Hypopharyngeal CancerPhase 2NCT01312350
Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
A Phase 2 study testing neoadjuvant docetaxel/cisplatin/fluorouracil and No treatment before definitive CCRT in people with Hypopharyngeal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III \& IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypopharyngeal Cancer
- What is being tested?
- neoadjuvant docetaxel/cisplatin/fluorouracil and No treatment before definitive CCRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically proven stage III/IVM0 hypopharyngeal or base of tongue cancer
- One or more evaluable or measurable lesion
- No prior chemotherapy, radiation, or surgery
- ECOG 0-2
Who cannot join
- Distant metastasis
- Other malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent Chemoradiation Versus Induction Docetaxel, Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy in Locally Advanced Hypopharyngeal and Base of Tongue Cancer: A Randomized Phase II Study
The investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III \& IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone.
- Conditions
- Hypopharyngeal Cancer
- Being tested
- neoadjuvant docetaxel/cisplatin/fluorouracil, No treatment before definitive CCRT
- Keywords
- neoadjuvant chemotherapy, definitive chemoradiation therapy, head and neck cancer, base of tongue, Locally advanced
- Medical subject headings
- Hypopharyngeal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant docetaxel/cisplatin/fluorouracilDrug
Also called Docetaxel (taxotere)
2 cycles of neoadjuvant Docetaxel/cisplatin/5-fluorouracil therapy followed by CCRT Neoadjuvant chemotherapy (docetaxel 75mg/m2 D1, cisplatin 75mg/m2 D1, 5-fluoruracil 759mg/m2/day, D1-4, every 3 weeks) CCRT protocol is same with that of control arm.
No treatment before definitive CCRTDrug
concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43
| Study group | Role | What they receive |
|---|---|---|
| CCRT only arm | Active comparator | no neoadjuvant chemotherapy before definitive CCRT Receives: Drug: No treatment before definitive CCRT |
| neoadjuvant chemotherapy arm | Experimental | 2 cycles of TPF chemotherapy before definitive CCRT Receives: Drug: neoadjuvant docetaxel/cisplatin/fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only
Measured: 18 months after the enrollment of the last patients
Secondary outcomes (3)
To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only
Measured: 18 months after enrollemnt of last patients
To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only
Measured: 18 months after the enrollment of the last patient
To determine whether addition of neoadjuvant chemotherapy to CCRT increase the number of patients with adverse events compared with CCRT only
Measured: 18 months after the enrollment of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionMar 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Samsung 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keunchil Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312350
- Sponsor's protocol ID
- 2010-10-028
- Status last verified
- Dec 2019
- First submitted
- 21 Feb 2011
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemoradiation Versus Induction Docetaxel, Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy in Locally Advanced Hypopharyngeal and Base of Tongue Cancer: A Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT01312350
- Acronym / sponsor ID
- 2010-10-028
- Conditions
- Hypopharyngeal Cancer
- Keywords
- neoadjuvant chemotherapy, definitive chemoradiation therapy, head and neck cancer, base of tongue, Locally advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Mar 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.
The investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III \& IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCRT only arm | Active comparator | Drug: No treatment before definitive CCRTno neoadjuvant chemotherapy before definitive CCRT |
| neoadjuvant chemotherapy arm | Experimental | Drug: neoadjuvant docetaxel/cisplatin/fluorouracil2 cycles of TPF chemotherapy before definitive CCRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically/cytologically proven stage III/IVM0 hypopharyngeal or base of tongue cancer
- One or more evaluable or measurable lesion
- No prior chemotherapy, radiation, or surgery
- ECOG 0-2
Key exclusion criteria (2 listed)
- Distant metastasis
- Other malignancy
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 |
|---|---|---|
| neoadjuvant docetaxel/cisplatin/fluorouracilAlso: Docetaxel (taxotere)2 cycles of neoadjuvant Docetaxel/cisplatin/5-fluorouracil therapy followed by CCRT Neoadjuvant chemotherapy (docetaxel 75mg/m2 D1, cisplatin 75mg/m2 D1, 5-fluoruracil 759mg/m2/day, D1-4, every 3 weeks) CCRT protocol is same with that of control arm. | Drug | neoadjuvant chemotherapy arm |
| No treatment before definitive CCRTconcurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43 | Drug | CCRT only arm |
Primary outcome
To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only
Time frame: 18 months after the enrollment of the last patients
3 secondary outcomes
To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only
Time frame: 18 months after enrollemnt of last patients
To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only
Time frame: 18 months after the enrollment of the last patient
To determine whether addition of neoadjuvant chemotherapy to CCRT increase the number of patients with adverse events compared with CCRT only
Time frame: 18 months after the enrollment of the last patient
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 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
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 neoadjuvant docetaxel/cisplatin/fluorouracil and No treatment before definitive CCRT in people with Hypopharyngeal Cancer, run by Samsung 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 4 inclusion and 2 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 Dec 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.
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?
To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only (time frame: 18 months after the enrollment of the last patients). 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 Dec 2019.