Nasopharyngeal CarcinomaPhase 3IMRTNCT04136886
Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma
A Phase 3 study testing Cisplatin and IMRT in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone. 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?
- Cisplatin and IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;
- 2.No evidence of distant metastasis
- 3.More than 1 year from the end of the first course of radiotherapy
- 4.Male, or female not in the phase of lactating or pregnancy
- 5.ECOG 0-2
- 6.Aged 18-70 years old
Show all 9Show fewer
- 7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
- 8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
- 9.Written informed consort signed
Who cannot join
- Only regionally recurrence
- Evidence of distant metastasis
- Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
- Severe, active co-morbidity
- Prior anti-tumor treatment after diagnosis of local recurrence
- MRI was not performed 3 months after the first course of radiotherapy
Show all 9Show fewer
- Abnormal function of heart, brain and lungs, etc
- Lactation or pregnancy
- Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
WangHanYu
Guangzhou, Guangdong, 510060
HanYu wang, PHD, 008613925186898, why716@21cn.com
About this study
Official title: Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)
The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
Read the detailed description
Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Cisplatin, IMRT
- Keywords
- concurrent chemotherapy, IMRT, recurrent NPC
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction
IMRTRadiation
Radiation: IMRT IMRT is to give 60Gy in 27 fraction
| Study group | Role | What they receive |
|---|---|---|
| IMRT and concurrent cisplatin | Active comparator | IMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction Receives: Drug: Cisplatin; Radiation: IMRT |
| IMRT alone | Experimental | IMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction Receives: Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: From the beginning the IMRT to 3 year after the end of IMRT
Secondary outcomes (2)
Number of participants with severe acute toxicities as assessed by CTCAE v3.0
Measured: From the beginning of IMRT to 3 months after the end of IMRT
Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
Measured: From 3 months after the end of IMRT to 1 year after the end of IMRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Jan 2020 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- JiangXi Province Tumor Hospital, Fujian Province Tumor Hospital, SiChuan Province Tumor Hospital, Hunan Province Tumor Hospital, YuNan Province Tumor Hospital, GuiZhou Province Tumor Hospital, Hainan Cancer Hospital, Tongji Hospital, Second Affiliated Hospital of Nanchang University, Wuhan University, First Hospital of FoShan City
- Responsible party
- Principal investigator, Fei Han, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136886
- Sponsor's protocol ID
- B2019-070-01
- Acronym
- IMRT
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han F, Zhao C, Huang SM, Lu LX, Huang Y, Deng XW, Mai WY, Teh BS, Butler EB, Lu TX. Long-term outcomes and prognostic factors of re-irradiation for locally recurrent nasopharyngeal carcinoma using intensity-modulated radiotherapy. Clin Oncol (R Coll Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29.
PubMed 22209574Xiao WW, Huang SM, Han F, Wu SX, Lu LX, Lin CG, Deng XW, Lu TX, Cui NJ, Zhao C. Local control, survival, and late toxicities of locally advanced nasopharyngeal carcinoma treated by simultaneous modulated accelerated radiotherapy combined with cisplatin concurrent chemotherapy: long-term results of a phase 2 study. Cancer. 2011 May 1;117(9):1874-83. doi: 10.1002/cncr.25754. Epub 2010 Nov 16.
PubMed 21509764Seo Y, Yoo H, Yoo S, Cho C, Yang K, Kim MS, Choi C, Shin Y, Lee D, Lee G. Robotic system-based fractionated stereotactic radiotherapy in locally recurrent nasopharyngeal carcinoma. Radiother Oncol. 2009 Dec;93(3):570-4. doi: 10.1016/j.radonc.2009.10.018. Epub 2009 Nov 16.
PubMed 19919887Guan Y, Liu S, Wang HY, Guo Y, Xiao WW, Chen CY, Zhao C, Lu TX, Han F. Long-term outcomes of a phase II randomized controlled trial comparing intensity-modulated radiotherapy with or without weekly cisplatin for the treatment of locally recurrent nasopharyngeal carcinoma. Chin J Cancer. 2016 Feb 15;35:20. doi: 10.1186/s40880-016-0081-7.
PubMed 26879049
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)
- ClinicalTrials.gov ID
- NCT04136886
- Acronym / sponsor ID
- IMRT / B2019-070-01
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- concurrent chemotherapy, IMRT, recurrent NPC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- JiangXi Province Tumor Hospital, Fujian Province Tumor Hospital, SiChuan Province Tumor Hospital, Hunan Province Tumor Hospital, YuNan Province Tumor Hospital, GuiZhou Province Tumor Hospital, Hainan Cancer Hospital, Tongji Hospital, Second Affiliated Hospital of Nanchang University, Wuhan University, First Hospital of FoShan City
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Oct 2019 (actual)
- 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 purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
Detailed description
Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMRT and concurrent cisplatin | Active comparator | Drug: Cisplatin, Radiation: IMRTIMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction |
| IMRT alone | Experimental | Radiation: IMRTIMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;
- 2.No evidence of distant metastasis
- 3.More than 1 year from the end of the first course of radiotherapy
- 4.Male, or female not in the phase of lactating or pregnancy
- 5.ECOG 0-2
Key exclusion criteria (9 listed)
- Only regionally recurrence
- Evidence of distant metastasis
- Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
- Severe, active co-morbidity
- Prior anti-tumor treatment after diagnosis of local recurrence
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 |
|---|---|---|
| Cisplatincisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction | Drug | IMRT and concurrent cisplatin |
| IMRTRadiation: IMRT IMRT is to give 60Gy in 27 fraction | Radiation | IMRT alone, IMRT and concurrent cisplatin |
Primary outcome
Overall survival
Time frame: From the beginning the IMRT to 3 year after the end of IMRT
2 secondary outcomes
Number of participants with severe acute toxicities as assessed by CTCAE v3.0
Time frame: From the beginning of IMRT to 3 months after the end of IMRT
Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
Time frame: From 3 months after the end of IMRT to 1 year after the end of IMRT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Background: PubMed 22209574Han F, Zhao C, Huang SM, Lu LX, Huang Y, Deng XW, Mai WY, Teh BS, Butler EB, Lu TX. Long-term outcomes and prognostic factors of re-irradiation for locally recurrent nasopharyngeal carcinoma using intensity-modulated radiotherapy. Clin Oncol (R Coll Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29.
- Background: PubMed 21509764Xiao WW, Huang SM, Han F, Wu SX, Lu LX, Lin CG, Deng XW, Lu TX, Cui NJ, Zhao C. Local control, survival, and late toxicities of locally advanced nasopharyngeal carcinoma treated by simultaneous modulated accelerated radiotherapy combined with cisplatin concurrent chemotherapy: long-term results of a phase 2 study. Cancer. 2011 May 1;117(9):1874-83. doi: 10.1002/cncr.25754. Epub 2010 Nov 16.
- Background: PubMed 19919887Seo Y, Yoo H, Yoo S, Cho C, Yang K, Kim MS, Choi C, Shin Y, Lee D, Lee G. Robotic system-based fractionated stereotactic radiotherapy in locally recurrent nasopharyngeal carcinoma. Radiother Oncol. 2009 Dec;93(3):570-4. doi: 10.1016/j.radonc.2009.10.018. Epub 2009 Nov 16.
- Results publication: PubMed 26879049Guan Y, Liu S, Wang HY, Guo Y, Xiao WW, Chen CY, Zhao C, Lu TX, Han F. Long-term outcomes of a phase II randomized controlled trial comparing intensity-modulated radiotherapy with or without weekly cisplatin for the treatment of locally recurrent nasopharyngeal carcinoma. Chin J Cancer. 2016 Feb 15;35:20. doi: 10.1186/s40880-016-0081-7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin and IMRT in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 23 Oct 2019. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Han, doctor (8620-87343030, hanfei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From the beginning the IMRT to 3 year after the end of IMRT). 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 NCT04136886, which also lists 4 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 23 Oct 2019.