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NCT Number: NCT06661265

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adjuvant tomotherapy +- chemotherapy after the reconstructive surgery with flaps

Procedure

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.

Primary outcomes

  1. Evaluation of acute toxicity post adjuvant treatment of tomotherapy +- chemotherapy after the reconstructive surgery with flaps

    Time frame: End of treatment course (up to 6 months)

    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).

Secondary outcomes

  1. Evaluation of the flap status at the end of the adjuvant treatment course of tomotherapy +- chemotherapy after the reconstructive surgery with flaps

    Time frame: End of treatment course (up to 6 months)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Aurora Mirabile, MD

CONTACT

[email protected]

0226433526

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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