Concurrent Chemoradiotherapy(CRT) in Locally Advanced(LA) SCCHN vs Cetuximab With Radiotherapy (RT) After Neoadjuvant Chemotherapy

Carcinoma, Squamous Cell of Head and Neck Clinical Trial

Official title:

Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck Versus Concomitant Cetuximab With Radiotherapy After Neoadjuvant Chemotherapy: a Randomized, Opened, Multicenter Phase II Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02753140
• Other study ID #: YangZZ-2016
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 18, 2016
• Last updated: April 24, 2016
• Start date: April 2016
• Est. completion date: September 2018

Study information

• Verified date: April 2016
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Zhenzhou Yang, Doctor
• Phone: +86-13883270881
• Email: yangzz1970[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Verify the effect and the incidence of oral mucositis of concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.

The predictive effect of Apurinic/apyrimidinic endonuclease 1(APE1)/ Ref-1 protein and Apurinic/apyrimidinic endonuclease 1(APE1)/Ref-1 antibody on oral mucositis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed first diagnosis of locally advanced squamous cell carcinoma of the head and neck

2. Imaging (MRI, CT, bone scan) stage ???a (T1-2N2M0?T3N0-2M0?T4N0-2M0) (2010AJCC staging criteria)

3. 18 years of age or older

4. Presence of at least 1 measurable lesion according to RECIST version1.1

5. DON'T accept surgery, chemotherapy or irradiation before trial entry

6. Eastern Cooperative Oncology Group(ECOG) 0 or 1

7. Expected survival period over 6months

8. Before RT randomization, bone marrow and liver and kidney function in patients with meet the following criteria:

• Hemoglobin(HB) = 100g/L, neutrophil = 2.0 × 109/L and platelet = 100 × 109/L

• Total bilirubin = 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 1.5 times the upper limit of normal;

• More than 1.5 times the upper limit of normal serum creatinine or creatinine clearance rate = 60 ml/min, urea N = 200mg/L;

• The blood glucose level: good blood glucose control, fasting glucose, 3.9-7.2mmol/L postprandial blood glucose less than 10.0mmol/L, HbA1c < 7%;

9. Signed written informed consent before any trail-related activities are carried out.

Exclusion Criteria:

1. Patients accepted chemotherapy?radiotherapy or surgery;

2. Distant metastasis before trail entry

3. Female subjects who are pregnant or breast feeding;

4. oral mucositis or oral mucositis has repeatedly made (1 times / month or more)before Chemotherapy or radiotherapy ;

5. With teeth periodontitis;

6. Any investigational medication within 30 days before trial entry;

7. Elderly patients with dry stomatitis;

8. Any unstable system diseases: including active infection, uncontrolled hypertension, unstable angina pectoris, within the last 3 months of the onset of angina, congestive heart failure, the group in June before the myocardial infarction, need serious mental disorder drug treatment, liver, kidney or metabolic diseases; mental / spiritual diseases such as Alzheimer's disease;

9. Total bilirubin > 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 times the upper limit of normal;

10. On gastrointestinal physiology is not perfect, or absorb the obstacle syndrome, or unable to tolerate oral medication, or active peptic ulcer;

11. Past or current history of neoplasm oher than squamous cell carcinoma of the head and neck;

12. Judgment according to the researchers, there are serious harm to patient safety or affect the patients completed the study with the disease, and patient compliance with the difference;

13. known human immunodeficiency virus (HIV) infection;

14. With immunodeficiency disease, or suffer from other acquired, congenital immunodeficiency disease, or a history of organ transplantation;

15. Any disease, metabolic disorders, or physical examination or laboratory suspicion or treatment of complications in patients at high risk of drug.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Carcinoma, Squamous Cell of Head and Neck
• Head and Neck Neoplasms

Intervention

Drug:
• Cetuximab

Radiation:
• radiation

Drug:
• Docetaxel

• Cisplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		13 months	No
Primary	incidence of oral mucositis		3 months	Yes
Secondary	Overall survival		5 years	No
Secondary	Overall response rate after induction chemotherapy		1 month	No