Clinical trial NCT01762514: A Phase II Clinical Trial on Comparison of Effectiveness and Safeness of Different Amifostine Regimens
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Neoplasms
Salivary Gland Diseases
Bone Marrow Diseases
Mucositis
Keywords: Nasopharyngeal carcinoma
Amifostine
Myelosuppression
Xerostomia
Mucositis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Dalian Merro Pharmaceutical Co. Ltd
First posted: 2013-01-07
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect on improving myelosuppression
timeFrame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
measure: Effect on improving xerostomia
timeFrame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
measure: Effect on improving mucositis
timeFrame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Secondary outcomes:
measure: Effect on improving Quality of Life (QOL).
timeFrame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
measure: Effect on improving Karnofsky Performance Scores (KPS)
timeFrame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
measure: Incidence and severity of Nausea
timeFrame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
measure: Incidence and severity of Vomiting
timeFrame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
measure: Incidence and severity of Hypotension
timeFrame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
measure: Incidence and severity of Hypocalcemia
timeFrame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Main Guangzhou Hospital of the Guangzhou Military Region
state: Guangdong
city: Guangzhou
country: China
facility: Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The Affiliated Cancer Hospital Of Guangzhou Medical Collage
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital Of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical Collage
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Second People's Hospital
state: Guangdong
Study officials:
affiliation: Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
name: Yun-fei Xia, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.