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

NCT03117257 | Unknown Phase 2 DMC

• 1 other identifier: 20160819
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

Lobaplatin; head and neck cancer; chronic-chemotherapy

Outcome Measures

Primary Outcomes (2)

• National Cancer Institute CTCAE v4.0

  Acute toxicity of radiotherapy and chemotherapy

  1 year

• evaluation of immediate efficacy

  Evaluation of efficacy by RESIST1.1 standard

  1 year

Secondary Outcomes (2)

• overall survival

  5 years

• progression-free survival

  5 years

Study Arms (2)

the treatment group

EXPERIMENTAL

docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy

Drug: Lobaplatin

the control group

ACTIVE COMPARATOR

TPF induction chemotherapy combined with cisplatin chemoradiotherapy

Drug: Cisplatin

Interventions

Lobaplatin DRUG

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

Also known as: Platinum

the treatment group

Cisplatin DRUG

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

Also known as: cis-DDP; cis-Diammineplatinum(II) dichloride;

the control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and written informed consent
• Age 18-70 years old, gender is not limited
• histologically proved to be squamous cell carcinoma
• 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
• Karnofsky score ≥70
• Survival is expected to be ≥ 6 months
• Women of childbearing age should be guaranteed contraception during the study period
• (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)
• liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) \<upper limit of normal (ULN) 1.5 times; total bilirubin \<1.5 × ULN
• renal function: serum creatinine \<1.5 × ULN, endogenous creatinine clearance rate (Ccr) ≥ 55 ml / min
• no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history
• The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months).

You may not qualify if:

• There is a distant shift
• primary lesions or lymph nodes were radiotherapy
• had received epidermal growth factor targeted therapy
• primary tumor had received chemotherapy or immunotherapy
• had other malignancies (except for cured basal cell carcinoma or cervical cancer)
• pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age
• have a serious history of allergies or specific physical
• Abuse of drugs or alcohol addicts
• Person who has personality or mental illness, no civil capacity or limited civil capacity

Sponsors & Collaborators

• Guiyang Medical University: lead

Study Sites (1)

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37985501 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

lobaplatin; Platinum; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds

Study Officials

• Feng Jin, Bachelor

  Guizhou Provincial Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Feng Jin, Bachelor

CONTACT

86-851-86512802; jinf8865@yeah.net

Weili Wu, master

CONTACT

86-13885124077; wwlmhy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and neck cancer director, chief researcher, clinical professor

Study Record Dates

• First Submitted: April 2, 2017
• First Posted: April 17, 2017
• Study Start: August 19, 2016
• Primary Completion: August 19, 2019
• Study Completion: August 20, 2021
• Last Updated: April 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)