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

Sponsor

National Cancer Institute, Egypt (Other)

Overall Status

Recruiting

CT.gov ID

NCT04933357

Collaborator

(none)

Enrollment

Location

Arms

35.5

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Radiation: Dose escalation Radiation: Standard dose	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging

Actual Study Start Date :

Sep 16, 2019

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose escalation	Radiation: Dose escalation Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost
Active Comparator: Standard dose	Radiation: Standard dose Standard dose to good responders to achieve dose equivalent of 70 Gy.

Arm

Intervention/Treatment

Experimental: Dose escalation

Radiation: Dose escalation

Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost

Active Comparator: Standard dose

Radiation: Standard dose

Standard dose to good responders to achieve dose equivalent of 70 Gy.

Outcome Measures

Primary Outcome Measures

Loco-regional control of HNSCC patients. [2 years loco-regional control.]

Secondary Outcome Measures

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]
Overall survival [2 years overall survival]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Institute	Cairo		Egypt	11796

Sponsors and Collaborators

National Cancer Institute, Egypt

Investigators

Study Director: Tarek Shouman, National Cancer Institute (NCI)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roa AbdulRahim El-Tagy, assistant lecturer, National Cancer Institute, Egypt

ClinicalTrials.gov Identifier:

NCT04933357

Other Study ID Numbers:

RO2010-30912

First Posted:

Jun 21, 2021

Last Update Posted: