Nasopharyngeal CarcinomaPhase 2/3NCT00778908
Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma
A Phase 2/3 study testing Late-course accelerated hyperfractionated IMRT, Concomitant cisplatin chemotherapy and Conventionally fractionated IMRT in people with Nasopharyngeal Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial summary
Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Late-course accelerated hyperfractionated IMRT, Concomitant cisplatin chemotherapy and Conventionally fractionated IMRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2011
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven non-keratinizing or undifferentiated type nasopharyngeal carcinoma for primary treatment with curative intent
- According to AJCC 2002 Staging System, clinical stage must be Ⅱb-Ⅳb
- Age between 18-70
- Karnofsky performance status ≥70
- WBC ≥4,000/mm3, PLT ≥ 100,000/mm3,serum creatinine ≤ 1.6 mg/dl
- Without radiotherapy or chemotherapy
- Signed study-specific consent form prior to study entry
Who cannot join
- Patients with distant metastasis
- Pregnant or lactating women
- The presence of uncontrolled life-threatening illness
- Patients who received radiotherapy or chemotherapy previously
Trial locations and contacts
1 site in 1 country.
China1 site
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
About this study
Official title: Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial
Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of IMRT might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The study is designed to test if late-course accelerated hyperfractionated IMRT can improve the outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Late-course accelerated hyperfractionated IMRT, Concomitant cisplatin chemotherapy, Conventionally fractionated IMRT
- Keywords
- Nasopharyngeal carcinoma, Locally advanced disease, Intensity-modulated radiation therapy, Accelerated hyperfractionation, Concomitant boost radiation therapy, Concurrent chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Late-course accelerated hyperfractionated IMRTRadiation
- IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease
- IMRT delivery scheduling: (1) Six-week treatment: PTV1=60Gy/30fractions, PTV2=57Gy/30fractions,PTV3=54Gy/30fractions.(2) Concomitant boost to PTV1 as a second daily treatment for the last 10 treatments of the Six-week treatment: PTV1=12Gy/10fractions.(3) PTV3 will be treated with conventional radiotherapy technique separately.
Concomitant cisplatin chemotherapyDrug
cisplatin:40mg/m2 weekly infusion for 6 weeks
Conventionally fractionated IMRTRadiation
IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Seven-week treatment: PTV1=70Gy/35fractions, PTV2=63Gy/35fractions,PTV3=55.8Gy/31fractions.(2) PTV3 will be treated with conventional radiotherapy technique separately.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy Receives: Radiation: Late-course accelerated hyperfractionated IMRT; Drug: Concomitant cisplatin chemotherapy |
| B | Other | Conventionally fractionated IMRT with concomitant cisplatin chemotherapy Receives: Drug: Concomitant cisplatin chemotherapy; Radiation: Conventionally fractionated IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local/regional control rate, Acute and late toxicities
Measured: 2-Yr
Secondary outcomes (1)
Overall survival rate
Measured: 5-Yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi Sci-Tech Office
- Responsible party
- Principal investigator, Heming Lu, People's Hospital of Guangxi Zhuang Autonomous Region
- Investigators
- Heming Lu, MD, Study chair, Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778908
- Sponsor's protocol ID
- GUIKEGONG-0816004-40
- Status last verified
- Aug 2012
- First submitted
- 22 Oct 2008
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00778908
- Acronym / sponsor ID
- GUIKEGONG-0816004-40
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal carcinoma, Locally advanced disease, Intensity-modulated radiation therapy, Accelerated hyperfractionation, Concomitant boost radiation therapy, Concurrent chemotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi Sci-Tech Office
- Study start
- Jan 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Oct 2008 (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.
Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of IMRT might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The study is designed to test if late-course accelerated hyperfractionated IMRT can improve the outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Radiation: Late-course accelerated hyperfractionated IMRT, Drug: Concomitant cisplatin chemotherapyLate-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy |
| B | Other | Drug: Concomitant cisplatin chemotherapy, Radiation: Conventionally fractionated IMRTConventionally fractionated IMRT with concomitant cisplatin chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven non-keratinizing or undifferentiated type nasopharyngeal carcinoma for primary treatment with curative intent
- According to AJCC 2002 Staging System, clinical stage must be Ⅱb-Ⅳb
- Age between 18-70
- Karnofsky performance status ≥70
- WBC ≥4,000/mm3, PLT ≥ 100,000/mm3,serum creatinine ≤ 1.6 mg/dl
Key exclusion criteria (4 listed)
- Patients with distant metastasis
- Pregnant or lactating women
- The presence of uncontrolled life-threatening illness
- Patients who received radiotherapy or chemotherapy previously
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 |
|---|---|---|
| Late-course accelerated hyperfractionated IMRT1. IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease 2. IMRT delivery scheduling: (1) Six-week treatment: PTV1=60Gy/30fractions, PTV2=57Gy/30fractions,PTV3=54Gy/30fractions.(2) Concomitant boost to PTV1 as a second daily treatment for the last 10 treatments of the Six-week treatment: PTV1=12Gy/10fractions.(3) PTV3 will be treated with conventional radiotherapy technique separately. | Radiation | A |
| Concomitant cisplatin chemotherapycisplatin:40mg/m2 weekly infusion for 6 weeks | Drug | A, B |
| Conventionally fractionated IMRTIMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Seven-week treatment: PTV1=70Gy/35fractions, PTV2=63Gy/35fractions,PTV3=55.8Gy/31fractions.(2) PTV3 will be treated with conventional radiotherapy technique separately. | Radiation | B |
Primary outcome
Local/regional control rate, Acute and late toxicities
Time frame: 2-Yr
1 secondary outcome
Overall survival rate
Time frame: 5-Yr
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 21 Aug 2012.
- Guangxi Sci-Tech OfficeLink provided by the sponsor.
- Guangxi Medical UniversityLink provided by the sponsor.
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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.
Heming Lu, MD study chair
Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Late-course accelerated hyperfractionated IMRT, Concomitant cisplatin chemotherapy and Conventionally fractionated IMRT in people with Nasopharyngeal Carcinoma, run by Guangxi Medical University 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 7 inclusion and 4 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 21 Aug 2012. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Local/regional control rate, Acute and late toxicities (time frame: 2-Yr). 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 21 Aug 2012.