Head and Neck NeoplasmsNCT00937612
Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk
A study testing Radiotherapy in people with Head and Neck Neoplasms and Carcinoma, Squamous Cell, run by Chang Gung Memorial Hospital at 3 sites in Taiwan.
Trial summary
The purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesTaiwan
- Study dates
- Jun 2008to Mar 2014
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary squamous cell carcinoma of head and neck, after tumor excision and neck dissection, pathology has confirmed three or more of the following adverse prognostic factors, including:
- Marginale surgery but a safe distance from the residual tumor ≦ 4mm.
- The tumor is located in the hard palate or the retromolar region.
- Poorly differentiated cell type.
- Tumor invasion to the nerve.
- Tumor invasion to lymphatic vessels.
Show all 11Show fewer
- Tumor invasion to the small blood vessels.
- Tumor invasion to the bone.
- Tumor invasion to the skin.
- Depth of tumor invasion ≧ 10mm.
- Occurred in single lymph node metastasis.
Who cannot join
- No or presence of adverse prognostic factor but less than 2.
- Presence of either one conditions listed here: positive resection margin, resection margin negative but less than 1 mm, pathologic N2 or N2, or presence of nodal metastasis with extracapsular spreading.
- ECOG performance status > 2.
- Previous cancer history (except basal cell or squamous cell skin cancer) or other synchronous malignant disease.
- Women during pregnancy.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Chang Gung Memorial Hospital, Keelung branch
Keelung, 222
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, 333
Department of Radiation Therapy, Chang Gung Memorial Hospital, Linkou branch
Taoyuan, 333
About this study
Official title: A Phase II Trial of Postoperative Concurrent Chemoradiation for Head and Neck Squamous Cell Carcinoma Patients With Multiple Risk Factors of Recurrence
The purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.
Read the detailed description
Currently, postoperative chemoradiation is recommended for head and neck squamous cell carcinoma with some poor prognostic feature, such as extracapsular spread of metastatic lymph node, or positive resection margin. Other patients may receive postoperative radiotherapy only, if they have other risk factors. In our previous study, if there are 3 or more "minor" risk factors, the 3-year recurrence rate was 55%. This outcome was far inferior to patients who had minor risk factors less than 3. Thus, we believe that current postoperative radiotherapy is insufficient for patients with multiple minor risks. A clinical trial should be raised to help these patients. However, the patient number of this group is not enough for large scale, phase 3 trial. So we arranged this phase II trial of postoperative chemoradiation to test and prospectively observe the treatment outcome.
- Conditions
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
- Being tested
- Radiotherapy
- Keywords
- Head and Neck Neoplasms, Chemotherapy, Radiotherapy, Adjuvant, Surgery
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called CGHN 3R trial
postoperative radiotherapy, 60-66 Gy/30-33 fractions, concurrently with triweekly chemotherapy by Cisplatin
| Study group | Role | What they receive |
|---|---|---|
| concurrent chemoradiation | Experimental | patients who has 3 or more minor risk factors of recurrence, and will receive postoperative chemoradiation. Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJun 2008
- Primary completionMar 2011
- Study completionMar 2014
Why it stopped: Study group showed better results. Poor Accrual.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang-Hsing Fan, Chang Gung Memorial Hospital
- Investigators
- Kang-Hsing Fan, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937612
- Sponsor's protocol ID
- CGHN-0801
- Status last verified
- Feb 2017
- First submitted
- 9 Jul 2009
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Postoperative Concurrent Chemoradiation for Head and Neck Squamous Cell Carcinoma Patients With Multiple Risk Factors of Recurrence
- ClinicalTrials.gov ID
- NCT00937612
- Acronym / sponsor ID
- CGHN-0801
- Conditions
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
- Keywords
- Head and Neck Neoplasms, Chemotherapy, Radiotherapy, Adjuvant, Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study group showed better results. Poor Accrual.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Jul 2009 (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 purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.
Detailed description
Currently, postoperative chemoradiation is recommended for head and neck squamous cell carcinoma with some poor prognostic feature, such as extracapsular spread of metastatic lymph node, or positive resection margin. Other patients may receive postoperative radiotherapy only, if they have other risk factors. In our previous study, if there are 3 or more "minor" risk factors, the 3-year recurrence rate was 55%. This outcome was far inferior to patients who had minor risk factors less than 3. Thus, we believe that current postoperative radiotherapy is insufficient for patients with multiple minor risks. A clinical trial should be raised to help these patients. However, the patient number of this group is not enough for large scale, phase 3 trial. So we arranged this phase II trial of postoperative chemoradiation to test and prospectively observe the treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| concurrent chemoradiation | Experimental | Radiation: Radiotherapypatients who has 3 or more minor risk factors of recurrence, and will receive postoperative chemoradiation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Primary squamous cell carcinoma of head and neck, after tumor excision and neck dissection, pathology has confirmed three or more of the following adverse prognostic factors, including:
Key exclusion criteria (5 listed)
- No or presence of adverse prognostic factor but less than 2.
- Presence of either one conditions listed here: positive resection margin, resection margin negative but less than 1 mm, pathologic N2 or N2, or presence of nodal metastasis with extracapsular spreading.
- ECOG performance status > 2.
- Previous cancer history (except basal cell or squamous cell skin cancer) or other synchronous malignant disease.
- Women during pregnancy.
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 |
|---|---|---|
| RadiotherapyAlso: CGHN 3R trialpostoperative radiotherapy, 60-66 Gy/30-33 fractions, concurrently with triweekly chemotherapy by Cisplatin | Radiation | concurrent chemoradiation |
Primary outcome
Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.
Time frame: 3 year
Results and safety
The study was stopped early (reason given: Study group showed better results. Poor Accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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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.
Kang-Hsing Fan, MD principal investigator
Chang Gung Memorial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with Head and Neck Neoplasms and Carcinoma, Squamous Cell, run by Chang Gung Memorial Hospital at 3 sites in Taiwan.
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 11 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. 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.
Are results available for this study?
The study was stopped early (reason given: Study group showed better results. Poor Accrual.). 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.
What does the primary outcome measure?
Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended. (time frame: 3 year). 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 8 Feb 2017.