Organ PreservationFOPSNCT01330056
Functional Organ Preservation Surgery
A study testing FOPS and CRT in people with Organ Preservation, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This is a prospective randomized controlled trial comparing functional organ preservation surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and hypopharynx. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Organ Preservation
- What is being tested?
- FOPS and CRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Dec 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with squamous cell carcinomas arising in the oropharynx, larynx, or hypopharynx
- Resectable tumors without distant metastases
- age range: 18-80 years
- Pretreatment Karnofsky performance scale > or 70%
- Operable patients
- No significant loss of pretreatment larynx and pharyngeal functions
Who cannot join
- Patients with a present or previous history of other cancers except benign tumors, premalignant lesions, carcinoma-in-situ (at some organ sites), well-differentiated thyroid carcinoma and low-grade salivary gland cancers (from tumor-board decision whether the tumors significantly affect the survival outcomes)
- Other organ-site cancers
- Low-performance status or non-operable patients
- Non-resectable or distant-metastatic tumors
- Extensive primary or neck nodal diseases
- Significant pretreament loss of laryngeal or pharyngeal functions
- cT1N0 glottic carcinomas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma
This is a prospective randomized controlled trial comparing functional organ preservation surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and hypopharynx. This study has a hypothesis that the FOPS is an effective treatment strategy to preserve the organ function without compromising oncologic safety and survival.
Read the detailed description
This prospective study compare the following items between two groups:
- Functional outcomes: laryngeal, pharyngeal, and quality of life
- Oncological outcomes: survivals, locoregional controls
- Combined imaging and molecular biomarkers with follow-up data
The functional organ preservation surgery (FOPS) is defined as a surgery preserving the laryngeal or pharyngeal function regardless of open or transoral route. The FOPS may include:
- Radical tonsillectomy or other oropharyngeal resection
- Partial laryngectomy or pharyngectomy
- Transoral laser microresection
- Transoral robotic surgery (TORS)
- Reconstructive surgery may be combined with primary resection
- Neck dissection may be indicated in some patients
- Postoperative radiotherapy or chemoradiotherapy may be indicated in some patients according to their pathologic reports.
The standard concurrent chemoradiotherapy (CRT) is generally used but radiotherapy (RT) alone may be indicated for some patients under tumor-board discussion. The salvage surgery may be indicated for patients with residual or recurrent diseases after CRT or RT.
- Conditions
- Organ Preservation
- Being tested
- FOPS, CRT
- Keywords
- Laryngeal and pharyngeal preservation, survivals
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOPSProcedure or surgery
- Functional organ preservation (FOPS) as a first-line treatment modality
- Postoperative RT or CRT may be included for the patients of this group.
CRTRadiation
- Concurrent chemoradiotherapy as a first-line treatment modality
- Salvage surgery may be applied for the patients with persistent or recurrent cancers after RT or CRT
| Study group | Role | What they receive |
|---|---|---|
| FOPS | Active comparator | * Functional organ preservation surgery (FOPS) group as a first-line treatment modality
* Postoperative RT or CRT may be included for the patients of this group Receives: Procedure: FOPS |
| CRT | Active comparator | * Concurrent chemoradiotherapy or radiotherapy group as a first-line treatment modality
* Salvage surgery may be applied for the patients for persistent or recurrent cancers after CRT or RT Receives: Radiation: CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ preservation rate
The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years.
Measured: 2 years
Secondary outcomes (2)
Survival rate
The time frame may be extended to 5 years.
Measured: 2 years
Locoregional control rate
The time frame may be extended to 5 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ PreservationStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Lyel Roh, Asan Medical Center
- Investigators
- Jong-Lyel Roh, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330056
- Sponsor's protocol ID
- 2010-001
- Acronym
- FOPS
- Status last verified
- Jul 2019
- First submitted
- 4 Apr 2011
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01330056
- Acronym / sponsor ID
- FOPS / 2010-001
- Conditions
- Organ Preservation
- Keywords
- Laryngeal and pharyngeal preservation, survivals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Apr 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.
This is a prospective randomized controlled trial comparing functional organ preservation surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and hypopharynx. This study has a hypothesis that the FOPS is an effective treatment strategy to preserve the organ function without compromising oncologic safety and survival.
Detailed description
This prospective study compare the following items between two groups:
- Functional outcomes: laryngeal, pharyngeal, and quality of life
- Oncological outcomes: survivals, locoregional controls
- Combined imaging and molecular biomarkers with follow-up data
The functional organ preservation surgery (FOPS) is defined as a surgery preserving the laryngeal or pharyngeal function regardless of open or transoral route. The FOPS may include:
- Radical tonsillectomy or other oropharyngeal resection
- Partial laryngectomy or pharyngectomy
- Transoral laser microresection
- Transoral robotic surgery (TORS)
- Reconstructive surgery may be combined with primary resection
- Neck dissection may be indicated in some patients
- Postoperative radiotherapy or chemoradiotherapy may be indicated in some patients according to their pathologic reports.
The standard concurrent chemoradiotherapy (CRT) is generally used but radiotherapy (RT) alone may be indicated for some patients under tumor-board discussion. The salvage surgery may be indicated for patients with residual or recurrent diseases after CRT or RT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOPS | Active comparator | Procedure: FOPS* Functional organ preservation surgery (FOPS) group as a first-line treatment modality * Postoperative RT or CRT may be included for the patients of this group |
| CRT | Active comparator | Radiation: CRT* Concurrent chemoradiotherapy or radiotherapy group as a first-line treatment modality * Salvage surgery may be applied for the patients for persistent or recurrent cancers after CRT or RT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with squamous cell carcinomas arising in the oropharynx, larynx, or hypopharynx
- Resectable tumors without distant metastases
- age range: 18-80 years
- Pretreatment Karnofsky performance scale > or 70%
- Operable patients
Key exclusion criteria (7 listed)
- Patients with a present or previous history of other cancers except benign tumors, premalignant lesions, carcinoma-in-situ (at some organ sites), well-differentiated thyroid carcinoma and low-grade salivary gland cancers (from tumor-board decision whether the tumors significantly affect the survival outcomes)
- Other organ-site cancers
- Low-performance status or non-operable patients
- Non-resectable or distant-metastatic tumors
- Extensive primary or neck nodal diseases
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 |
|---|---|---|
| FOPS* Functional organ preservation (FOPS) as a first-line treatment modality * Postoperative RT or CRT may be included for the patients of this group. | Procedure or surgery | FOPS |
| CRT* Concurrent chemoradiotherapy as a first-line treatment modality * Salvage surgery may be applied for the patients with persistent or recurrent cancers after RT or CRT | Radiation | CRT |
Primary outcome
Organ preservation rate
Time frame: 2 years
The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years.
2 secondary outcomes
Survival rate
Time frame: 2 years
Locoregional control rate
Time frame: 2 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 9 Jul 2019.
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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.
Jong-Lyel Roh, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOPS and CRT in people with Organ Preservation, run by Asan Medical Center at 1 site in South Korea.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jul 2019. 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 South Korea. 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 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?
Organ preservation rate (time frame: 2 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 9 Jul 2019.