SCARLET - Italian proSpeCtionAl obseRvationaL multicEntre Study on Treatment for recTal pT1 Cancer (SCARLET)
調査の概要
状態
条件
詳細な説明
Background To date, the therapeutic management of patients with pathological T1 (pT1) rectal cancer after local surgical or endoscopic excision remains a subject of ongoing debate. Although traditional radical surgery has demonstrated proven advantages, discussion persists regarding the adequacy of less invasive techniques for specific subgroups of patients, particularly those with a low risk of disease progression. In these cases, local excision options through endoscopic or surgical interventions, including Endoscopic Submucosal Dissection (ESD), Transanal Minimally Invasive Surgery (TAMIS), and Transanal Endoscopic Microsurgery (TEM), may represent a valid curative approach. These techniques, which generally carry a low risk of lymph node metastasis, offer important advantages in terms of organ preservation and reduction of postoperative complications, including anorectal, urinary, and sexual dysfunction, which may significantly impair quality of life.
Rationale The choice of a conservative approach must be carefully evaluated, especially when post-excision histopathological analysis reveals high-risk features. These include deep submucosal invasion greater than 1 mm, poor tumor differentiation, tumor budding, lymphovascular invasion, or positive or close resection margins. In these situations, radical surgery with Total Mesorectal Excision (TME) is considered the standard treatment strategy for reducing the risk of local and nodal recurrence, although available evidence is largely derived from retrospective studies. Because TME may substantially affect quality of life and functional outcomes, treatment decisions should be discussed within a multidisciplinary team. National and international guidelines suggest that patients with pT1 rectal cancer who present high-risk features and are either unwilling or unsuitable to undergo radical surgery may be considered for alternative organ-preserving strategies, including adjuvant radiotherapy or chemoradiotherapy.
Study Objective This prospective, observational, multicenter study aims to evaluate the impact of adjuvant radiotherapy or chemoradiotherapy on Disease-Free Survival (DFS) in patients with pT1 rectal cancer presenting at least one high-risk histopathological feature who have undergone local excision and declined treatment with TME. The study will also assess long-term oncologic outcomes, organ preservation, and quality of life in this patient population.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Giuditta Chiloiro, MD, Phd
- 電話番号：06-30154981
- メール：giuditta.chiloiro@policlinicogemelli.it
研究場所
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RM
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Roma、RM、イタリア、00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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コンタクト：
- Giuditta Chiloiro, MD, Phd
- 電話番号：06-30154981
- メール：giuditta.chiloiro@policlinicogemelli.it
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age 18 years or older.
- Good performance status (Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1).
- Primary tumor of the distal rectum (clinical T1) amenable to local endoscopic resection using Endoscopic Submucosal Dissection (ESD) or local surgical resection using Transanal Endoscopic Microsurgery (TEM) or Transanal Minimally Invasive Surgery (TAMIS).
High-risk pathological T1 rectal cancer meeting at least one of the following conditions:
i) Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma.
ii) Pathological submucosal invasion greater than 1000 micrometers. iii) Positive lymphatic invasion or positive venous invasion confirmed by immunohistochemistry.
iv) Tumor budding grade 2 or 3. v) Positive lateral or vertical resection margin (tumor within 1 mm of the surgical margin) or non-assessable resection margin.
- No lymph node or distant metastases confirmed by computed tomography of the chest, abdomen, and pelvis (clinical N0, M0 disease).
- Radiotherapy or chemoradiotherapy initiated within 12 weeks after local endoscopic or surgical resection.
- No previous rectal resection (other than local excision) or pelvic irradiation for any malignancy.
- Adequate organ function as assessed by the treating physician.
- The treating surgeons have explained to the patient that the current standard of care is Total Mesorectal Excision (TME) with D2 lymph node dissection and the patient has declined this treatment.
- Candidate for adjuvant chemoradiotherapy according to routine clinical practice.
- Written informed consent provided.
Exclusion Criteria:
- Synchronous or metachronous malignancy diagnosed within the previous 5 years.
- Infection requiring systemic treatment.
- Requirement for continuous systemic treatment with corticosteroids or immunosuppressive agents.
- Diagnosis of a hereditary colorectal cancer syndrome, including familial adenomatous polyposis or Lynch syndrome, or diagnosis of inflammatory bowel disease, including ulcerative colitis or Crohn disease.
- Squamous cell carcinoma, neuroendocrine neoplasm, or mixed neuroendocrine-non-neuroendocrine neoplasm histology.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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3-year Disease-Free Survival (DFS)
時間枠：3-years
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Percentage of patients who remain alive and free from rectal cancer recurrence (local, nodal, or distant metastases) at three years from the start of follow-up.
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3-years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Disease-free survival at 1 year
時間枠：1 year
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Percentage of patients alive and free from rectal cancer recurrence (local, nodal, or distant metastases) at 1 year from follow-up.
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1 year
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Disease-free survival at 5 years
時間枠：5 years
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Percentage of patients alive and free from rectal cancer recurrence (local, nodal, or distant metastases) at 5 years from follow-up.
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5 years
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Local recurrence-free survival at 1 year
時間枠：1 year
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Time from the end of treatment to the documentation of local disease recurrence at 1 year.
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1 year
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Local recurrence-free survival at 3 years
時間枠：3 years
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Time from the end of treatment to the documentation of local disease recurrence at 3 years.
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3 years
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Local recurrence-free survival at 5 years
時間枠：5 years
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Time from the end of treatment to the documentation of local disease recurrence at 5 years.
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5 years
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Overall survival at 1 year
時間枠：1 year
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Percentage of patients alive at 1 year from the start of follow-up.
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1 year
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Overall survival at 3 years
時間枠：3 years
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Percentage of patients alive at 3 years from the start of follow-up.
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3 years
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Overall survival at 5 years
時間枠：5 years
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Percentage of patients alive at 5 years from the start of follow-up.
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5 years
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Colostomy-free survival at 1 year
時間枠：1 year
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Percentage of patients alive without the need for a temporary or permanent stoma/colostomy at 1 year.
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1 year
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Colostomy-free survival at 3 years
時間枠：3 years
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Percentage of patients alive without the need for a temporary or permanent stoma/colostomy at 3 years.
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3 years
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Quality of life assessed by EORTC QLQ-C30 Global Health Status/Quality of Life score at 1 year
時間枠：1 year
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Patient-reported quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
The Global Health Status/Quality of Life score ranges from 0 to 100 after linear transformation.
Higher scores indicate better quality of life.
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1 year
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Colorectal cancer-specific quality of life assessed by EORTC QLQ-CR29 at 1 year
時間枠：1 year
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Patient-reported colorectal cancer-specific quality of life assessed using the European Organisation for Research and Treatment of Cancer Colorectal Cancer Questionnaire (EORTC QLQ-CR29).
Questionnaire scores are transformed to a 0-100 scale.
For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate greater symptom burden.
Individual QLQ-CR29 scale scores will be analyzed separately.
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1 year
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Quality of life assessed by EORTC QLQ-C30 Global Health Status/Quality of Life score at 3 years
時間枠：3 years
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Patient-reported quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
The Global Health Status/Quality of Life score ranges from 0 to 100 after linear transformation.
Higher scores indicate better quality of life.
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3 years
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Colorectal cancer-specific quality of life assessed by EORTC QLQ-CR29 at 3 years
時間枠：3 years
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Patient-reported colorectal cancer-specific quality of life assessed using the European Organisation for Research and Treatment of Cancer Colorectal Cancer Questionnaire (EORTC QLQ-CR29).
Questionnaire scores are transformed to a 0-100 scale.
For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate greater symptom burden.
Individual QLQ-CR29 scale scores will be analyzed separately.
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3 years
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Acute toxicity within 6 months from treatment
時間枠：Within 6 months from the end of treatment
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Incidence and severity of acute adverse events (genitourinary, gastrointestinal, and hematologic) scored according to CTCAE version 5.0.
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Within 6 months from the end of treatment
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Late toxicity at 2 years after the end of treatment
時間枠：2 years after the end of treatment
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Incidence and severity of long-term treatment-related toxicities scored according to CTCAE version 5.0.
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2 years after the end of treatment
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Nodal Recurrence Rate
時間枠：Up to 5 years after completion of adjuvant treatment.
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ercentage of patients who develop regional lymph node recurrence during the follow-up period, as assessed by imaging modalities.
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Up to 5 years after completion of adjuvant treatment.
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Distant Metastases Rate
時間枠：Up to 5 years after completion of adjuvant treatment.
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Percentage of patients who develop distant organ metastases (outside the pelvis) during the follow-up period, confirmed by contrast-enhanced chest-abdomen-pelvis CT scan.
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Up to 5 years after completion of adjuvant treatment.
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協力者と研究者
捜査官
- 主任研究者：Giuditta Chiloiro, MD, PhD、Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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