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

• ClinicalTrials.gov Identifier: NCT03117257
• Recruitment Status: Unknown
• First Posted: April 17, 2017
• Last Update Posted: April 17, 2017
• Sponsor: Guiyang Medical University
• Information provided by (Responsible Party): Feng Jing, Guiyang Medical University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Locally Advanced Head and Neck Squamous Cell Carcinoma	Drug: Lobaplatin; Drug: Cisplatin	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 19, 2016
• Estimated Primary Completion Date: August 19, 2019
• Estimated Study Completion Date: August 20, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: the treatment group; docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy	Drug: Lobaplatin; Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy; Other Name: Platinum
Active Comparator: the control group; TPF induction chemotherapy combined with cisplatin chemoradiotherapy	Drug: Cisplatin; Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy; Other Name: cis-DDP; cis-Diammineplatinum(II) dichloride;

Outcome Measures

Primary Outcome Measures :

1. National Cancer Institute CTCAE v4.0 [ Time Frame: 1 year ]
   Acute toxicity of radiotherapy and chemotherapy
2. evaluation of immediate efficacy [ Time Frame: 1 year ]
   Evaluation of efficacy by RESIST1.1 standard

Secondary Outcome Measures :

1. overall survival [ Time Frame: 5 years ]
   Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.
2. progression-free survival [ Time Frame: 5 years ]
   Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 Ⅲ - ⅣA, ⅣB period.

   After surgery: 2010UICC staging ⅣA, ⅣB;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

Contacts and Locations

Contacts

Contact: Feng Jin, Bachelor; 86-851-86512802; jinf8865@yeah.net

Contact: Weili Wu, master; 86-13885124077; wwlmhy@163.com

Locations

China, Guizhou

Cancer Hospital of Guizhou Medical University; Recruiting

Guiyang, Guizhou, China, 550000

Contact: Feng Jin, Bachelor 0851-86512802 jinf8865@yahoo.com.cn

Sub-Investigator: Weili Wu, master

Sub-Investigator: Jinhua Long, master

Sub-Investigator: Yuanyuan Li, master

Sub-Investigator: Xiuyun Gong, Bachelor

Sub-Investigator: Xiaoxiao Chen, Bachelor

Sub-Investigator: Mang Zhang, Bachelor

Sponsors and Collaborators

Guiyang Medical University

Investigators

• Study Chair: Feng Jin, Bachelor; Guizhou Provincial Cancer Hospital

More Information

• Responsible Party: Feng Jing, Head and neck cancer director, chief researcher, clinical professor, Guiyang Medical University
• ClinicalTrials.gov Identifier: NCT03117257
• Other Study ID Numbers: 20160819
• First Posted: April 17, 2017
• Last Update Posted: April 17, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Feng Jing, Guiyang Medical University:

Lobaplatin; head and neck cancer; chronic-chemotherapy

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site; Cisplatin; Antineoplastic Agents