Nasopharyngeal CarcinomaPhase 3NCT02434614
Induction Chemotherapy Followed by IMRT With or Without Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
A Phase 3 study testing Docetaxel,Cisplatin,Fluorouracil, Intensity-modulated radiation therapy (IMRT) and Cisplatin in people with Nasopharyngeal Carcinoma, run by Wei Jiang at 6 sites in China.
Trial summary
Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). 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?
- Docetaxel,Cisplatin,Fluorouracil, Intensity-modulated radiation therapy (IMRT) and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 6 sitesChina
- Study dates
- Mar 2015to Dec 2021
- Phase
- Phase 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
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type); Tumor staged as III-IVb (according to the 7th AJCC edition); No pregnant female; Age between 18-70; Normal complete blood count level (hemoglobin >10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL); Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase < 2.5 times higher than upper limit); Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min); Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Without radiotherapy or chemotherapy; Patients must give signed informed consent.
Who cannot join
- Disease progression in the process of the treatment; The presence of uncontrolled life-threatening illness; History of previous radiotherapy or chemotherapy; Pregnancy or lactation.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, Guangxi
Guigang People's Hospital
Guigang, Guangxi
Guangxi Naxishan Hospital
Guilin, Guangxi
Liuzhou People's Hospital
Liuzhou, Guangxi
Nanning Monority Hospital
Nanning, Guangxi
Wuzhou Red Cross Hospital
Wuzhou, Guangxi
About this study
Official title: A Randomized Phase III Non-inferiority Study of Induction Chemotherapy Followed by IMRT Alone Versus Induction Chemotherapy Followed by IMRT Plus Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). Based on these evidences, concurrent chemoradiotherapy (CCRT) with/without sequential chemotherapy has become the standard care for locoregionally advanced NPC. However, most of these evidences of standard treatment for locoregionally advanced NPC were based on the two-dimensional conventional radiotherapy (2DCRT). As the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, more retrospective studies compared the IMRT alone vs. IMRT plus concurrent chemotherapy, and reported that concurrent chemotherapy failed to improve survival rates for patients with locoregionally advanced disease, but increased the severity of acute toxicities. People started to reconsider the role of CCRT. Therefore, we propose this randomized phase III non-inferiority study to reassess the efficacy and contribution of concurrent chemotherapy in locoregionally advanced NPC during IMRT era.
Read the detailed description
Patients with with previously untreated non-metastatic newly histologically-confirmed non-keratinizing III-IVb NPC (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy followed by IMRT alone (investigational group) or induction chemotherapy followed by IMRT plus concurrent chemotherapy (control group). During induction chemotherapy, patients in both groups receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks. During radiotherapy, patients in investigational group received IMRT alone and patients in control group received IMRT, concurrently with weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks. IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration. The primary endpoint is failure-free survival(FFS). Secondary clinical endpoints include overall survival (OS), locoregional failure-free survival (LRFFS), distant failure-free survival (DFFS) rates and toxic effects.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Docetaxel,Cisplatin,Fluorouracil, Intensity-modulated radiation therapy (IMRT), Cisplatin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel,Cisplatin,FluorouracilDrug
Also called No.
Induction chemotherapy: patients receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks.
Intensity-modulated radiation therapy (IMRT)Radiation
Also called No.
IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration.
CisplatinDrug
Also called No.
Concurrent chemotherapy: patients received weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Induction CT+IMRT alone | Experimental | Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone Receives: Drug: Docetaxel,Cisplatin,Fluorouracil; Radiation: Intensity-modulated radiation therapy (IMRT) |
| Induction CT+IMRT Combined Concurrent CT | Active comparator | Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy Receives: Drug: Docetaxel,Cisplatin,Fluorouracil; Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression-free survival is to first disease progression [local recurrence and/or distant metastasis] or death from any cause.
Measured: 3 years
Secondary outcomes (4)
Overall Survival
Overall survival is from randomization to death of any cause or last follow-up.
Measured: 3 years
Locoregional Failure-free Survival
Locoregional failure-free survival is from randomization to locoregional progression.
Measured: 3 years
Distant Failure-free Survival
Distant failure-free survival is from randomization to first distant metastasis.
Measured: 3 years
Number of Participants with Adverse Events
Incidence of acute and late toxicity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei Jiang
- Sponsor type
- University, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Guangxi Naxishan Hospital, LiuZhou People's Hospital, Guigang People's Hospital, Youjiang Medical College for Nationalities, Nanning Monority Hospital
- Responsible party
- Sponsor-investigator, Wei Jiang, Guilin Medical University, China
- Investigators
- Wei Jiang, Ph.D., Study director, Guilin Medical University Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434614
- Sponsor's protocol ID
- GLMU-01
- Status last verified
- May 2018
- First submitted
- 27 Apr 2015
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dai J, Zhang B, Su Y, Pan Y, Ye Z, Cai R, Qin G, Kong X, Mo Y, Zhang R, Liu Z, Xie Y, Ruan X, Jiang W. Induction Chemotherapy Followed by Radiotherapy vs Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):456-463. doi: 10.1001/jamaoncol.2023.6552.
PubMed 38329737
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Non-inferiority Study of Induction Chemotherapy Followed by IMRT Alone Versus Induction Chemotherapy Followed by IMRT Plus Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02434614
- Acronym / sponsor ID
- GLMU-01
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Wei JiangUniversity, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Guangxi Naxishan Hospital, LiuZhou People's Hospital, Guigang People's Hospital, Youjiang Medical College for Nationalities, Nanning Monority Hospital
- Study start
- Mar 2015
- Primary completion
- May 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 May 2015 (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.
Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). Based on these evidences, concurrent chemoradiotherapy (CCRT) with/without sequential chemotherapy has become the standard care for locoregionally advanced NPC. However, most of these evidences of standard treatment for locoregionally advanced NPC were based on the two-dimensional conventional radiotherapy (2DCRT). As the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, more retrospective studies compared the IMRT alone vs. IMRT plus concurrent chemotherapy, and reported that concurrent chemotherapy failed to improve survival rates for patients with locoregionally advanced disease, but increased the severity of acute toxicities. People started to reconsider the role of CCRT. Therefore, we propose this randomized phase III non-inferiority study to reassess the efficacy and contribution of concurrent chemotherapy in locoregionally advanced NPC during IMRT era.
Detailed description
Patients with with previously untreated non-metastatic newly histologically-confirmed non-keratinizing III-IVb NPC (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy followed by IMRT alone (investigational group) or induction chemotherapy followed by IMRT plus concurrent chemotherapy (control group). During induction chemotherapy, patients in both groups receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks. During radiotherapy, patients in investigational group received IMRT alone and patients in control group received IMRT, concurrently with weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks. IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration. The primary endpoint is failure-free survival(FFS). Secondary clinical endpoints include overall survival (OS), locoregional failure-free survival (LRFFS), distant failure-free survival (DFFS) rates and toxic effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction CT+IMRT alone | Experimental | Drug: Docetaxel,Cisplatin,Fluorouracil, Radiation: Intensity-modulated radiation therapy (IMRT)Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone |
| Induction CT+IMRT Combined Concurrent CT | Active comparator | Drug: Docetaxel,Cisplatin,Fluorouracil, Radiation: Intensity-modulated radiation therapy (IMRT), Drug: CisplatinInduction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type); Tumor staged as III-IVb (according to the 7th AJCC edition); No pregnant female; Age between 18-70; Normal complete blood count level (hemoglobin >10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL); Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase < 2.5 times higher than upper limit); Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min); Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Without radiotherapy or chemotherapy; Patients must give signed informed consent.
Key exclusion criteria (1 listed)
- Disease progression in the process of the treatment; The presence of uncontrolled life-threatening illness; History of previous radiotherapy or chemotherapy; Pregnancy or lactation.
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 |
|---|---|---|
| Docetaxel,Cisplatin,FluorouracilAlso: No.Induction chemotherapy: patients receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks. | Drug | Induction CT+IMRT Combined Concurrent CT, Induction CT+IMRT alone |
| Intensity-modulated radiation therapy (IMRT)Also: No.IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration. | Radiation | Induction CT+IMRT Combined Concurrent CT, Induction CT+IMRT alone |
| CisplatinAlso: No.Concurrent chemotherapy: patients received weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks. | Drug | Induction CT+IMRT Combined Concurrent CT |
Primary outcome
Progression-free Survival
Time frame: 3 years
Progression-free survival is to first disease progression [local recurrence and/or distant metastasis] or death from any cause.
4 secondary outcomes
Overall Survival
Time frame: 3 years
Locoregional Failure-free Survival
Time frame: 3 years
Distant Failure-free Survival
Time frame: 3 years
Number of Participants with Adverse Events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 38329737Dai J, Zhang B, Su Y, Pan Y, Ye Z, Cai R, Qin G, Kong X, Mo Y, Zhang R, Liu Z, Xie Y, Ruan X, Jiang W. Induction Chemotherapy Followed by Radiotherapy vs Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):456-463. doi: 10.1001/jamaoncol.2023.6552.
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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.
Wei Jiang, Ph.D. study director
Guilin Medical University Affiliated Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel,Cisplatin,Fluorouracil, Intensity-modulated radiation therapy (IMRT) and Cisplatin in people with Nasopharyngeal Carcinoma, run by Wei Jiang at 6 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 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: status not confirmed, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
Results are not available in the source record.
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?
Progression-free Survival (time frame: 3 years). 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 NCT02434614, which also lists 1 linked publication.
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 16 May 2018.