Multimodality- Adapted Dose Modification in Head and Neck... | NCT04933357

Studies
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy

NCT04933357

Sponsor

National Cancer Institute, Egypt

Status

Unknown status

Last Update Posted

Jun 21, 2021Actual

Enrollment

75Estimated

Phase

Phase 2Phase 3

Conditions

Head and Neck Cancer

Interventions

Dose escalation
Standard dose

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2019Actual

Primary Completion Date

Sep 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Jun 15, 2021

First Submission Date that Met QC Criteria

Jun 15, 2021

First Posted Date

Jun 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2021

Last Update Posted Date

Jun 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective trial evaluating dose escalation using an SBRT boost to poor- responding tumors by interim functional imaging (PET/CT and fMRI) to improve the local control of HNCSCC.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose escalation	Experimental		Radiation: Dose escalation
Standard dose	Active Comparator		Radiation: Standard dose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dose escalation	Radiation	Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost	Dose escalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Loco-regional control of HNSCC patients.		2 years loco-regional control.

Secondary Outcomes

Measure	Description	Time Frame
Acute radiation toxicity		During treatment and up to 6 months post treatment.
Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.		2-4 weeks after start of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

More than or equal to 18 years old. ECOG Performance Scale (0-2). Histological confirmation of SCC of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx.

Clinical stage II-IVB (AJCC, 8th edition). Multidisciplinary decision of radical radiation or concurrent chemoradiotherapy (CCRT).

Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

Stage I/II glottic cancer. Patients who underwent surgery for the primary tumor location. Distant metastases. Inability to undergo PET-CT or MRI. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease- free for a minimum of 5 years. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation fields. Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roa El-Tagy	Contact	002-01222410771		roa.eltagy@gmail.com
May Ashour	Contact			may25s@hotmail.com

Overall Officials

Name	Affiliation	Role
Tarek Shouman	National Cancer Institute (NCI)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute	Recruiting	Cairo		11796	Egypt

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms