NCT03196843

Brief Summary

The purpose of this study is to evaluate the efficacy of radiotherapy combine with raltitrexed in older patients with head and neck squamous cell carcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
202

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

2.9 years

First QC Date

June 11, 2017

Last Update Submit

August 5, 2020

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

raltitrexedradiotherapyolder patienthead and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • PFS，Progress Free Survival

    Progress free survival defined as time from the first day of treatment until disease progress or death

    2 years

Secondary Outcomes (3)

  • Incidence of Treatment-Emergent Adverse Events

    2 years

  • OS，Overall Survival

    2 years

  • DCR，Disease Control Rate

    2 years

Study Arms (2)

Raltitrexed plus Radiation

EXPERIMENTAL

Raltitrexed 2.5mg/m2, iv, every 3 weeks, concurrently with intensity modulated radiotherapy(IMRT)

Drug: RaltitrexedRadiation: Intensity Modulated Radiotherapy

Radiation

ACTIVE COMPARATOR

Intensity modulated radiotherapy(IMRT) alone radical radiotherapy:70Gy/2Gy/7 weeks preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 weeks

Radiation: Intensity Modulated Radiotherapy

Interventions

RaltitrexedDRUG

Raltitrexed 2.5mg/m2 on day 1,22,43 during radiotherapy

Raltitrexed plus Radiation
Intensity Modulated RadiotherapyRADIATION

Radical radiotherapy:70Gy/2Gy/7 weeks Preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 week

RadiationRaltitrexed plus Radiation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Before participate in the study, patients must understand the treatment plan and willing to participate in the study. Patients must have signed an approved informed consent.
  • Histopathologic confirmed squamous cell carcinoma of head and neck ,including oral cavity, oropharynx, larynx, or hypopharynx.
  • Ages≥65 years,Not limited to gender.
  • ECOG performance status ≤2.
  • Patients with surgical contraindication or reject to surgery.
  • Postoperative TNM(primary tumor,regional nodes,metastasis) staging III\~IV, positive surgical margin.
  • without evidence of distant metastases.
  • No contraindication to chemoradiotherapy.
  • Life expectancy \> 3 months.
  • Available Organ function: white blood cell≥3.5×109/L, Neutrophils ≥1.5×109/L, Hemoglobin ≥80g/L, Blood platelet\>100×109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤ 2.5 upper limit of normal(ULN); Total bilirubin (TBIL) \<1.5 ULN;serum creatinine≤1.5 ULN; creatinine clearance of ≥ 50ml/min

You may not qualify if:

  • Patients with a history of any other malignancy.
  • Concomitant treatment with any other anticancer therapy.
  • Patient have contraindication to chemotherapy(eg.uncontrolled coronarism and heart failure; History of myocardial infarction within the past 6 months, Chronic obstructive pulmonary, uncontrolled epileptic attack and other disease that investigator consider it unsuitable for the chemotherapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lv Xiupeng

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

raltitrexedRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Central Study Contacts

Xiupeng Lv, M.D.

CONTACT

+86-18098876707lvxiupeng@foxmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2017

First Posted

June 23, 2017

Study Start

September 1, 2017

Primary Completion

August 1, 2020

Study Completion

August 1, 2023

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)