Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced SCCHN

Locally Advanced Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

A Prospective Phase II Randomized Clinical Trial: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Lobaplatin Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03117257
• Other study ID #: 20160819
• Status: Recruiting
• Phase: Phase 2
• First received: April 2, 2017
• Last updated: April 14, 2017
• Start date: August 19, 2016
• Est. completion date: August 20, 2021

Study information

• Verified date: April 2017
• Source: Guiyang Medical University
• Contact: Feng Jin, Bachelor
• Phone: 86-851-86512802
• Email: jinf8865[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma.

Description:

TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin， direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients. Therefore, how to improve the efficacy of the same time to reduce adverse drug reactions, as a prominent problem. Lobaplatin as the third generation of platinum antitumor drugs, anti-cancer activity and cisplatin rather, more than carboplatin. In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: August 20, 2021
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Voluntary participation and written informed consent

2. Age 18-70 years old, gender is not limited

3. histologically proved to be squamous cell carcinoma

4. No surgery: head and neck squamous cell carcinoma 2010UICC staging ? - ?A, ?B period.

After surgery: 2010UICC staging ?A, ?B;stage III tongue base or hypopharyngeal primaries;Postoperative naked eye or image residual stage III patients

5. Karnofsky score =70

6. Survival is expected to be = 6 months

7. Women of childbearing age should be guaranteed contraception during the study period

8. (WBC) =4 × 109 / L * (unit normal), platelet (PLT) =100 × 109 / L (unit normal value), neutrophil cell (WBC), hematocrit (WBC) =1.5 × 109 / L * (unit normal value)

9. liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) <upper limit of normal (ULN) 1.5 times; total bilirubin <1.5 × ULN

10. renal function: serum creatinine <1.5 × ULN, endogenous creatinine clearance rate (Ccr) = 55 ml / min

11. no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history

12. The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months).

Exclusion Criteria:

1. There is a distant shift

2. primary lesions or lymph nodes were radiotherapy

3. had received epidermal growth factor targeted therapy

4. primary tumor had received chemotherapy or immunotherapy

5. had other malignancies (except for cured basal cell carcinoma or cervical cancer)

6. pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age

7. have a serious history of allergies or specific physical

8. Abuse of drugs or alcohol addicts

9. Person who has personality or mental illness, no civil capacity or limited civil capacity

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Locally Advanced Head and Neck Squamous Cell Carcinoma

Intervention

Drug:
• Lobaplatin
Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy
• Cisplatin
Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy

Locations

Country	Name	City	State
China	Cancer Hospital of Guizhou Medical University	Guiyang	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Guiyang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Cancer Institute CTCAE v4.0	Acute toxicity of radiotherapy and chemotherapy	1 year
Primary	evaluation of immediate efficacy	Evaluation of efficacy by RESIST1.1 standard	1 year
Secondary	overall survival	Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.	5 years
Secondary	progression-free survival	Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.	5 years