Nasopharyngeal CarcinomaNCT04158518
De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma
A study testing Toxicities reduced treatment and Conventional treatment in people with Nasopharyngeal Carcinoma, run by Chaosu Hu at 1 site in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction… 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?
- Toxicities reduced treatment and Conventional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 31 Dec 2022
- Phase
- Interventional
- 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
- Histological diagnosis of nasopharyngeal carcinoma
- Stage III or IVA according to UICC/AJCC 8th staging system
- Age ≥18
- No prior anti-tumor treatment
- Karnofsky Performance Score (KPS)≥70
- Adequate blood supply
- Informed consent obtained
Who cannot join
- Can not take contrast-MRI imaging
- Pregnant
- Combined with other malignant tumor (except basal cell carcinoma of skin)
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan Universtiy Shanghai Cancer Centre
Shanghai
Youqi Yang, MD, +8613916162859, yangyq@sina.com
Xueguan Lu, MD, +8618121299382, luxueguan@163.com
About this study
Official title: De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Toxicities reduced treatment, Conventional treatment
- Keywords
- Nasopharyngeal Carcinoma, De-escalation
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toxicities reduced treatmentRadiation
Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.
Omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).
Radiation: IMRT 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.
Conventional treatmentRadiation
Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.
Concurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR).
Radiation: IMRT 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.
| Study group | Role | What they receive |
|---|---|---|
| Toxicities reduced treatment | Experimental | Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR). Receives: Radiation: Toxicities reduced treatment |
| Conventional treatment | Active comparator | Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR). Receives: Radiation: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease Free Survival
Measured: 3 year
Secondary outcomes (1)
OS
Overall Survival
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Nov 2019 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaosu Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chaosu Hu, Fudan University
- Investigators
- Chaosu Hu, MD, Principal investigator, Fudan University Shanghai Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158518
- Sponsor's protocol ID
- 2019-NPC001
- Status last verified
- Nov 2019
- First submitted
- 7 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04158518
- Acronym / sponsor ID
- 2019-NPC001
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, De-escalation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Chaosu HuUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Nov 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 explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toxicities reduced treatment | Experimental | Radiation: Toxicities reduced treatmentPatients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR). |
| Conventional treatment | Active comparator | Radiation: Conventional treatmentPatients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological diagnosis of nasopharyngeal carcinoma
- Stage III or IVA according to UICC/AJCC 8th staging system
- Age ≥18
- No prior anti-tumor treatment
- Karnofsky Performance Score (KPS)≥70
Key exclusion criteria (3 listed)
- Can not take contrast-MRI imaging
- Pregnant
- Combined with other malignant tumor (except basal cell carcinoma of skin)
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 |
|---|---|---|
| Toxicities reduced treatmentDrug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT. Omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR). Radiation: IMRT 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. | Radiation | Toxicities reduced treatment |
| Conventional treatmentDrug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT. Concurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR). Radiation: IMRT 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. | Radiation | Conventional treatment |
Primary outcome
DFS
Time frame: 3 year
Disease Free Survival
1 secondary outcome
OS
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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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.
Chaosu Hu, MD principal investigator
Fudan University Shanghai Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toxicities reduced treatment and Conventional treatment 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 7 inclusion and 3 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 8 Nov 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.
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 Youqi Yang, MD (+8613916162859, yangyq@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 3 year). 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 8 Nov 2019.