Comparison Between Tailored Surgery Versus Total Mesorectal Excision in ycT2-3N0M0
Comparison of Oncologic Outcomes Between Tailored Surgery According to Intraoperative Local Excision Biopsy Versus Total Mesorectal Excision in ycT2-3N0M0 on Magnetic Resonance Imaging After Neoadjuvant Chemoradiotherapy for Low Rectal Cancer
調査の概要
詳細な説明
Target number of subjects and calculation basis This study aims to show that the tailored treatment based on intraoperative local excision/biopsy is not oncologically inferior to total mesorectal excision. The 5-year overall survival rate expected from the existing standard treatment was 85% (van der Valk. 2018, Rullier. 2020). The non-inferior margin of the customized treatment was 10%, type 1 error 0.10, power 80%, 1:1 ratio. When calculated with a 10% dropout rate, a total of 346 people, 173 in each group, needs to be recruited.
Study Subject Recruitment Plan
- Selection and enrollment of subjects: Subjects in clinical trials must be enrolled by the investigator before starting surgical treatment.
- Document consent: To the patient who is considered to be able to participate in the clinical trial as a subject, an oral explanation of this clinical trial will be presented to the participants, and the written consent to participate in the clinical trial shall be obtained.
- Preoperative evaluation A pre-treatment examination to determine the selection of subjects and their underlying condition will be conducted. Pre-treatment examination will be performed to review whether the subject meets the selection and exclusion criteria, and subjects with significant abnormalities will be excluded.
Control group setting and randomization method Tailored treatment based on local excision and total mesorectal excision are randomly assigned 1:1 by web-based random number table (REDCap).
Statistical Analysis The statistical analyses will be conducted using intention-to-treat, and per-protocol approaches. Multiple imputation for missing covariates will be performed to determine whether there are systematic differences in terms of missing data. Analyses of the primary and secondary outcomes will be adjusted for potential co-variates.
Results of the quality of life and sexual/urinary function questionnaires will be compared using linear generalized estimating equations (GEE), adjusted for baseline values, the time effect, and the interaction effect between time and treatment.
Clinical and pathological variables will be compared using χ2 tests or Fisher's exact test for categorical variables, or with Student's t-test for continuous variables. Disease-free survival, relapse-free survival, and overall survival curves will be plotted using the Kaplan-Meier method, and differences in survival curves will be compared using the log-rank test. Multivariable analyses using the Cox regression hazard model will be conducted to identify the factors that are independently associated with disease-free survival, relapse-free survival, and overall survival. All statistical tests will be two-sided and values of p<0·05 will be considered statistically significant.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sung-Bum Kang
- 電話番号：+82-31-787-7093
- メール：kangsb@snubh.org
研究場所
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Seongnam、大韓民国、463-707
- 募集
- Seoul National University Bundang Hospital
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コンタクト：
- Sung-Bum Kang, M.D., Ph.D
- 電話番号：+82-31-787-7093
- メール：kangsb@snubh.org
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副調査官：
- Duck-Woo Kim, M.D., Ph.D.
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副調査官：
- Heung-Kwon Oh, M.D., Ph.D.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the rectum (AV≤5cm)
- Clinical ycT2-3N0 based on MRI after neoadjuvant chemoradiotherapy (including long/short-course chemoradiotherapy, total neoadjuvant therapy etc…)
- No evidence of distant metastases
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- Age 18 to 80 years
- No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician)
- Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. A woman of childbearing potential is defined of one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study.
- Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. Patients who do not read or understand Korean are eligible and may be consented according to institutional and federal regulations.
- Hemoglobin ≥ 10 g/dl (after correction for simple iron deficiency anemia), White blood cells ≥ 4,000/mm3, Platelets ≥ 100,000/mm3, Creatinine ≤ 1.5 mg/dl
- No significant dysfunction in the heart or lungs: When it is judged that the risk related to surgery due to functional impairment is not high during consultation treatment
Exclusion Criteria:
- Metastasis to the liver, lung, brain, bone, abdominal aortic lymph node, subclavian lymph node, inguinal lymph node, etc. at the time of evaluation before treatment
- Patients with a history of a prior malignancy
- Patients with serious heart disease and heart failure, severe lung disease or pulmonary insufficiency, active bacterial infection requiring parenteral antibiotic administration and/or other serious medical conditions
- Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
- When it is legally impossible to participate in a clinical trial
- Patients who are pregnant or lactating
- When existing diseases and disorders are expected to affect the quality of life evaluation after surgery
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Tailored surgery
Arm 1 will receive tailored surgery.
If there are no cancer cells or the margin is negative in the local excision/biopsy during surgery, the operation will be terminated.
And if the final pathology result is T2-4, or cancer cells and margin are positive in the frozen section during surgery, or the result of digital rectal examination and visual examination using anoretractor under general anesthesia is not suitable for local excision (visible and palpable tumor nodules), a total mesorectal excision will be performed.
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Procedure: Tailored surgery based on intraoperative local excision/biopsy
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アクティブコンパレータ：Total mesorectal excision (TME)
Arm 2 will receive TME. Surgery including high ligation of the inferior mesenteric artery and total mesorectal excision will be performed under the lithotomy position.
After pelvic dissection, double-stapled anastomosis or transanal anastomosis will be performed, followed by diverting stoma.
Abdominoperineal resection with permanent stoma is included.
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Procedure: Total mesorectal excision for all allocated patients
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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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Overall Survival (OS)
時間枠：5 years
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The percentage of people in a study or treatment group who are alive five years after their diagnosis or the date of randomization
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5 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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Immediate postoperative index
時間枠：postoperative 30 days
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Postoperative recovery index, surgery-related complications, and mortality comparison (Clavien-Dindo classification III-V), histopathologic examination of the proximal/distal/peripheral margins
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postoperative 30 days
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Oncologic outcomes
時間枠：5 years
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Rate of Disease-free Survival/Relapse-free Survival/Stoma-free Survival/Regrowth-free Survival through physical examination including digital rectal examination, carcinoembryonic antigen test (CEA), liver function test (AST/ALT), chest and abdominal CT and colonoscopy
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5 years
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Quality of Life evaluation
時間枠：Conduct a survey before surgery and every year after surgery until the 3rd year
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The Korean version of EORTC QLQ 30 which is an evaluation instrument for the quality of life of cancer patients, and the Korean version of EORTC QLQ-CR29 which is an evaluation instrument for the quality of life of colon cancer patients.
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Conduct a survey before surgery and every year after surgery until the 3rd year
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Sexual/urination function evaluation
時間枠：Conduct a survey before surgery and every year after surgery until the 3rd year
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IPSS (International Prostate Symptom Score) for urinary function test, IIEF-5 (5-item Version of the International Index of Erectile Function) for male sexual function test, FSFI (Female Sexual Function Index) for female sexual function test.
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Conduct a survey before surgery and every year after surgery until the 3rd year
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defecation function
時間枠：Conduct before surgery and at 1, 2, and 3 years after surgery, (at 1, 2, and 3 years after stoma restoration).
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MSKCC questionnaire, fecal incontinence severity index (FISI), low anterior resection syndrome (LARS) score questionnaire and fecal incontinence quality of life index (FIQL), manometry
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Conduct before surgery and at 1, 2, and 3 years after surgery, (at 1, 2, and 3 years after stoma restoration).
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
直腸がん、腺がんの臨床試験
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Tailored surgeryの臨床試験
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Bournemouth UniversityStryker Orthopaedics; Nuffield Health Bournemouth; Orthopaedic Research Institute募集
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Piazza della Vittoria 14 Studio Medico - Ginecologia...募集
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Kocaeli Derince Education and Research HospitalKocaeli Universityわからない
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University of Illinois at ChicagoEthicon Endo-Surgery引きこもった