Clinical trial NCT06661265: Predictors of Acute Toxicity and Flap Failure After Adjuvant Treatment for Locally Advanced Head and Neck Cancer
Official title: Predictors of Acute Toxicity and Flap Failure After Adjuvant Treatment for Locally Advanced Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Head and Neck Cancer
Keywords: flap reconstructions
flaps
Head and Neck cancer
toxicities
adjuvant chemoradiation
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally-advanced head and neck cancers' patients undergone adjuvant treatment after upfront surgery with flap reconstruction

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of acute toxicity post adjuvant treatment of tomotherapy +- chemotherapy after the reconstructive surgery with flaps
timeFrame: End of treatment course (up to 6 months)
Secondary outcomes:
measure: Evaluation of the flap status at the end of the adjuvant treatment course of tomotherapy +- chemotherapy after the reconstructive surgery with flaps
timeFrame: End of treatment course (up to 6 months)
Other outcomes:
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