Head and NeckPhase 2NCT01693718
A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
A Phase 2 study testing Hydroxyurea, 5- Fluorouracil and Cisplatin in people with Head and Neck, run by University of Chicago at 1 site in United States.
Trial summary
The goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer. Read more about this study
- Who is it for?
- Ages 59 years and older
- Conditions the study is for
- Head and Neck
- What is being tested?
- Hydroxyurea, 5- Fluorouracil and Cisplatin
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Sep 2004
- 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 59 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Eligibility Criteria:
- Patients with Stage IV carcinoma of the nasal or oral cavity, nasopharynx pharynx, larynx, paranasal sinuses, cervical esophagus, or hypopharynx are eligible. Patients with Stage III carcinoma of the nasopharynx, base of tongue and hypopharynx are also eligible. Therapy is given with curative intent. Prior to entry in the study the resectability and standard treatment options for each patient will be determined during a joint evaluation by a team composed of an attending surgeon, a radiation oncologist and a medical oncologist. In addition the timing and feasibility of surgery will be determined in each patient prior to initiation of therapy. The unequivocal demonstration of distant metastasis confers in eligibility.
- Measurable disease is not required, but all disease will be carefully evaluated.
- Patients must have a histologically or cytologically confirmed diagnosis of squamous cell carcinoma or lymphoepithelioma.
- Patients must have not received prior chemotherapy or radiotherapy.
- Patients must have performance status of >60%
- Patients must have a WBC count of >3.5, an ANC count >1500 and a platlet count of >100,000.
- The serum creatinine must be equal to or less than 1.5 m/dlor the calculated creatinine clearance must exceed 50cc/min.
- Patient must be free of significant infection or other severe complicating medical illness.
- Pregnancy will constitute an absolute contraindication to entrance on this protocol. Females of child-bearing age should be using adequate contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
The goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer.
- Conditions
- Head and Neck
- Being tested
- Hydroxyurea, 5- Fluorouracil, Cisplatin
- Keywords
- cancer, advanced, oral cavity, larynx
- Medical subject headings
- Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxyureaDrug
Hydroxyurea at 1gm(PO)12hrs x 11days(2gm/day). The first daily dose of hydroxyurea on days 1-5 is given 2 hrs prior to the first fraction of daily radiotherapy.
5- FluorouracilDrug
Start continuous infusion of 5-Fluorouracil at 800mg/m2/day x 5 days (120 hrs.
Radiation therapy is administered twice daily at 150 cGY per fraction, every other week with chemotherapy.
CisplatinDrug
Cisplatin 100mg/m2 I.V. on the evening of the day 1, on cycles 1,3,and 5 only in 200cc NS IV over 2 h. Ensure adequate hydration to keep urine output > 100 cc/ hour.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rates
To evaluate the activity of 5 cycles of C-FHX/G-CSF in previously untreated patients with stage II and IV locoregionally advanced head and neck cancer.
Measured: 2-5 years
Secondary outcomes (2)
Feasibility of administering adjuvant CRA and interferon alfa2a
To determine the feasibility of administering adjuvant CRA and interferon alfa2a for up to one or until tumor progression in patients completing local therapy.
Measured: 2-5 years
Side effects of study regimen
To determine the pattern and degree of clinical toxicity of this regimen
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startMar 2003
- Primary completionSep 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and NeckStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Everett Vokes, MD, Principal investigator, The University of Chicago Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693718
- Sponsor's protocol ID
- 12141B
- Status last verified
- Jan 2024
- First submitted
- 20 Aug 2010
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01693718
- Acronym / sponsor ID
- 12141B
- Conditions
- Head and Neck
- Keywords
- cancer, advanced, oral cavity, larynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 26 Sep 2012 (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 goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 59 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HydroxyureaHydroxyurea at 1gm(PO)12hrs x 11days(2gm/day). The first daily dose of hydroxyurea on days 1-5 is given 2 hrs prior to the first fraction of daily radiotherapy. | Drug | – |
| 5- FluorouracilStart continuous infusion of 5-Fluorouracil at 800mg/m2/day x 5 days (120 hrs. Radiation therapy is administered twice daily at 150 cGY per fraction, every other week with chemotherapy. | Drug | – |
| CisplatinCisplatin 100mg/m2 I.V. on the evening of the day 1, on cycles 1,3,and 5 only in 200cc NS IV over 2 h. Ensure adequate hydration to keep urine output > 100 cc/ hour. | Drug | – |
Primary outcome
Response Rates
Time frame: 2-5 years
To evaluate the activity of 5 cycles of C-FHX/G-CSF in previously untreated patients with stage II and IV locoregionally advanced head and neck cancer.
2 secondary outcomes
Feasibility of administering adjuvant CRA and interferon alfa2a
Time frame: 2-5 years
Side effects of study regimen
Time frame: 2-5 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 29 Jan 2024.
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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.
Everett Vokes, MD principal investigator
The University of Chicago Medical Center
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 Hydroxyurea, 5- Fluorouracil and Cisplatin in people with Head and Neck, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Jan 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 United States. 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?
Response Rates (time frame: 2-5 years). 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 29 Jan 2024.