Hypopharyngeal CancerPhase 2NCT03558035
New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
A Phase 2 study testing Induction CT+ CRT group and Concurrent CRT group in people with Hypopharyngeal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypopharyngeal Cancer
- What is being tested?
- Induction CT+ CRT group and Concurrent CRT group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Mar 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven squamous cell carcinoma of hypopharynx
- Stage III/IV M0, with T3/4 N0-3 or T1-4 N2-3
- Karnofsky Performance Status>=70
- Have measurable lesions on CT/MRI
- Treatment for the first time
- Expected lifetime > 6 months
Show all 10Show fewer
- Normal blood test, hepatic and renal functions
- Normal hearing
- Can understand and sign the consent
- Have follow up condition
Who cannot join
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Previously treatment for cancer
- Pregnant or breeding woman, female without contraception
- Enrolling in other drug trials
- Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
- Without follow up
- Receive target therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Junlin YI, MD, 861087788504, junlinyi@sohu.com
About this study
To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.
Read the detailed description
Eligiblity patient were assign to induction chemotherapy plus concurrent chemotherapy group (IC +CCRT group, Arm A)and concurrent chemoradiotherapy group(CCRT group, Arm B). For patients in Arm A, treatment response were evaluated after 2cycles, if the response reached partial response/complete response, patients received concurrent chemoradiotherapy, otherwise, patients will received surgery and radiotherpay/concurrent chemoradiotherapy after surgery. For patients received concurrent chemoradiotherapy (both in Arm A and Arm B) , treatment response were evaluated at 50 Gy. if response reached complete response or major partial response(>80% tumor regression), patients will received radical chemoradiotherapy, otherwise, patients will received surgery.
- Conditions
- Hypopharyngeal Cancer
- Being tested
- Induction CT+ CRT group, Concurrent CRT group
- Keywords
- Hypopharyngeal carcinoma, Locally advanced, Multi-disciplinary treatment, Functional Magnetic Resonance Imaging, Prognosis
- Medical subject headings
- Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction CT+ CRT groupDrug
Induction CT: Paclitaxel 175mg/m2 IV on d1 and d22, cisplatin 75mg/m2 IV on d1 and d22, 5-Fluorouracil 750mg/m2 IV continuously on d1-4 and d22-25, CRT: cisplatin 80mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
Concurrent CRT groupRadiation
cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Induction chemotherapy and concurret chemoradiotherapy group | Experimental | Patients receive 2 cycles of paclitaxel, cisplatin and 5-Fluorouracil chemotherapy followed by Surgery or Chemo-radiotherapy according to the response status after induction chemo. Receives: Drug: Induction CT+ CRT group |
| Concurrent chemoradiotherapy group | Active comparator | Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy Receives: Radiation: Concurrent CRT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 year
Secondary outcomes (4)
disease free survival
Measured: 5 year
distant-metastasis free survival
Measured: 5 year
larynx-preservation rate
Measured: 5 year
treatment related toxicities
hematology and surgery related complications
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study startSep 2014
- Primary completionFeb 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypopharyngeal CancerStudies of the same condition, open and under way.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Lin Yi, MD, Chinese Academy of Medical Sciences
- Investigators
- Junlin Yi, Professor, Principal investigator, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558035
- Sponsor's protocol ID
- LC2014L12
- Status last verified
- Jan 2021
- First submitted
- 5 Jun 2018
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blanchard P, Baujat B, Holostenco V, Bourredjem A, Baey C, Bourhis J, Pignon JP; MACH-CH Collaborative group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol. 2011 Jul;100(1):33-40. doi: 10.1016/j.radonc.2011.05.036. Epub 2011 Jun 16.
PubMed 21684027Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP; Meta-Analysis of Chemotherapy in Head and Neck Cancer, Induction Project, Collaborative Group. Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol. 2013 Aug 10;31(23):2854-60. doi: 10.1200/JCO.2012.47.7802. Epub 2013 Jul 8.
PubMed 23835714Pointreau Y, Garaud P, Chapet S, Sire C, Tuchais C, Tortochaux J, Faivre S, Guerrif S, Alfonsi M, Calais G. Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation. J Natl Cancer Inst. 2009 Apr 1;101(7):498-506. doi: 10.1093/jnci/djp007. Epub 2009 Mar 24.
PubMed 19318632Luo X, Huang X, Luo J, Xiao J, Wang K, Qu Y, Chen X, Zhang Y, Wu R, Wang J, Zhang J, Xu G, Gao L, Liu S, Wang X, He X, Luo D, Yi J. Induction TPF followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locally advanced hypopharyngeal cancer: a preliminary analysis of a randomized phase 2 trial. BMC Cancer. 2022 Nov 29;22(1):1235. doi: 10.1186/s12885-022-10306-y.
PubMed 36447152
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03558035
- Acronym / sponsor ID
- LC2014L12
- Conditions
- Hypopharyngeal Cancer
- Keywords
- Hypopharyngeal carcinoma, Locally advanced, Multi-disciplinary treatment, Functional Magnetic Resonance Imaging, Prognosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 15 Jun 2018 (actual)
- 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.
To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.
Detailed description
Eligiblity patient were assign to induction chemotherapy plus concurrent chemotherapy group (IC +CCRT group, Arm A)and concurrent chemoradiotherapy group(CCRT group, Arm B). For patients in Arm A, treatment response were evaluated after 2cycles, if the response reached partial response/complete response, patients received concurrent chemoradiotherapy, otherwise, patients will received surgery and radiotherpay/concurrent chemoradiotherapy after surgery. For patients received concurrent chemoradiotherapy (both in Arm A and Arm B) , treatment response were evaluated at 50 Gy. if response reached complete response or major partial response(>80% tumor regression), patients will received radical chemoradiotherapy, otherwise, patients will received surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction chemotherapy and concurret chemoradiotherapy group | Experimental | Drug: Induction CT+ CRT groupPatients receive 2 cycles of paclitaxel, cisplatin and 5-Fluorouracil chemotherapy followed by Surgery or Chemo-radiotherapy according to the response status after induction chemo. |
| Concurrent chemoradiotherapy group | Active comparator | Radiation: Concurrent CRT groupPatients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven squamous cell carcinoma of hypopharynx
- Stage III/IV M0, with T3/4 N0-3 or T1-4 N2-3
- Karnofsky Performance Status>=70
- Have measurable lesions on CT/MRI
- Treatment for the first time
Key exclusion criteria (7 listed)
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Previously treatment for cancer
- Pregnant or breeding woman, female without contraception
- Enrolling in other drug trials
- Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
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 |
|---|---|---|
| Induction CT+ CRT groupInduction CT: Paclitaxel 175mg/m2 IV on d1 and d22, cisplatin 75mg/m2 IV on d1 and d22, 5-Fluorouracil 750mg/m2 IV continuously on d1-4 and d22-25, CRT: cisplatin 80mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy | Drug | Induction chemotherapy and concurret chemoradiotherapy group |
| Concurrent CRT groupcisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy | Radiation | Concurrent chemoradiotherapy group |
Primary outcome
overall survival
Time frame: 5 year
4 secondary outcomes
disease free survival
Time frame: 5 year
distant-metastasis free survival
Time frame: 5 year
larynx-preservation rate
Time frame: 5 year
treatment related toxicities
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Background: PubMed 21684027Blanchard P, Baujat B, Holostenco V, Bourredjem A, Baey C, Bourhis J, Pignon JP; MACH-CH Collaborative group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol. 2011 Jul;100(1):33-40. doi: 10.1016/j.radonc.2011.05.036. Epub 2011 Jun 16.
- Background: PubMed 23835714Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP; Meta-Analysis of Chemotherapy in Head and Neck Cancer, Induction Project, Collaborative Group. Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol. 2013 Aug 10;31(23):2854-60. doi: 10.1200/JCO.2012.47.7802. Epub 2013 Jul 8.
- Background: PubMed 19318632Pointreau Y, Garaud P, Chapet S, Sire C, Tuchais C, Tortochaux J, Faivre S, Guerrif S, Alfonsi M, Calais G. Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation. J Natl Cancer Inst. 2009 Apr 1;101(7):498-506. doi: 10.1093/jnci/djp007. Epub 2009 Mar 24.
- Derived from this study: PubMed 36447152Luo X, Huang X, Luo J, Xiao J, Wang K, Qu Y, Chen X, Zhang Y, Wu R, Wang J, Zhang J, Xu G, Gao L, Liu S, Wang X, He X, Luo D, Yi J. Induction TPF followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locally advanced hypopharyngeal cancer: a preliminary analysis of a randomized phase 2 trial. BMC Cancer. 2022 Nov 29;22(1):1235. doi: 10.1186/s12885-022-10306-y.
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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.
Junlin Yi, Professor principal investigator
CAMS
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 Induction CT+ CRT group and Concurrent CRT group in people with Hypopharyngeal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
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 10 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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junlin Yi, Professor (0086013661217998, yijunlin1969@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 year). 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 NCT03558035, which also lists 4 linked publications.
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 2021.