NCT05039606

Brief Summary

This study was designed as a prospective, multicenter and randomized clinical study of radiotherapy combined with Nedaplatin contrast and cisplatin for local advanced head and neck squamous SCC, aiming to explore the efficacy, safety and long-term efficacy of this trial and control groups and provide some evidence for the selection of clinical treatment options.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for phase_2

Timeline
4mo left

Started Sep 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Sep 2021Sep 2026

First Submitted

Initial submission to the registry

September 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

September 1, 2021

Last Update Submit

September 1, 2021

Conditions

Head and Neck Squamous Carcinoma

Keywords

Local advanced head and neck squamous carcinomaNedaplatinAdverse reactionsEfficacy

Outcome Measures

Primary Outcomes (2)

  • NCI CTCAE 5.0

    Acute virulence side response

    1 year

  • RESIST1.1

    Use to assess recent efficacy

    1year

Secondary Outcomes (2)

  • overall survival

    5 years

  • Progression-free survival rate

    5 years

Study Arms (2)

the treatment group

EXPERIMENTAL

Nedplatin combined with intensive radiotherapy group

Drug: Nedaplatin

the control group

ACTIVE COMPARATOR

Cisplatin was combined with the IMRT group

Drug: Cisplatin

Interventions

NedaplatinDRUG

Nedaplatin is a second-generation platinum-like derivative, which is a cell cycle non-specific drug, with a mechanism of action and efficacy similar to cisplatin, and a wide anti-cancer spectrum

the treatment group
CisplatinDRUG

Cisplatin, aka cis-dichlorodiamineplatin, is a platinum-containing anticancer drug

the control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • voluntarily participated and signed the informed consent form in writing
  • is 18-70 and gender unlimited
  • histologically proved to be squamous cell carcinoma
  • as AJCC(version 8): -A, ⅣB head and neck squamous carcinoma unable or denied surgery; \~ A, ⅣB squamous carcinoma of the head and neck with the following postoperative risk factors: positive or proximal resection, lymph node envelope invasion, nerve and vascular invasion, primary focal pT3 or T4, N2 or N3 lymph node lesions.
  • card score ≥ 70
  • survival is expected to be ≥ for 6 months
  • fertility women should guarantee contraception during entering the study
  • Hemoglobin (HGB) ≥ 100 g/L, leukocyte (WBC) ≥ 3.5 × 10\^9 / L\*(unit normal), Platelet (PLT) ≥ 100 × 10\^9 / L(unit normal), neutrophil (WBC) ≥ 1.5 × 10\^9 / L\*(unit normal)
  • liver function: 2.5 times of the upper normal limit (ULN), gluten transaminase (ASAT) \<; total bilirubin \<1.5 × ULN
  • renal function: Serum creatinine \<ULN, endogenous creatinine clearance (Ccr) ≥ 55 ml/min
  • has no severe complications such as hypertension, diabetes, coronary heart disease, and psychiatric history
  • (no history of head and neck radiotherapy or chemotherapy within 3 months)

You may not qualify if:

  • has a distant transfer
  • has received epidermal growth factor targeted or immunotherapy
  • has developed other malignant tumors (except for cured basal cell carcinoma or cervical carcinoma in situ)
  • pregnant women or lactating women and women of childbearing age who refuse contraception during the treatment observation period
  • has a serious history of severe allergies or abnormalities
  • refused or cannot sign an informed consent to participate in the trial
  • substance abuse or alcohol addicts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

Location

MeSH Terms

Interventions

nedaplatinCisplatin

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Feng Jin, Bachelor

    The Affiliated Cancer Hospital of Guizhou Medical University

    STUDY CHAIR

Central Study Contacts

Feng Jin, Bachelor

CONTACT

86-851-86512802jinf8865@yeah.net

Weili Wu, Master

CONTACT

86-13885124077wwlmhy@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

September 1, 2021

First Posted

September 9, 2021

Study Start

September 1, 2021

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)