Clinical trial · Interventional
New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma
NCT03558035CI-TRIAL-00049712unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypopharyngeal Cancer | Malignant Hypopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent CRT group | Radiation | — | UNRESOLVED |
| Induction CT+ CRT group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Induction chemotherapy and concurret chemoradiotherapy group
- description
- 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.
- interventionNames
- Drug: Induction CT+ CRT group
- type
- ACTIVE_COMPARATOR
- label
- Concurrent chemoradiotherapy group
- description
- Patients receive single-agent cisplatin chemotherapy concurrent with Radiotherapy
- interventionNames
- Radiation: Concurrent CRT group
Primary outcomes (1)
- measure
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (4)
- BACKGROUNDBlanchard 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 21684027
- BACKGROUNDBlanchard 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 23835714
- BACKGROUNDPointreau 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 19318632
- DERIVEDLuo 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 36447152