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RGD-K5 in Head and Neck Cancer Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Tzu-Chen Yen, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01447134
First received: October 4, 2011
Last updated: October 5, 2011
Last verified: October 2011
  Purpose
  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.

Condition
Head and Neck Neoplasms

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Tzu-Chen Yen, Department of Nuclear Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01447134     History of Changes
Other Study ID Numbers: IRB99-3338A
Study First Received: October 4, 2011
Last Updated: October 5, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 25, 2014