Esophageal CancerPhase 2NCT00002951
Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
A Phase 2 study testing fluorouracil, hydroxyurea and surgical procedure in people with Esophageal Cancer and Head and Neck Cancer, run by University of Chicago at 4 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer, Head and Neck Cancer
- What is being tested?
- fluorouracil, hydroxyurea and surgical procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 1996to Jul 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed diagnosis of carcinoma
- Stage II-III (T2, T3, N0 or T1-3, N1) carcinoma of head and neck, including: oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus
- No N2 or N3
- Measurable disease is not required
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-3
Life expectancy:
- Anticipated survival is 3-4 years (median)
Hematopoietic:
- WBC count at least 3.5/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- Not specified
Pulmonary:
- Not specified
Other:
- No infection or severe medical illness
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- No prior surgery
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
CCOP - Evanston
Evanston, Illinois, 60201
About this study
Official title: Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer.
Read the detailed description
OBJECTIVES:
- Determine the locoregional control rates, time to failure, need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus.
- Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation, organ function and quality of life parameters.
- Identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring.
OUTLINE: Patients receive concomitant chemoradiotherapy with curative intent. Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure.
The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5. Fluorouracil is given IV on days 0-4. Radiation therapy BID is given on days 1-6. Cycles repeat every 14 days for a total of 5 cycles.
The disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months for 1 year, then yearly.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
- Conditions
- Esophageal Cancer, Head and Neck Cancer
- Being tested
- fluorouracil, hydroxyurea, surgical procedure, radiation therapy
- Keywords
- stage II esophageal cancer, stage III esophageal cancer, stage II nasopharyngeal cancer, stage III nasopharyngeal cancer, stage II lip and oral cavity cancer, stage III lip and oral cavity cancer, stage II hypopharyngeal cancer, stage III hypopharyngeal cancer, stage II laryngeal cancer, stage III laryngeal cancer, stage II paranasal sinus and nasal cavity cancer, stage III paranasal sinus and nasal cavity cancer, stage II oropharyngeal cancer, stage III oropharyngeal cancer
- Medical subject headings
- Esophageal Neoplasms, Head and Neck Neoplasms, Nasopharyngeal Neoplasms, Mouth Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
hydroxyureaDrug
surgical procedureProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Hyper-FHX) | Experimental | Concomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles) Receives: Drug: fluorouracil; Drug: hydroxyurea; Procedure: surgical procedure; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control rate
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 1996
- Primary completionJun 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Everett E. Vokes, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002951
- Sponsor's protocol ID
- 8176
- Other IDs
- UCCRC-8176, NU-V96N1, NCI-G97-1159
- Status last verified
- Sep 2013
- First submitted
- 1 Nov 1999
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen EE, Haraf DJ, List MA, Kocherginsky M, Mittal BB, Rosen F, Brockstein B, Williams R, Witt ME, Stenson KM, Kies MS, Vokes EE. High survival and organ function rates after primary chemoradiotherapy for intermediate-stage squamous cell carcinoma of the head and neck treated in a multicenter phase II trial. J Clin Oncol. 2006 Jul 20;24(21):3438-44. doi: 10.1200/JCO.2006.05.8529.
PubMed 16849759
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck
- ClinicalTrials.gov ID
- NCT00002951
- Acronym / sponsor ID
- 8176
- Conditions
- Esophageal Cancer, Head and Neck Cancer
- Keywords
- stage II esophageal cancer, stage III esophageal cancer, stage II nasopharyngeal cancer, stage III nasopharyngeal cancer, stage II lip and oral cavity cancer, stage III lip and oral cavity cancer, stage II hypopharyngeal cancer, stage III hypopharyngeal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 1996
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer.
Detailed description
OBJECTIVES:
- Determine the locoregional control rates, time to failure, need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus.
- Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation, organ function and quality of life parameters.
- Identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring.
OUTLINE: Patients receive concomitant chemoradiotherapy with curative intent. Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure.
The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5. Fluorouracil is given IV on days 0-4. Radiation therapy BID is given on days 1-6. Cycles repeat every 14 days for a total of 5 cycles.
The disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months for 1 year, then yearly.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A (Hyper-FHX) | Experimental | Drug: fluorouracil, Drug: hydroxyurea, Procedure: surgical procedure, Radiation: radiation therapyConcomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| fluorouracil | Drug | Arm A (Hyper-FHX) |
| hydroxyurea | Drug | Arm A (Hyper-FHX) |
| surgical procedure | Procedure or surgery | Arm A (Hyper-FHX) |
| radiation therapy | Radiation | Arm A (Hyper-FHX) |
Primary outcome
Locoregional control rate
Time frame: 8 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 5 Sep 2013.
- Results publication: PubMed 16849759Cohen EE, Haraf DJ, List MA, Kocherginsky M, Mittal BB, Rosen F, Brockstein B, Williams R, Witt ME, Stenson KM, Kies MS, Vokes EE. High survival and organ function rates after primary chemoradiotherapy for intermediate-stage squamous cell carcinoma of the head and neck treated in a multicenter phase II trial. J Clin Oncol. 2006 Jul 20;24(21):3438-44. doi: 10.1200/JCO.2006.05.8529.
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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 E. Vokes, MD study chair
University of Chicago
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluorouracil, hydroxyurea and surgical procedure in people with Esophageal Cancer and Head and Neck Cancer, run by University of Chicago at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Locoregional control rate (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002951, which also lists 1 linked publication.
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 5 Sep 2013.