverse effects of Amifostine. | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy |
| Incidence and severity of Hypocalcemia | One of the adverse effects of Amifostine. | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy |
| Department of Radiation Oncology, Sun Yat-Sen University Cancer Center |
| Recruiting |
| Guangzhou |
| Guangdong |
| 510060 |
| China |
|
| The Affiliated Cancer Hospital Of Guangzhou Medical Collage | Suspended | Guangzhou | Guangdong | 510095 | China |
| Guangdong Provincial Hospital Of Chinese Medicine | Suspended | Guangzhou | Guangdong | 510120 | China |
| The First Affiliated Hospital Of Guangzhou Medical Collage | Recruiting | Guangzhou | Guangdong | 510120 | China |
|
| The Second Affiliated Hospital, Sun Yat-Sen University | Suspended | Guangzhou | Guangdong | 510260 | China |
| Guangdong Second People's Hospital | Withdrawn | Guangzhou | Guangdong | 510317 | China |
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| D012466 | Salivary Gland Diseases |
| D001855 | Bone Marrow Diseases |
| D052016 | Mucositis |
| D000077274 | Nasopharyngeal Carcinoma |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009059 | Mouth Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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