Nasopharyngeal CarcinomaPhase 3NCT05527470
Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
A Phase 3 study testing Gemcitabine,Cisplatin, Intensity-modulated radiation therapy (IMRT) and Cisplatin in people with Nasopharyngeal Carcinoma, run by Wei Jiang at 2 sites in China.
Trial summary
In the era of comprehensive therapy, many studies have investigated the value of induction chemotherapy (IC) in the treatment of nasopharyngeal carcinoma (NPC). Concurrent cisplatin and radiotherapy is the foundation of concurrent chemoradiotherapy strategies, and the addition of cisplatin-based induction chemotherapy… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Gemcitabine,Cisplatin, 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
- 2 sitesChina
- Study dates
- 11 Nov 2022to 11 Nov 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 65 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 8th AJCC edition);
- No pregnant female;
- Age between 18-65;
- 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);
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- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001
Wei Jiang, PhD, +86-773-2882906, Weijiang@glmc.edu.cn
- Recruiting
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543002
Bin Zhang, MD, +86-0774-3827268, 304527598@qq.com
About this study
Official title: A Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
In the era of comprehensive therapy, many studies have investigated the value of induction chemotherapy (IC) in the treatment of nasopharyngeal carcinoma (NPC). Concurrent cisplatin and radiotherapy is the foundation of concurrent chemoradiotherapy strategies, and the addition of cisplatin-based induction chemotherapy to concurrent chemoradiotherapy (CCRT) is considered to prolong survival by reducing distant metastasis in patients with high-risk disease. However, the severity of acute toxicities was significantly increased, which can compromise quality of life and lead to interruptions in CCRT. Fortunately, Locoregional control has substantially improved 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, in the era of IMRT, whether patients with NPC benefit from IC plus radiotherapy alone and reduce toxicities compared with IC combined with CCRT. Therefore, the investigators propose this randomized phase III prospective study to assess the efficacy and contribution of IC plus radiotherapy alone in locoregionally advanced NPC during IMRT era.
Read the detailed description
Patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma will be randomized in a 1:1 ratio to experimental arm and active comparator arm. Patients in experimental arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. 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. Patients in active comparator arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. 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. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 3 cycles during IMRT.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Gemcitabine,Cisplatin, Intensity-modulated radiation therapy (IMRT), Cisplatin
- Keywords
- Nasopharyngeal Carcinoma, Chemoradiotherapy, Radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine,CisplatinDrug
Also called Induction chemotherapy regimen
Induction chemotherapy: Patients receive 1000 mg/m2 gemcitabine intravenously on day 1and day 8， 80mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.
Intensity-modulated radiation therapy (IMRT)Radiation
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 Concurrent chemotherapy regimen
Concurrent chemotherapy: Patients received 100mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Induction CT+IMRT Combined Concurrent CT | Active comparator | Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy Receives: Drug: Gemcitabine,Cisplatin; Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin |
| Induction CT+IMRT alone | Experimental | Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone Receives: Drug: Gemcitabine,Cisplatin; Radiation: Intensity-modulated radiation therapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression-free survival is from randomization to first disease progression [local recurrence and/or distant metastasis] or death from any cause
Measured: 3 years
Secondary outcomes (5)
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
Objective response rate
Objective response rate is the percentage of patients achieving complete response (CR) and partial response (PR) according to RECIST 1.1 criteria.
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 posted2 Sep 2022
- Study start11 Nov 2022
- Primary completion11 Nov 2025 (estimated)
- Study completion11 Nov 2027 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Induced Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Jiang
- Sponsor type
- University, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Lingshan County People's Hospital, Laibin People's Hospital, Nationalities Hospital of Guangxi Zhuang Autonomous Region
- Responsible party
- Sponsor-investigator, Wei Jiang, Guilin Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527470
- Sponsor's protocol ID
- GLMU-08
- Status last verified
- Apr 2023
- First submitted
- 30 Aug 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05527470
- Acronym / sponsor ID
- GLMU-08
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Chemoradiotherapy, Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Wei JiangUniversity, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Lingshan County People's Hospital, Laibin People's Hospital, Nationalities Hospital of Guangxi Zhuang Autonomous Region
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 11 Nov 2025 (estimated)
- Study completion
- 11 Nov 2027 (estimated)
- First posted
- 2 Sep 2022 (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.
In the era of comprehensive therapy, many studies have investigated the value of induction chemotherapy (IC) in the treatment of nasopharyngeal carcinoma (NPC). Concurrent cisplatin and radiotherapy is the foundation of concurrent chemoradiotherapy strategies, and the addition of cisplatin-based induction chemotherapy to concurrent chemoradiotherapy (CCRT) is considered to prolong survival by reducing distant metastasis in patients with high-risk disease. However, the severity of acute toxicities was significantly increased, which can compromise quality of life and lead to interruptions in CCRT. Fortunately, Locoregional control has substantially improved 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, in the era of IMRT, whether patients with NPC benefit from IC plus radiotherapy alone and reduce toxicities compared with IC combined with CCRT. Therefore, the investigators propose this randomized phase III prospective study to assess the efficacy and contribution of IC plus radiotherapy alone in locoregionally advanced NPC during IMRT era.
Detailed description
Patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma will be randomized in a 1:1 ratio to experimental arm and active comparator arm. Patients in experimental arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. 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. Patients in active comparator arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. 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. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 3 cycles during IMRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Induced Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
| Arm | Type | Receives |
|---|---|---|
| Induction CT+IMRT Combined Concurrent CT | Active comparator | Drug: Gemcitabine,Cisplatin, Radiation: Intensity-modulated radiation therapy (IMRT), Drug: CisplatinInduction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy |
| Induction CT+IMRT alone | Experimental | Drug: Gemcitabine,Cisplatin, Radiation: Intensity-modulated radiation therapy (IMRT)Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type);
- Tumor staged as III-IVb (according to the 8th AJCC edition);
- No pregnant female;
- Age between 18-65;
- Normal complete blood count level (hemoglobin >10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL);
Key exclusion criteria (4 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 |
|---|---|---|
| Gemcitabine,CisplatinAlso: Induction chemotherapy regimenInduction chemotherapy: Patients receive 1000 mg/m2 gemcitabine intravenously on day 1and day 8， 80mg/m2 cisplatin intravenously on day 1 to 3, 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)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: Concurrent chemotherapy regimenConcurrent chemotherapy: Patients received 100mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks. | Drug | Induction CT+IMRT Combined Concurrent CT |
Primary outcome
Progression-free Survival
Time frame: 3 years
Progression-free survival is from randomization to first disease progression [local recurrence and/or distant metastasis] or death from any cause
5 secondary outcomes
Overall Survival
Time frame: 3 years
Locoregional Failure-free Survival
Time frame: 3 years
Distant Failure-free Survival
Time frame: 3 years
Objective response rate
Time frame: 3 years
Number of Participants with Adverse Events
Time frame: 3 years
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 3 May 2023.
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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.
2 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 Gemcitabine,Cisplatin, Intensity-modulated radiation therapy (IMRT) and Cisplatin in people with Nasopharyngeal Carcinoma, run by Wei Jiang at 2 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 10 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: looking for participants now, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Wei Jiang, PhD (+86-2882906, weijiang@glmc.edu.cn), or a site near the patient. 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?
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 3 May 2023.