New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
1 other identifier
interventional
96
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2014
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 5, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJanuary 29, 2021
January 1, 2021
6.4 years
June 5, 2018
January 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
5 year
Secondary Outcomes (4)
disease free survival
5 year
distant-metastasis free survival
5 year
larynx-preservation rate
5 year
treatment related toxicities
2 year
Study Arms (2)
Induction chemotherapy and concurret chemoradiotherapy group
EXPERIMENTALPatients 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 COMPARATORPatients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy
Interventions
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
cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
Eligibility Criteria
You may qualify if:
- 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
- Normal blood test, hepatic and renal functions
- Normal hearing
- Can understand and sign the consent
- Have follow up condition
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
Related Publications (4)
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.
PMID: 21684027BACKGROUNDBlanchard 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.
PMID: 23835714BACKGROUNDPointreau 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.
PMID: 19318632BACKGROUNDLuo 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.
PMID: 36447152DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junlin Yi, Professor
CAMS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 5, 2018
First Posted
June 15, 2018
Study Start
September 1, 2014
Primary Completion
February 1, 2021
Study Completion
March 1, 2021
Last Updated
January 29, 2021
Record last verified: 2021-01