Nasopharyngeal Cancer RecurrentNCT02113423
Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma
A study testing 3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT in people with Nasopharyngeal Cancer Recurrent, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
The hypothesis of the study is to address the efficacy and toxicity profile of aforementioned four modalities for rT1-2 NPC. Characters of the patients: list item one: 168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC were diagnosed list item two: Treated with four different irradiation… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Nasopharyngeal Cancer Recurrent
- What is being tested?
- 3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- Jan 1996to Mar 2011
- Phase
- Interventional
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- recurrent T1-2 nasopharyngeal carcinoma patients
Who cannot join
- non recurrent T1-2 nasopharyngeal carcinoma patients
Trial locations and contacts
1 site in 1 country.
China1 site
Fujian Cancer Hospital Radiation Oncology Department
Fuzhou, Fujian, 350014
About this study
Official title: Superiority of Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma
The hypothesis of the study is to address the efficacy and toxicity profile of aforementioned four modalities for rT1-2 NPC.
Characters of the patients:
- list item one: 168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC were diagnosed
- list item two: Treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT Combined 3D-CRT or IMRT).
- list item three: Median time to recurrence was 30 months (range 1-180months). The median follow-up time was 28 months (range, 4-135 months).
Read the detailed description
Objectives:
Recurrent T1-2 Nasopharyngeal Carcinoma (rT1-2) may be salvaged by 3D - CRT（3D-Conformal Radiotherapy）, IMRT（ Intensity Modulated Radiotherapy）, Brachytherapy (BT), BT combined 3D - CRT or IMRT . The aim of this study is to address the efficacy and toxicity profile of aforementioned four modalities for rT1-2 NPC.
Methods and Materials:
168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC were diagnosed and treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT Combined 3D-CRT or IMRT) . Median time to recurrence was 30 months (range 1-180months). The median follow-up time was 28 months (range, 4-135 months).
- Conditions
- Nasopharyngeal Cancer Recurrent
- Being tested
- 3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT
- Keywords
- superiority, re-irradiation, IMRT, recurrent T1-2 NPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRTRadiation
3D - CRT（3D-Conformal Radiotherapy）: CTV-P 50-60Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week) IMRT（Intensity Modulated Radiotherapy）: GTV-P 50-60 Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week) BT(Brachytherapy): 2.5Gy BID*10F one week interval BT combined 3D - CRT or IMRT: First,GTV-P 40Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week);Then, 2.5Gy BID*2F
| Study group | Role | What they receive |
|---|---|---|
| recurrent T1-2 NPC,no treatment | Experimental | 3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT Receives: Radiation: 3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: thirteen years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJan 1996
- Primary completionJun 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jianji Pan, MD, Study director, Department of Radiation Oncology, Cancer Hospital of Fujian Medical University, Fuzhou, Fujian, People's Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113423
- Sponsor's protocol ID
- FJCH009911
- Status last verified
- Apr 2014
- First submitted
- 8 Apr 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superiority of Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02113423
- Acronym / sponsor ID
- FJCH009911
- Conditions
- Nasopharyngeal Cancer Recurrent
- Keywords
- superiority, re-irradiation, IMRT, recurrent T1-2 NPC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- Jan 1996
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Apr 2014 (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.
The hypothesis of the study is to address the efficacy and toxicity profile of aforementioned four modalities for rT1-2 NPC.
Characters of the patients:
- list item one: 168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC were diagnosed
- list item two: Treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT Combined 3D-CRT or IMRT).
- list item three: Median time to recurrence was 30 months (range 1-180months). The median follow-up time was 28 months (range, 4-135 months).
Detailed description
Objectives:
Recurrent T1-2 Nasopharyngeal Carcinoma (rT1-2) may be salvaged by 3D - CRT（3D-Conformal Radiotherapy）, IMRT（ Intensity Modulated Radiotherapy）, Brachytherapy (BT), BT combined 3D - CRT or IMRT . The aim of this study is to address the efficacy and toxicity profile of aforementioned four modalities for rT1-2 NPC.
Methods and Materials:
168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC were diagnosed and treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT Combined 3D-CRT or IMRT) . Median time to recurrence was 30 months (range 1-180months). The median follow-up time was 28 months (range, 4-135 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| recurrent T1-2 NPC,no treatment | Experimental | Radiation: 3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- recurrent T1-2 nasopharyngeal carcinoma patients
Key exclusion criteria (1 listed)
- non recurrent T1-2 nasopharyngeal carcinoma patients
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 |
|---|---|---|
| 3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT3D - CRT（3D-Conformal Radiotherapy）: CTV-P 50-60Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week) IMRT（Intensity Modulated Radiotherapy）: GTV-P 50-60 Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week) BT(Brachytherapy): 2.5Gy BID*10F one week interval BT combined 3D - CRT or IMRT: First,GTV-P 40Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week);Then, 2.5Gy BID*2F | Radiation | recurrent T1-2 NPC,no treatment |
Primary outcome
all cause mortality
Time frame: thirteen years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
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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.
Jianji Pan, MD study director
Department of Radiation Oncology, Cancer Hospital of Fujian Medical University, Fuzhou, Fujian, People's Republic of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT in people with Nasopharyngeal Cancer Recurrent, run by Fujian Cancer Hospital at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: thirteen years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2014.