Nasopharyngeal CarcinomaPhase 3NCT03366415
Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC
A Phase 3 study testing gemcitabine and cisplatin (Induction and adjuvant chemotherapy), IMRT and gemcitabine and cisplatin (Induction chemotherapy) in people with Nasopharyngeal Carcinoma, run by Chaosu Hu at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in… 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 and cisplatin (Induction and adjuvant chemotherapy), IMRT and gemcitabine and cisplatin (Induction chemotherapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Dec 2024
- 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 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-IVA (according to the 8th AJCC edition).
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
- Age between 18 and 65 years old.
- Adequate marrow: Neutrophil count ≥2000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
- Adequate renal function: creatinine clearance ≥60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Who cannot join
- Evidence of distant metastasis
- Prior chemotherapy, radiotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Other previous or concomitant cancer.
- Pregnancy or lactation.
- Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, immune deficiency, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or emotional disturbance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Chaosu Hu, MD,PhD, +86 18017312302
About this study
Official title: Non-inferiority Prospective Randomized Trial Comparing Sequential Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
The purpose of this study is to compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of sequential chemoradiotherapy in NPC patients.
Read the detailed description
Patients with non-keratinizing NPC III-IVA (UICC/AJCC 8th edition) are randomly assigned to receive sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy + adjuvant chemotherapy) or induction chemotherapy plus concurrent chemoradiotherapy. Intensity-modulated radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor. The induction or adjuvant chemotherapy is given gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for two cycles. The concurrent chemotherapy is given cisplatin 30 mg/m² every week concurrently with IMRT. Our primary endpoint is failure-free survival(FFS) and grade III mucositis during radiation. Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- gemcitabine and cisplatin (Induction and adjuvant chemotherapy), IMRT, gemcitabine and cisplatin (Induction chemotherapy), IMRT and concurrent cisplatin
- Keywords
- Nasopharyngeal Carcinoma, concurrent chemoradiotherapy, sequential chemoradiotherapy
- 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 and cisplatin (Induction and adjuvant chemotherapy)Drug
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before IMRT and after IMRT.
IMRTRadiation
Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor
gemcitabine and cisplatin (Induction chemotherapy)Drug
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before concurrent chemoradiotherapy.
IMRT and concurrent cisplatinRadiation
Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4Gy to the primary tumor, concurrently with cisplatin 30mg/m² every week.
| Study group | Role | What they receive |
|---|---|---|
| Induction chemotherapy+IMRT+adjuvant chemotherapy | Experimental | Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), followed by gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles. Receives: Drug: gemcitabine and cisplatin (Induction and adjuvant chemotherapy); Radiation: IMRT |
| Induction chemotherapy+IMRT and concurrent cisplatin | Active comparator | Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 30 mg/m² every week. Receives: Drug: gemcitabine and cisplatin (Induction chemotherapy); Radiation: IMRT and concurrent cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival
Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
Measured: 3-year
Grade III or more mucositis
Grade III or more mucositis during radiotherapy
Measured: From the start of radiotherapy to 30 days after radiotherapy
Secondary outcomes (6)
Overall survival
Overall survival is calculated from randomization to death from any cause.
Measured: 3-year
Locoregional failure-free survival
Locoregional failure-free survival is calculated from randomization to the first locoregional failure.
Measured: 3-year
Distant failure-free survival
Distant failure-free survival is calculated from randomization to the first remote failure.
Measured: 3-year
Short-term treatment response
Treatment response after induction chemotherapy, IMRT and completion of treatment.
Measured: Two weeks after completion of induction chemotherapy. Three months after completion of the radiotherapy.
Number of participants with adverse events
Incidence of acute and late toxicity
Measured: up to 3 years
Quality of Life
Use EORTC QLQ-HN35.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Jan 2018
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (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
- Model description
- Stratified by stage
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaosu Hu
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Jiangxi Provincial Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Affiliated Hospital of Jiangnan University, Fujian Cancer Hospital
- Responsible party
- Sponsor-investigator, Chaosu Hu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366415
- Sponsor's protocol ID
- GP2017-02（SANDWICH）
- Status last verified
- Feb 2022
- First submitted
- 2 Dec 2017
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xue F, Ou D, Xie C, Lin S, Li J, Chen X, Zhang F, Ying H, Lu X, Shen C, Xu T, Ou X, Li W, Zhou X, Du C, Zhou C, Hu C, He X. Sequential vs Induction Plus Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2025 Jul 24;11(9):1011-20. doi: 10.1001/jamaoncol.2025.2191. Online ahead of print.
PubMed 40705321
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Prospective Randomized Trial Comparing Sequential Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03366415
- Acronym / sponsor ID
- GP2017-02（SANDWICH）
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, concurrent chemoradiotherapy, sequential chemoradiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Chaosu HuUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Jiangxi Provincial Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Affiliated Hospital of Jiangnan University, Fujian Cancer Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 Dec 2017 (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 compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of sequential chemoradiotherapy in NPC patients.
Detailed description
Patients with non-keratinizing NPC III-IVA (UICC/AJCC 8th edition) are randomly assigned to receive sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy + adjuvant chemotherapy) or induction chemotherapy plus concurrent chemoradiotherapy. Intensity-modulated radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor. The induction or adjuvant chemotherapy is given gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for two cycles. The concurrent chemotherapy is given cisplatin 30 mg/m² every week concurrently with IMRT. Our primary endpoint is failure-free survival(FFS) and grade III mucositis during radiation. Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stratified by stage
| Arm | Type | Receives |
|---|---|---|
| Induction chemotherapy+IMRT+adjuvant chemotherapy | Experimental | Drug: gemcitabine and cisplatin (Induction and adjuvant chemotherapy), Radiation: IMRTPatients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), followed by gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles. |
| Induction chemotherapy+IMRT and concurrent cisplatin | Active comparator | Drug: gemcitabine and cisplatin (Induction chemotherapy), Radiation: IMRT and concurrent cisplatinPatients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 30 mg/m² every week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type)
- Tumor staged as III-IVA (according to the 8th AJCC edition).
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
- Age between 18 and 65 years old.
- Adequate marrow: Neutrophil count ≥2000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
Key exclusion criteria (5 listed)
- Evidence of distant metastasis
- Prior chemotherapy, radiotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Other previous or concomitant cancer.
- Pregnancy or lactation.
- Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, immune deficiency, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or emotional disturbance.
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 and cisplatin (Induction and adjuvant chemotherapy)Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before IMRT and after IMRT. | Drug | Induction chemotherapy+IMRT+adjuvant chemotherapy |
| IMRTIntensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor | Radiation | Induction chemotherapy+IMRT+adjuvant chemotherapy |
| gemcitabine and cisplatin (Induction chemotherapy)Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before concurrent chemoradiotherapy. | Drug | Induction chemotherapy+IMRT and concurrent cisplatin |
| IMRT and concurrent cisplatinIntensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4Gy to the primary tumor, concurrently with cisplatin 30mg/m² every week. | Radiation | Induction chemotherapy+IMRT and concurrent cisplatin |
Primary outcome
Failure-free survival
Time frame: 3-year
Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
Grade III or more mucositis
Time frame: From the start of radiotherapy to 30 days after radiotherapy
Grade III or more mucositis during radiotherapy
6 secondary outcomes
Overall survival
Time frame: 3-year
Locoregional failure-free survival
Time frame: 3-year
Distant failure-free survival
Time frame: 3-year
Short-term treatment response
Time frame: Two weeks after completion of induction chemotherapy. Three months after completion of the radiotherapy.
Number of participants with adverse events
Time frame: up to 3 years
Quality of Life
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 40705321Xue F, Ou D, Xie C, Lin S, Li J, Chen X, Zhang F, Ying H, Lu X, Shen C, Xu T, Ou X, Li W, Zhou X, Du C, Zhou C, Hu C, He X. Sequential vs Induction Plus Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2025 Jul 24;11(9):1011-20. doi: 10.1001/jamaoncol.2025.2191. Online ahead of print.
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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.
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 gemcitabine and cisplatin (Induction and adjuvant chemotherapy), IMRT and gemcitabine and cisplatin (Induction chemotherapy) in people with Nasopharyngeal Carcinoma, run by Chaosu Hu 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 8 inclusion and 5 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 4 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chaosu Hu, MD,PhD (+86 18017312302, hucsu62@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free survival (time frame: 3-year). The study lists 2 primary outcomes in all. 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 NCT03366415, 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 4 Mar 2022.