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

NCT06661265 | Not Yet Recruiting

• 1 other identifier: Lembi
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Keywords

flap reconstructions; flaps; Head and Neck cancer; toxicities; adjuvant chemoradiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  End of treatment course (up to 6 months)

Study Arms (1)

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

Interventions

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.

SCCHN patients undergoing to upfront surgery with flap reconstruction followed by adjuvant treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surgical Flaps

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Surgically-Created Structures; Equipment and Supplies

Central Study Contacts

Aurora Mirabile, MD

CONTACT

0226433526; mirabile.aurora@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 28, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10