Nasopharyngeal NeoplasmsPhase 2NCT01762514
A Phase II Clinical Trial on Comparison of Effectiveness and Safeness of Different Amifostine Regimens
A Phase 2 study testing Amifostine every-other-day regimen and Amifostine everyday regimen in people with Nasopharyngeal Neoplasms and Salivary Gland Diseases, run by Sun Yat-sen University at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Neoplasms, Salivary Gland Diseases, Bone Marrow Diseases
- What is being tested?
- Amifostine every-other-day regimen and Amifostine everyday regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 7 sitesChina
- Study dates
- Jan 2013to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 2 recruiting
- Suspended
The Main Guangzhou Hospital of the Guangzhou Military Region
Guangzhou, Guangdong, 510010
- Recruiting
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Yun-fei Xia, Prof., +86-13602805461, xiayf@hpotmail.com
Hui Chang, M.D., +86-13480295989, changhui@sysucc.org.cn
- Suspended
The Affiliated Cancer Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, 510095
- Suspended
Guangdong Provincial Hospital Of Chinese Medicine
Guangzhou, Guangdong, 510120
- Recruiting
The First Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, 510120
Dao-li Niu, Prof., +86-13711101855, daoliniu@163.com
Dao-li Niu, Prof.
- Suspended
The Second Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510260
- Withdrawn
Guangdong Second People's Hospital
Guangzhou, Guangdong, 510317
About this study
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
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.
Read the 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.
- Being tested
- Amifostine every-other-day regimen, Amifostine everyday regimen
- Keywords
- Nasopharyngeal carcinoma, Amifostine, Myelosuppression, Xerostomia, Mucositis
- Medical subject headings
- Nasopharyngeal Neoplasms, Salivary Gland Diseases, Bone Marrow Diseases, Mucositis, Nasopharyngeal Carcinoma, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amifostine every-other-day regimenDrug
Also called Amifostine administered 3 times per week regimen
Amifostine 400mg/d, every-other-day regimen from Monday to Friday, every week repetition during radiotherapy
Amifostine everyday regimenDrug
Also called Amifostine administered 5 times per week regimen
Amifostine 400mg/d, everyday regimen from Monday to Friday, every week repetition during radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Amifostine every-other-day regimen |
| Program III | Active comparator | Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine everyday regimen Receives: Drug: 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 Receives: Drug: Amifostine every-other-day regimen |
| Program VI | Active comparator | Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine everyday regimen Receives: Drug: Amifostine everyday regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on improving myelosuppression
Severity of myelosuppression is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
Measured: 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.
Measured: 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.
Measured: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Secondary outcomes (6)
Effect on improving Quality of Life (QOL).
Measured: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Effect on improving Karnofsky Performance Scores (KPS)
Measured: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Incidence and severity of Nausea
One of the adverse effects of Amifostine.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Dalian Merro Pharmaceutical Co. Ltd
- Responsible party
- Principal investigator, Yun-fei Xia, Sun Yat-sen University
- Investigators
- Yun-fei Xia, Prof., Principal investigator, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762514
- Sponsor's protocol ID
- AMF-BYA-02
- Status last verified
- Jul 2017
- First submitted
- 22 Dec 2012
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31448214Chang 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.
PubMed 30046225
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01762514
- Acronym / sponsor ID
- AMF-BYA-02
- Keywords
- Nasopharyngeal carcinoma, Amifostine, Myelosuppression, Xerostomia, Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Dalian Merro Pharmaceutical Co. Ltd
- Study start
- Jan 2013
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Amifostine every-other-day regimenPatients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine every-other-day regimen |
| Program III | Active comparator | Drug: Amifostine everyday regimenPatients 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 | Drug: Amifostine every-other-day regimenPatients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine every-other-day regimen |
| Program VI | Active comparator | Drug: Amifostine everyday regimenPatients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine everyday regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amifostine every-other-day regimenAlso: Amifostine administered 3 times per week regimenAmifostine 400mg/d, every-other-day regimen from Monday to Friday, every week repetition during radiotherapy | Drug | Program II, Program V |
| Amifostine everyday regimenAlso: Amifostine administered 5 times per week regimenAmifostine 400mg/d, everyday regimen from Monday to Friday, every week repetition during radiotherapy | Drug | Program III, Program VI |
Primary outcome
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.
6 secondary outcomes
Effect on improving Quality of Life (QOL).
Time frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Effect on improving Karnofsky Performance Scores (KPS)
Time frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Incidence and severity of Nausea
Time frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Incidence and severity of Vomiting
Time frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Incidence and severity of Hypotension
Time frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Incidence and severity of Hypocalcemia
Time frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Derived from this study: PubMed 31448214Liu 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.
- Derived from this study: PubMed 30046225Chang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-fei Xia, Prof. principal investigator
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amifostine every-other-day regimen and Amifostine everyday regimen in people with Nasopharyngeal Neoplasms and Salivary Gland Diseases, run by Sun Yat-sen University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun-fei Xia, Prof. (+86-13602805461, xiayf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on improving myelosuppression (time frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01762514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.