Head and Neck NeoplasmsNCT01447134
RGD-K5 in Head and Neck Cancer Patients
An observational study of Head and Neck Neoplasms, run by Chang Gung Memorial Hospital.
Trial summary
1. Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients. 2. Secondary endpoint(s): To expand the safety database of [F-18]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2014
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified.
Who may be able to join
- Head and neck cancer patients (including nasopharyngeal cancer)
- Age equals or more than 20 years old
- Referred by Chang Gung Memorial Hospital (CGMH) Head and Neck Oncology team.
- Willing to sign the informed consent
Who cannot join
- Patient who is pregnant or lactating;
- Patients with a concomitant or previous 2nd primary cancer other than head and neck malignancy;
- Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears), poor blood sugar control (fasting sugar more than 200 mg/dl), claustrophobia, unable to lie still.
- Unable to give informed consent
About this study
Official title: Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients
- Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients.
- Secondary endpoint(s): To expand the safety database of [F-18]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis.
Read the detailed description
This is an uncontrolled, open-labeled, non-randomized, prospective study. The study duration is expected to be completed in a period of 3 year. Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified. Each participant must fulfill all the inclusion and exclusion criteria.
- Conditions
- Head and Neck Neoplasms
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Group (a) [Those to undergo surgical excision or biopsy] patients will receive RGD-K5 scan within two weeks of conventional image evaluations. The image result will be confirmed with histopathological results. | |
| Chemotherapy concurrent Radiation | Group (b) patients [Those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy] will receive RGD-K5 scan prior to beginning of the therapy, after induction chemotherapy, within two weeks after concurrent chemoradiotherapy and two months after completion of concurrent chemoradiotherpy; all within two weeks of conventional image evaluations. | |
| RGD-K5 scan | Group (c) patients [Those with M1 disease to receive biotherapy or chemotherapy] will receive RGD-K5 scan prior to the beginning of the first line systemic therapy, two weeks after beginning of the first line systemic therapy, within two weeks of first response evaluation for the first line systemic therapy, and within two weeks after end of the first line systemic therapy; each RGD-K5 scan would be performed within two weeks of conventional image studies. The systemic therapy might be biotherapy or chemotherapy. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzu-Chen Yen, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447134
- Sponsor's protocol ID
- IRB99-3338A
- Status last verified
- Oct 2011
- First submitted
- 4 Oct 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT01447134
- Acronym / sponsor ID
- IRB99-3338A
- Conditions
- Head and Neck Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 6 Oct 2011 (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.
- Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients.
- Secondary endpoint(s): To expand the safety database of [F-18]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis.
Detailed description
This is an uncontrolled, open-labeled, non-randomized, prospective study. The study duration is expected to be completed in a period of 3 year. Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified. Each participant must fulfill all the inclusion and exclusion criteria.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | –Group (a) [Those to undergo surgical excision or biopsy] patients will receive RGD-K5 scan within two weeks of conventional image evaluations. The image result will be confirmed with histopathological results. |
| Chemotherapy concurrent Radiation | – | –Group (b) patients [Those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy] will receive RGD-K5 scan prior to beginning of the therapy, after induction chemotherapy, within two weeks after concurrent chemoradiotherapy and two months after completion of concurrent chemoradiotherpy; all within two weeks of conventional image evaluations. |
| RGD-K5 scan | – | –Group (c) patients [Those with M1 disease to receive biotherapy or chemotherapy] will receive RGD-K5 scan prior to the beginning of the first line systemic therapy, two weeks after beginning of the first line systemic therapy, within two weeks of first response evaluation for the first line systemic therapy, and within two weeks after end of the first line systemic therapy; each RGD-K5 scan would be performed within two weeks of conventional image studies. The systemic therapy might be biotherapy or chemotherapy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified.
Key inclusion criteria (4 listed)
- Head and neck cancer patients (including nasopharyngeal cancer)
- Age equals or more than 20 years old
- Referred by Chang Gung Memorial Hospital (CGMH) Head and Neck Oncology team.
- Willing to sign the informed consent
Key exclusion criteria (4 listed)
- Patient who is pregnant or lactating;
- Patients with a concomitant or previous 2nd primary cancer other than head and neck malignancy;
- Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears), poor blood sugar control (fasting sugar more than 200 mg/dl), claustrophobia, unable to lie still.
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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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?
An observational study of Head and Neck Neoplasms, run by Chang Gung Memorial Hospital.
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 4 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 6 Oct 2011. 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.
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.
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 6 Oct 2011.