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

NCT ID: NCT03117257

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-19
• Study Completion Date: 2021-08-20

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.

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.

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

the treatment group

docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy

Group Type: EXPERIMENTAL

Lobaplatin

Intervention Type: DRUG

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

the control group

TPF induction chemotherapy combined with cisplatin chemoradiotherapy

Group Type: ACTIVE_COMPARATOR

Cisplatin

Intervention Type: DRUG

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

Interventions

Lobaplatin

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Other Intervention Names

Platinum; cis-DDP; cis-Diammineplatinum(II) dichloride;

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guiyang Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng Jing

Head and neck cancer director, chief researcher, clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Jin, Bachelor

Role: STUDY_CHAIR

Guizhou Provincial Cancer Hospital

Locations

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Jin, Bachelor

Role: CONTACT

jinf8865@yeah.net

86-851-86512802

Weili Wu, master

Role: CONTACT

wwlmhy@163.com

86-13885124077

Facility Contacts

Feng Jin, Bachelor

Role: primary

jinf8865@yahoo.com.cn

0851-86512802

References

Zhang M, Chen Y, Wu W, Jin F, Li Y, Long J, Luo X, Gong X, Chen X, Liu L, Tang H, Wang Z. A prospective phase II randomized study of docetaxel combined with lobaplatin versus TPF regimen induction chemotherapy followed by concurrent chemoradiotherapy for locally advanced head and neck squamous cell carcinoma. J Cancer Res Clin Oncol. 2023 Dec;149(20):18081-18091. doi: 10.1007/s00432-023-05497-1. Epub 2023 Nov 20.

Reference Type: DERIVED

PMID: 37985501 (View on PubMed)

Other Identifiers

20160819

Identifier Type: -

Identifier Source: org_study_id