Salivary Gland TumorsPhase 1NCT02921984
Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
A Phase 1 study testing Docetaxel, Intensity-modulated radiotherapy and Pemetrexed 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
The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs. 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?
- Docetaxel, Intensity-modulated radiotherapy and Pemetrexed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Aug 2017
- Phase
- Phase 1
- 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
Show all 15Show fewer
- 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
The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs.
- Conditions
- Salivary Gland Tumors, Head and Neck Cancer
- Being tested
- Docetaxel, Intensity-modulated radiotherapy, Pemetrexed, Cisplatin
- Keywords
- Salivary Gland Tumors, Head and Neck Cancer, concurrent chemotherapy, genetic testing
- 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.
DocetaxelDrug
Docetaxel only: 80 mg/m2 on day one, every 21 days if
Intensity-modulated radiotherapyRadiation
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks
PemetrexedDrug
Pemetrexed only: 500 mg/m2 on day one, every 21 days
CisplatinDrug
Cisplatin only: 70 mg/m2 on day one to day three, every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel arm | Experimental | Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug. Receives: Drug: Docetaxel; Radiation: Intensity-modulated radiotherapy |
| Pemetrexed arm | Experimental | Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug. Receives: Radiation: Intensity-modulated radiotherapy; Drug: Pemetrexed |
| Cisplatin arm | Experimental | Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel Receives: Radiation: Intensity-modulated radiotherapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
Measured: up to 6 weeks
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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, Study chair, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921984
- Sponsor's protocol ID
- 2013HNRT01
- Status last verified
- Mar 2018
- First submitted
- 30 Sep 2016
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
- ClinicalTrials.gov ID
- NCT02921984
- Acronym / sponsor ID
- 2013HNRT01
- Conditions
- Salivary Gland Tumors, Head and Neck Cancer
- Keywords
- Salivary Gland Tumors, Head and Neck Cancer, concurrent chemotherapy, genetic testing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 3 Oct 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.
The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Docetaxel arm | Experimental | Drug: Docetaxel, Radiation: Intensity-modulated radiotherapyConcurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug. |
| Pemetrexed arm | Experimental | Radiation: Intensity-modulated radiotherapy, Drug: PemetrexedConcurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug. |
| Cisplatin arm | Experimental | Radiation: Intensity-modulated radiotherapy, Drug: CisplatinConcurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel |
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 |
|---|---|---|
| DocetaxelDocetaxel only: 80 mg/m2 on day one, every 21 days if | Drug | Docetaxel arm |
| Intensity-modulated radiotherapya total dose of 60-66Gy in 30-32 fractions over 6-7 weeks | Radiation | Cisplatin arm, Docetaxel arm, Pemetrexed arm |
| PemetrexedPemetrexed only: 500 mg/m2 on day one, every 21 days | Drug | Pemetrexed arm |
| CisplatinCisplatin only: 70 mg/m2 on day one to day three, every 21 days | Drug | Cisplatin arm |
Primary outcome
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
Time frame: up to 6 weeks
1 secondary outcome
Disease-free survival
Time frame: 2 years
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 20 Mar 2018.
- 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 study chair
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Docetaxel, Intensity-modulated radiotherapy and Pemetrexed 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 20 Mar 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 (time frame: up to 6 weeks). 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 20 Mar 2018.