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

NCT02753140 | Unknown Phase 2

• 1 other identifier: YangZZ-2016
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carcinoma, Squamous Cell of Head and Neck

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  13 months

• incidence of oral mucositis

  3 months

Secondary Outcomes (2)

• Overall survival

  5 years

• Overall response rate after induction chemotherapy

  1 month

Study Arms (2)

RT concurrent with cetuximab

EXPERIMENTAL

Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.To observe the curative effect of the treatment of the cetuximab

Drug: Cetuximab; Radiation: radiation

RT concurrent with TP

EXPERIMENTAL

Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy. To observe the curative effect of concurrent radiotherapy and chemotherapy

Radiation: radiation; Drug: Docetaxel; Drug: Cisplatin

Interventions

Cetuximab DRUG

RT concurrent with cetuximab

radiation RADIATION

RT concurrent with TP; RT concurrent with cetuximab

Docetaxel DRUG

RT concurrent with TP

Cisplatin DRUG

RT concurrent with TP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed first diagnosis of locally advanced squamous cell carcinoma of the head and neck
• Imaging (MRI, CT, bone scan) stage Ⅲ、Ⅳa (T1-2N2M0、T3N0-2M0、T4N0-2M0) (2010AJCC staging criteria)
• years of age or older
• Presence of at least 1 measurable lesion according to RECIST version1.1
• DON'T accept surgery, chemotherapy or irradiation before trial entry
• Eastern Cooperative Oncology Group(ECOG) 0 or 1
• Expected survival period over 6months
• 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%;
• Signed written informed consent before any trail-related activities are carried out.

You may not qualify if:

• Patients accepted chemotherapy、radiotherapy or surgery;
• Distant metastasis before trail entry
• Female subjects who are pregnant or breast feeding;
• oral mucositis or oral mucositis has repeatedly made (1 times / month or more)before Chemotherapy or radiotherapy ;
• With teeth periodontitis;
• Any investigational medication within 30 days before trial entry;
• Elderly patients with dry stomatitis;
• 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;
• 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;
• On gastrointestinal physiology is not perfect, or absorb the obstacle syndrome, or unable to tolerate oral medication, or active peptic ulcer；
• Past or current history of neoplasm oher than squamous cell carcinoma of the head and neck;
• 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;
• known human immunodeficiency virus (HIV) infection;
• With immunodeficiency disease, or suffer from other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
• Any disease, metabolic disorders, or physical examination or laboratory suspicion or treatment of complications in patients at high risk of drug.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab; Radiation; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Physical Phenomena; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Zhenzhou Yang, Doctor

CONTACT

+86-13883270881; yangzz1970@163.com

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: Director

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 27, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 27, 2016

Record last verified: 2016-04