Predictors of Acute Toxicity and Flap Failure After Adjuvant Treatment for Locally Advanced Head and Neck Cancer

Head and Neck cancer treatment may have significant functional consequences. Decisions about treatment are usually hard to make, as they must strike a balance between efficacy of the treatment and likelihood of survival. Reconstructive surgery with flaps plays a key role in the head and neck cancer resection in order to achieve local control, but often leaves a large, disfiguring composite defect that not only compromises the patient's functional and aesthetic outcome, but also significantly affects quality of life.

Adjuvant treatment, including post operative Radiation Therapy (poRT) and chemotherapy, is crucial in improving locoregional control and survival in locally-advanced cases and the flaps are usually included in radiotherapy fields.

Fourthysix patients undergoing to reconstructive surgery followed by radiation or chemioradiation between Decembre 2017 to December 2022 at San Raffaele Hospital will be enrolled in this study. The first aim of the study is to understand potential predictors of the occurrence of overall acute toxicity following adjuvant treatment in locally-advanced head and neck cancers submitted to upfront surgery with flap reconstruction. By analyzing patient data and treatment variables, the study aims at identifying factors that may influence the incidence and severity of acute treatment-related toxicities, such as mucositis, dysphagia, xerostomia and dermatitis.

The second aim of the study is to evaluate whether the same variables may influence the viability and integrity of the flap at the end of the adjuvant treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Procedure: adjuvant tomotherapy +- chemotherapy after the reconstructive surgery with flaps

• Study Type: Observational
• Enrollment (Estimated): 46

Contacts and Locations

• Study Contact: Name: Aurora Mirabile, MD; Phone Number: 0226433526; Email: mirabile.aurora@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Locally-advanced head and neck cancers' patients undergone adjuvant treatment after upfront surgery with flap reconstruction

Description

Inclusion Criteria:

• locally advanced head and neck cancer squamocellular carcinoma
• treated with post operative radiotherapy +/- chemotherapy
• surgical resected with flap reconstruction

Exclusion Criteria:

• salvage surgery after primary relapse
• previously irradiated
• recurrent/metastatic

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SCCHN patients undergoing to upfront surgery with flap reconstruction followed by adjuvant treatment; Head and Neck cancer patients undergoing to upfront surgery with flap reconstruction followed by radiotherapy or chemioradiotherapy at San Raffaele Hospital between December 2017-December 2022.	Procedure: adjuvant tomotherapy +- chemotherapy after the reconstructive surgery with flaps; adjuvant treatment in locally-advanced head and neck cancers submitted to upfront surgery with flap reconstruction, evaluation of toxicity and flap status performed at San Raffaele Hospital between December 2017-December 2022.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of acute toxicity post adjuvant treatment of tomotherapy +- chemotherapy after the reconstructive surgery with flaps	Acute toxicity post adjuvant treatment of tomotherapy +- chemotherapy after the reconstructive surgery with flaps will be measured according to Standard Common Criteria for Adverse Events (CTCAE) v5, thus graded as low (G0-1) versus relevant (G2 or more).	End of treatment course (up to 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the flap status at the end of the adjuvant treatment course of tomotherapy +- chemotherapy after the reconstructive surgery with flaps	Flap status will be categorized as Healthy (a successful reconstruction with good blood supply, intact tissue viability, and absence of complications) versus Damaged (complications such as partial or total flap loss, flap necrosis, and wound dehiscence, managed with either conservative procedures or revision surgery).	End of treatment course (up to 6 months)

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: flaps; Head and Neck cancer; toxicities; adjuvant chemoradiation; flap reconstructions
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: Lembi

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No