Salivary Gland TumorsPhase 2NCT02776163
Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas
A Phase 2 study testing Nedaplatin, Docetaxel and Intensity-modulated radiotherapy in people with Salivary Gland Tumors and Head and Neck Cancer, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Salivary Gland Tumors, Head and Neck Cancer
- What is being tested?
- Nedaplatin, Docetaxel and Intensity-modulated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 31 Dec 2023
- Phase
- Phase 2
- 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
- Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
- Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
- Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
- No evidence of distant metastases
- No synchronous or concurrent head and neck primary tumors
- Karnofsky score over 60
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- Adequate organ function including the following:
- Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
- Platelets count >= 100 * 10^9/l
- Hemoglobin >= 10 g/dl
- AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
- Total bilirubin <= 1.5 times institutional ULN
- Creatinine clearance >= 50 ml/min
- Serum creatine <= 1 times ULN
- Signed written informed consent
Who cannot join
- Evidence of distant metastasis
- Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas of Head and Neck, A Non-Randomized, Phase II Trial
This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.
- Conditions
- Salivary Gland Tumors, Head and Neck Cancer
- Being tested
- Nedaplatin, Docetaxel, Intensity-modulated radiotherapy
- Keywords
- Salivary Gland Tumors, Head-an-Neck cancer, Concurrent Chemoradiotherapy, High-Risk, Cisplatin, Docetaxel
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NedaplatinDrug
nedaplatin 35mg/m^2，D1-2，2 cycles
DocetaxelDrug
Docetaxel 70mg/m^2，D1，2 cycles
Intensity-modulated radiotherapyRadiation
a total dose of 60-66Gy in 30-33 fractions over 6-7 weeks
| Study group | Role | What they receive |
|---|---|---|
| ACC | Experimental | Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin Receives: Drug: Nedaplatin; Drug: Docetaxel; Radiation: Intensity-modulated radiotherapy |
| Non-ACC | Experimental | Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin Receives: Drug: Nedaplatin; Drug: Docetaxel; Radiation: Intensity-modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Measured: 2 years
Secondary outcomes (4)
Overall survival rate
from date of enrollment until date of first death from any cause, assessed up to 2 years
Measured: 2 years
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment
Measured: up to 6 weeks
Late toxicity profiles, graded according to the NCI CTCAE version 3.0
Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years
Measured: up to 2 years
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
QoL score will be documented on each weekend during the course of radiotherapy
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start1 Jun 2016
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
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 Salivary Gland TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Guopei Zhu, M.D., Principal investigator, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776163
- Sponsor's protocol ID
- 2016HNRT002
- Status last verified
- Jul 2024
- First submitted
- 12 May 2016
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dou S, Wang X, Zhang L, Jiang W, Ye L, Wang Y, Li R, Zhu G. Long-Term Survival Outcomes of Concurrent Chemoradiotherapy for Postoperative High-Risk Salivary Gland Carcinomas. Cancer Med. 2026 Mar;15(3):e71722. doi: 10.1002/cam4.71722.
PubMed 41878954
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas of Head and Neck, A Non-Randomized, Phase II Trial
- ClinicalTrials.gov ID
- NCT02776163
- Acronym / sponsor ID
- 2016HNRT002
- Conditions
- Salivary Gland Tumors, Head and Neck Cancer
- Keywords
- Salivary Gland Tumors, Head-an-Neck cancer, Concurrent Chemoradiotherapy, High-Risk, Cisplatin, Docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 May 2016 (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.
This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACC | Experimental | Drug: Nedaplatin, Drug: Docetaxel, Radiation: Intensity-modulated radiotherapyIntensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin |
| Non-ACC | Experimental | Drug: Nedaplatin, Drug: Docetaxel, Radiation: Intensity-modulated radiotherapyIntensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
- Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
- Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
- No evidence of distant metastases
- No synchronous or concurrent head and neck primary tumors
Key exclusion criteria (5 listed)
- Evidence of distant metastasis
- Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
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 |
|---|---|---|
| Nedaplatinnedaplatin 35mg/m^2，D1-2，2 cycles | Drug | ACC, Non-ACC |
| DocetaxelDocetaxel 70mg/m^2，D1，2 cycles | Drug | ACC, Non-ACC |
| Intensity-modulated radiotherapya total dose of 60-66Gy in 30-33 fractions over 6-7 weeks | Radiation | ACC, Non-ACC |
Primary outcome
Disease-free survival
Time frame: 2 years
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
4 secondary outcomes
Overall survival rate
Time frame: 2 years
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
Time frame: up to 6 weeks
Late toxicity profiles, graded according to the NCI CTCAE version 3.0
Time frame: up to 2 years
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 41878954Dou S, Wang X, Zhang L, Jiang W, Ye L, Wang Y, Li R, Zhu G. Long-Term Survival Outcomes of Concurrent Chemoradiotherapy for Postoperative High-Risk Salivary Gland Carcinomas. Cancer Med. 2026 Mar;15(3):e71722. doi: 10.1002/cam4.71722.
- Individual participant dataSharing planned: No
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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.
Guopei Zhu, M.D. principal investigator
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nedaplatin, Docetaxel and Intensity-modulated radiotherapy in people with Salivary Gland Tumors and Head and Neck Cancer, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 15 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: finished, as of the sponsor's last update on 30 Jul 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease-free survival (time frame: 2 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 NCT02776163, 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 30 Jul 2024.