Predictors of Acute Toxicity and Flap Failure After Adjuvant Treatment for Locally Advanced Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 主要终点
- Evaluation of acute toxicity post adjuvant treatment of tomotherapy +- chemotherapy after the reconstructive surgery with flaps
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •locally advanced head and neck cancer squamocellular carcinoma
- •treated with post operative radiotherapy +/- chemotherapy
- •surgical resected with flap reconstruction
排除标准
- •salvage surgery after primary relapse
- •previously irradiated
- •recurrent/metastatic
结局指标
主要结局
Evaluation of acute toxicity post adjuvant treatment of tomotherapy +- chemotherapy after the reconstructive surgery with flaps
时间窗: 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).
次要结局
- 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))
研究者
Aurora Mirabile
Medical Oncologist
IRCCS San Raffaele
