NCT06472570

Brief Summary

The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H\&N tumours.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
56mo left

Started Oct 2019

Longer than P75 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress58%
Oct 2019Dec 2030

Study Start

First participant enrolled

October 26, 2019

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

June 25, 2024

Status Verified

May 1, 2024

Enrollment Period

11.2 years

First QC Date

May 21, 2024

Last Update Submit

June 24, 2024

Conditions

Head and Neck Cancer

Keywords

stereotactic radiotherapyradiosurgery boosthead and neck cancer

Outcome Measures

Primary Outcomes (1)

  • Response to treatment

    Response to treatment in imaging tests and clinical examination-local control (LC) and locoregional control (LRC).

    one month after the end of treatment, every 3 months in the first year, every 4 months in the second year, and every six months in the third-fifth years

Secondary Outcomes (5)

  • Evaluation of efficacy

    5 years after the end of treatment

  • Evaluation of efficacy

    5 years after the end of treatment

  • Evaluation of efficacy

    5 years after the end of treatment

  • Evaluation of safety Terminology Criteria for Adverse Events (CTCAE)v4.0.

    5 years after the end of treatment

  • Treatment tolerance

    an average of 3 months

Study Arms (1)

Stereotactic radiotherapy

EXPERIMENTAL

Patients treated with stereotactic radiosurgery boost. Treatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin

Radiation: Stereotactic radiotherapy boost

Interventions

Stereotactic radiotherapy boostRADIATION

A stereotactic radiosurgery boost is given in two cases: * Upfront boost-on the first day of overall treatment time (OTT) (to 6 days before beginning conventional radiotherapy). * Direct boost-on Days 43-49 of OTT in relation to conventional radiotherapy to total dose (TD) 70 Gy, i.e., up to 6 days after a dose of 60 Gy. Treatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin 100 mg/m2 or 40 mg/m2 in a 21-day or 7-day cycle, respectively Patients who start the treatment from induction chemotherapy may have a chance to qualify for an upfront or direct boost, depending the evaluation of the response to systemic treatment Prescribed doses of stereotactic boost are in the range of 10-18 Gy

Stereotactic radiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with squamous cell carcinoma (SCC) or adenoid cystic carcinoma (ACC) of the H\&N region qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy.
  • Patients with other malignant tumours of the H\&N region (sarcomas, neuroendocrine carcinomas, differentiated carcinomas, undifferentiated carcinomas, or basaloid carcinomas) qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy.
  • Patients with nonmalignant tumours of the H\&N region (tumour mixtus or paraganglioma) demanding definitive or adjuvant radiotherapy.
  • Age: 18-80 years. Biomedicines 2022, 10, 1484 5 of 12
  • Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • Conscious agreement to participate in the clinical trial.

You may not qualify if:

  • Decompensated diabetes mellitus.
  • Myocardial infarction occurred up to 6 months before.
  • Pregnancy.
  • Mental disorder preclusive of making a conscious agreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch,

Gliwice, Gliwicw, 44-102, Poland

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Paweł Polanowski

    Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paweł Polanowski, PhD

CONTACT

48322788313pawel.polanowski@gliwice.nio.gov.pl

Krzysztof Skladowski

CONTACT

48322788329krzysztof.skladowski@gliwice.nio.gov.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

June 25, 2024

Study Start

October 26, 2019

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

June 25, 2024

Record last verified: 2024-05

Locations

PL(1)