Nasopharyngeal CarcinomaPhase 3NCT04766359
Paclitaxel (Albumin-bound) Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma
A Phase 3 study testing Albumin-Bound Paclitaxel in people with Nasopharyngeal Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
This trial is a prospective, parallel controlled, randomized, open, multi-center phase III clinical trial. The trial will enroll 364 patients with nasopharyngeal carcinoma who are staged T1-2N0-1M0 (except T1N0M0) (UICC 8th edition) . 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?
- Albumin-Bound Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Aug 2025
- 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
- Differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma confirmed by pathology;
- The staging is T1-2N0-1M0 (except T1N0M0) (UICC 8th edition);
- Initial treatment patients who have not received anti-tumor therapy;
- No history of other malignant tumors;
- Male or female, aged 18 to 70 years old;
- Liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min;
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- Neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
- No serious heart, lung, liver, kidney and other important organ dysfunction;
- Karnofsky score ≥70 points;
- Sign the informed consent form;
- Able to follow research protocols and follow-up procedures.
Who cannot join
- Anti-tumor treatment has been performed, including chemotherapy, radiotherapy, and surgery;
- Find distant metastases before treatment;
- Women who are pregnant or breastfeeding;
- Disagree to sign the informed consent form;
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons;
- Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research);
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- Known to be allergic to possible chemotherapy drugs;
- Patients with other malignant tumors;
- Accompanied by severe uncontrollable infections or medical diseases, including autoimmune diseases;
- Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate radiotherapy and chemotherapy;
- Laboratory examination: total bilirubin>upper limit of normal (ULN); AST and/or ALT>1.5 times ULN and accompanied by alkaline phosphatase>2.5 times ULN;
- Any uncertain factors that affect patient safety or compliance.
About this study
Official title: Paclitaxel (Albumin-bound) Combined With Radiotherapy Compared With Cisplatin Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma: a Prospective, Parallel-controlled, Multicenter Phase III Clinical Study
This trial is a prospective, parallel controlled, randomized, open, multi-center phase III clinical trial. The trial will enroll 364 patients with nasopharyngeal carcinoma who are staged T1-2N0-1M0 (except T1N0M0) (UICC 8th edition) . This experiment was participated by multiple centers of Nanjing Gulou Hospital, Jiangsu Provincial People's Hospital, Jiangsu Cancer Hospital, Nanjing Military Region General Hospital, Jiangsu Provincial Hospital of Traditional Chinese Medicine, and Zhongda Hospital. Each center competes for admission of cases.
The subjects will be randomly assigned (using the random number table method according to the order of entry) to the experimental group to receive albumin-bound paclitaxel combined with IMRT concurrent radiotherapy, or the control group to receive cisplatin combined with IMRT concurrent radiotherapy.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Albumin-Bound Paclitaxel
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin-Bound PaclitaxelDrug
Also called Cisplatin, Radiotherapy
Compare the effectiveness and safety of paclitaxel (albumin-bound) combined with radiotherapy and cisplatin combined with radiotherapy in the treatment of early nasopharyngeal carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Albumin-Bound paclitaxel combined with radiotherapy | Experimental | Albumin paclitaxel (100mg/m2), D1 intravenous drip, start the first week of radiotherapy, use it continuously for 4-6 weeks.
Radiotherapy: The total dose is 66-70Gy, divided into 33-35 times to complete. Receives: Drug: Albumin-Bound Paclitaxel |
| Cisplatin combined with radiotherapy | Experimental | Cisplatin (40mg/m2), D1 intravenous drip, start the first week of radiotherapy, use it continuously for 4-6 weeks.
Radiotherapy: The total dose is 66-70Gy, divided into 33-35 times to complete. Receives: Drug: Albumin-Bound Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Nasopharyngeal + neck MRI and nasopharyngoscopy: the nasopharyngeal mass disappeared; the nasopharyngeal mucosa was smooth and no lesions were seen on the nasopharyngoscope. The tumor is clinically considered to have completely subsided. Neck MRI showed complete regression of cervical lymph nodes, or combined with clinical findings that the lymph node lesions completely resolved.
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (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.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766359
- Sponsor's protocol ID
- 2020-236-02
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 23 Feb 2021
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel (Albumin-bound) Combined With Radiotherapy Compared With Cisplatin Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma: a Prospective, Parallel-controlled, Multicenter Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT04766359
- Acronym / sponsor ID
- 2020-236-02
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 23 Feb 2021 (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.
This trial is a prospective, parallel controlled, randomized, open, multi-center phase III clinical trial. The trial will enroll 364 patients with nasopharyngeal carcinoma who are staged T1-2N0-1M0 (except T1N0M0) (UICC 8th edition) . This experiment was participated by multiple centers of Nanjing Gulou Hospital, Jiangsu Provincial People's Hospital, Jiangsu Cancer Hospital, Nanjing Military Region General Hospital, Jiangsu Provincial Hospital of Traditional Chinese Medicine, and Zhongda Hospital. Each center competes for admission of cases.
The subjects will be randomly assigned (using the random number table method according to the order of entry) to the experimental group to receive albumin-bound paclitaxel combined with IMRT concurrent radiotherapy, or the control group to receive cisplatin combined with IMRT concurrent radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin-Bound paclitaxel combined with radiotherapy | Experimental | Drug: Albumin-Bound PaclitaxelAlbumin paclitaxel (100mg/m2), D1 intravenous drip, start the first week of radiotherapy, use it continuously for 4-6 weeks. Radiotherapy: The total dose is 66-70Gy, divided into 33-35 times to complete. |
| Cisplatin combined with radiotherapy | Experimental | Drug: Albumin-Bound PaclitaxelCisplatin (40mg/m2), D1 intravenous drip, start the first week of radiotherapy, use it continuously for 4-6 weeks. Radiotherapy: The total dose is 66-70Gy, divided into 33-35 times to complete. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma confirmed by pathology;
- The staging is T1-2N0-1M0 (except T1N0M0) (UICC 8th edition);
- Initial treatment patients who have not received anti-tumor therapy;
- No history of other malignant tumors;
- Male or female, aged 18 to 70 years old;
Key exclusion criteria (12 listed)
- Anti-tumor treatment has been performed, including chemotherapy, radiotherapy, and surgery;
- Find distant metastases before treatment;
- Women who are pregnant or breastfeeding;
- Disagree to sign the informed consent form;
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons;
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 |
|---|---|---|
| Albumin-Bound PaclitaxelAlso: Cisplatin, RadiotherapyCompare the effectiveness and safety of paclitaxel (albumin-bound) combined with radiotherapy and cisplatin combined with radiotherapy in the treatment of early nasopharyngeal carcinoma. | Drug | Albumin-Bound paclitaxel combined with radiotherapy, Cisplatin combined with radiotherapy |
Primary outcome
Objective response rate
Time frame: 1month
Nasopharyngeal + neck MRI and nasopharyngoscopy: the nasopharyngeal mass disappeared; the nasopharyngeal mucosa was smooth and no lesions were seen on the nasopharyngoscope. The tumor is clinically considered to have completely subsided. Neck MRI showed complete regression of cervical lymph nodes, or combined with clinical findings that the lymph node lesions completely resolved.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albumin-Bound Paclitaxel in people with Nasopharyngeal Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 11 inclusion and 12 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 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Objective response rate (time frame: 1month). 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 23 Feb 2021.