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

NCT06661265 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2024-12-31
Completion
2024-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06661265 on ClinicalTrials.gov