New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma

Hypopharyngeal Cancer Clinical Trial

Official title:

New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03558035
• Other study ID #: LC2014L12
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: March 2021

Study information

• Verified date: January 2021
• Source: Chinese Academy of Medical Sciences
• Contact: Junlin Yi, Professor
• Phone: 0086013661217998
• Email: yijunlin1969[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: March 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Hypopharyngeal Cancer
• Hypopharyngeal Neoplasms

Intervention

Drug:
• Induction CT+ CRT group
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

Radiation:
• Concurrent CRT group
cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy

Locations

Country	Name	City	State
China	Cancer hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

Blanchard 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. — View Citation

Pointreau 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5 year
Secondary	disease free survival		5 year
Secondary	distant-metastasis free survival		5 year
Secondary	larynx-preservation rate		5 year
Secondary	treatment related toxicities	hematology and surgery related complications	2 year