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
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 360
- Locations
- 7
- Primary Endpoint
- Effect on improving myelosuppression
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Program II
Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine every-other-day regimen
Intervention: Amifostine every-other-day regimen (Drug)
Program III
Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine everyday regimen
Intervention: Amifostine everyday regimen (Drug)
Program V
Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine every-other-day regimen
Intervention: Amifostine every-other-day regimen (Drug)
Program VI
Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine everyday regimen
Intervention: Amifostine everyday regimen (Drug)
Outcomes
Primary Outcomes
Effect on improving myelosuppression
Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Severity of myelosuppression is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
Effect on improving xerostomia
Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Severity of xerostomia is evaluated on basis of CTCAE 4.0 criteria.
Effect on improving mucositis
Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Severity of mucositis is evaluated on basis of CTCAE 4.0 criteria.
Secondary Outcomes
- 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)
- Incidence and severity of Nausea(One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy)
- Incidence and severity of Vomiting(One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy)
- Incidence and severity of Hypotension(One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy)
- Incidence and severity of Hypocalcemia(One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy)
Investigators
Yun-fei Xia
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Sun Yat-sen University