Adenoid Cystic CarcinomaPhase 2NCT02942693
Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma
A Phase 2 study testing Apatinib and Particle Therapy in people with Adenoid Cystic Carcinoma, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
It is a randomized phase II study to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adenoid Cystic Carcinoma
- What is being tested?
- Apatinib and Particle Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed ACC
- Inoperable disease or postoperative residual disease detected by imaging studies
- Age ≥ 18 and ≤ 65 years of age
- ECOG < 2, no significant active concurrent medical illnesses
- Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N > 2000/mm^3; PLT > 100,000/mm^3; total bilirubin < 1.5mg/dl; AST/ALT < 1.5 ULN; SCr < 1.5mg/dl; CCR > 60ml/min
- Willing to accept adequate contraception for women with childbearing potential
- Ability to understand character and individual consequences of the clinical trial
- Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial
Who cannot join
- Presence of distant metastasis
- Pregnant or lactating women
- A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years
- Refusal of the patient to participate into the study
Trial locations and contacts
1 site in 1 country.
Lin Kong, MD contact
Jiyi Hu, MD contact
China1 site, 1 recruiting
- Recruiting
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201315
Lin Kong, MD, lin.kong@sphic.org.cn
Jiyi Hu, MD, jiyi.hu@sphic.org.cn
About this study
Official title: A Phase II Randomized Trial of Efficacy and Safety of Particle Therapy With or Without Apatinib as Induction Therapy for Treatment of Head and Neck Adenoid Cystic Carcinoma
It is a randomized phase II study to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly followed by particle radiotherapy; arm 2: particle radiotherapy alone.
Read the detailed description
The purpose of this study is to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. It is a randomized phase II clinical trial with single phase and 2 experimental arms. Participants will be randomized to arm 1, receiving apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost); arm 2: particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). The short term response will be evaluated using RECIST criteria. And the acute and late toxicities will be evaluated according to NCI CTCAE v4.03.
- Conditions
- Adenoid Cystic Carcinoma
- Being tested
- Apatinib, Particle Therapy
- Keywords
- Apatinib, Particle therapy
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib will be used as induction therapy in experimental arm.
Particle TherapyRadiation
Same total dose and fractionation will be used in both arms.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib with Particle Therapy | Experimental | Participants will receive apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). Receives: Drug: Apatinib; Radiation: Particle Therapy |
| Particle Therapy | Experimental | Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). Receives: Radiation: Particle Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term treatment response of all patients
Measured: Three months after completion of particle therapy.
Secondary outcomes (5)
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03
Measured: Time interval from start to 3 months after completion of particle therapy.
Overall survival of all patients
Measured: From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years.
Progression-free survival of all patients
Measured: From the completion of the particle therapy, a median of 3 years.
Local progression-free survival of all patients
Measured: From the completion of the particle therapy, a median of 3 years.
Distant metastasis-free survival of all patients
Measured: From the completion of the particle therapy, a median of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid Cystic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiade J. Lu, Shanghai Proton and Heavy Ion Center
- Investigators
- Jiade J Lu, MD, Principal investigator, Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942693
- Sponsor's protocol ID
- SPHIC-TR-HNCNS-2016-08
- Status last verified
- Aug 2018
- First submitted
- 18 Oct 2016
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of Efficacy and Safety of Particle Therapy With or Without Apatinib as Induction Therapy for Treatment of Head and Neck Adenoid Cystic Carcinoma
- ClinicalTrials.gov ID
- NCT02942693
- Acronym / sponsor ID
- SPHIC-TR-HNCNS-2016-08
- Conditions
- Adenoid Cystic Carcinoma
- Keywords
- Apatinib, Particle therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 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.
It is a randomized phase II study to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly followed by particle radiotherapy; arm 2: particle radiotherapy alone.
Detailed description
The purpose of this study is to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. It is a randomized phase II clinical trial with single phase and 2 experimental arms. Participants will be randomized to arm 1, receiving apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost); arm 2: particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). The short term response will be evaluated using RECIST criteria. And the acute and late toxicities will be evaluated according to NCI CTCAE v4.03.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib with Particle Therapy | Experimental | Drug: Apatinib, Radiation: Particle TherapyParticipants will receive apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). |
| Particle Therapy | Experimental | Radiation: Particle TherapyParticipants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed ACC
- Inoperable disease or postoperative residual disease detected by imaging studies
- Age ≥ 18 and ≤ 65 years of age
- ECOG < 2, no significant active concurrent medical illnesses
- Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N > 2000/mm^3; PLT > 100,000/mm^3; total bilirubin < 1.5mg/dl; AST/ALT < 1.5 ULN; SCr < 1.5mg/dl; CCR > 60ml/min
Key exclusion criteria (4 listed)
- Presence of distant metastasis
- Pregnant or lactating women
- A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years
- Refusal of the patient to participate into the study
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 |
|---|---|---|
| ApatinibApatinib will be used as induction therapy in experimental arm. | Drug | Apatinib with Particle Therapy |
| Particle TherapySame total dose and fractionation will be used in both arms. | Radiation | Apatinib with Particle Therapy, Particle Therapy |
Primary outcome
Short-term treatment response of all patients
Time frame: Three months after completion of particle therapy.
5 secondary outcomes
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03
Time frame: Time interval from start to 3 months after completion of particle therapy.
Overall survival of all patients
Time frame: From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years.
Progression-free survival of all patients
Time frame: From the completion of the particle therapy, a median of 3 years.
Local progression-free survival of all patients
Time frame: From the completion of the particle therapy, a median of 3 years.
Distant metastasis-free survival of all patients
Time frame: From the completion of the particle therapy, a median of 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Lin Kong, MD contact
Jiyi Hu, MD contact
Jiade J Lu, MD principal investigator
Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
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 Apatinib and Particle Therapy in people with Adenoid Cystic Carcinoma, run by Shanghai Proton and Heavy Ion Center 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 4 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 28 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Kong, MD (lin.kong@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term treatment response of all patients (time frame: Three months after completion of particle therapy.). 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 28 Sep 2018.