Clinical trial · Interventional
A Phase II Clinical Trial on Comparison of Effectiveness and Safeness of Different Amifostine Regimens
A Multi-institutional, Randomized Parallel Controlled, Phase II Clinical Trial on Comparison of Effectiveness and Safeness of Amifostine Every-other-day Regimen and Everyday Regimen From Monday to Friday
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE * Radiotherapy is the primary therapeutic strategy for nasopharyngeal carcinoma. * Radiotherapy may cause adverse effect such as xerostomia and mucositis. * Amifostine has the ability of protecting the normal tissue but also has some side effects. PURPOSE * This phase II trial is to study the protecting effect and safety of different Amifostine regimens in patients with nasopharyngeal carcinoma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Diseases | — | UNRESOLVED | — |
| Mucositis | — | UNRESOLVED | — |
| Nasopharyngeal Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Salivary Gland Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifostine everyday regimen | Drug | — | UNRESOLVED |
| Amifostine every-other-day regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- NO_INTERVENTION
- label
- Program I
- description
- Patients with American Joint Cancer Committee/Union Internationale Contre le Cancer (UICC/AJCC) 2010 Stage I and II; Radiotherapy applied
- type
- EXPERIMENTAL
- label
- Program II
- description
- Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine every-other-day regimen
- interventionNames
- Drug: Amifostine every-other-day regimen
- type
- ACTIVE_COMPARATOR
- label
- Program III
- description
- Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine everyday regimen
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Nasopharyngeal cancer patients diagnosed by pathology or cytology * UICC/AJCC 2010 Stage T1-4 N0-3 M0 * Male or female patients with age between 18 and 75 years old * Karnofsky Performance Scores ≥ 60 * Expected survival ≥ 3 months * Without dysfunction of heart, lung, liver, kidney and hematopoiesis * No previous allergic reaction to the drug Exclusion Criteria: * History of alcohol or drug abuse within 3 months * Pregnant or lactating women * Currently under treatment with other similar drugs * Anti-hypertension drugs applied in less than 24 hours * Severe hypocalcemia * Dysfunction of heart, lung, liver, kidney or hematopoiesis * Severe neurological, mental or endocrine diseases * Previous allergic reaction to the drug * Patients participated in clinical trials of other drugs within last 3 months * Other unsuitable reason
References
Publications (2)
- DERIVEDLiu 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. PMID 31448214
- DERIVEDChang 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. PMID 30046225