Total Neoadjuvant Therapy With Additional Consolidation Chemotherapy Followed by Local Excision Versus Total Neoadjuvant Therapy Followed by Local Excision at Stage I Rectal Cancer (OPTION)
Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial
Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial
The goal of this clinical trial is to find out if adding consolidation chemotherapy with capecitabine after total neoadjuvant chemoradiotherapy (TNT) works to improve oncologic outcomes in patients with stage I rectal cancer. It will also comparethe safety of adding consolidation chemotherapy before local excision.
The main questions it aims to answer are:
- Does adding consolidation chemotherapy increase the rate of pathologic complete response?
- What medical problems or side effects do participants have during and after treatment?
Researchers will compare TNT followed by local excision to TNT followed by consolidation chemotherapy with capecitabine and then local excision to see if adding consolidation chemotherapy improves tumor response and treatment outcomes.
Participants will:
- Receive TNT for stage I rectal cancer
- Be randomly assigned to one of two treatment groups
- Undergo local excision after preoperative treatment
- Visit the clinic for checkups and tests to evaluate tumor response, side effects, recurrence, survival, quality of life, bowel function, urinary function, sexual function, circulating tumor DNA, and treatment-related costs
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Seung-Bum Ryoo
- 電話番号：+82-010-3811-2516
- メール：sbryoomd@gmail.com
研究場所
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Jongro-gu
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Seoul、Jongro-gu、韓国、03080
- Seoul National University Hospital
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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
説明
Inclusion Criteria:
- Histologically confirmed rectall adenocarcinoma
- Low rectal cancer (AV < 15cm)
- cT2N0 disease, or pathologic stage T1N0 disease after endoscopic resection with at least one high-risk feature, including: Positive resection margin Lymphovascular invasion Tumor budding ≥5
- Ability to understand and comply with the requirements of the clinical trial
Exclusion Criteria:
- Patients who prefer radical rectal resection
- Prior history of surgery for rectal cancer
- Recurrent rectal cancer
- Synchronous metastatic rectal cancer
- Evidence of lymph node metastasis or distant metastasis on abdominopelvic CT or chest CT, including para-aortic, common iliac, or external iliac lymph node metastasis
- Uncontrolled active infection or other uncontrolled medical condition
- Known hypersensitivity to chemotherapy
- Patients considered unsuitable for participation in the clinical trial by the principal investigator or study personnel
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：独身
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：TNT with consolidation therapy
|
5-FU based CCRT: 5 weeks Rest period: 1 week 5-FU (Capecitabine) Consolidation chemotherapy 3 cycles: 8 weeks Rest period: 1 week Local excision
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アクティブコンパレータ：TNT without consolidation therapy
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5-FU based CCRT: 5 weeks Rest period: 10 weeks Local excision
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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 |
|---|---|---|
|
Pathologic complete response rate (ypT0)
時間枠：At pathologic assessment of the local excision specimen, approximately 10 weeks after completion of TNT
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Pathologic complete response of the primary tumor after neoadjuvant therapy
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At pathologic assessment of the local excision specimen, approximately 10 weeks after completion of TNT
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
5-year Survival Rate
時間枠：5 years
|
5-year Overall survival & 5-year Recurrence free survival
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5 years
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Low anterior resection syndrome (LARS)
時間枠：After local excision
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0-20, no / 21-29, minor / 30-42, major
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After local excision
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EORTC-QLQ, C30 score
時間枠：After local excision, 4weeks
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Quality of life surveillance
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After local excision, 4weeks
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Total medical costs
時間枠：5 years
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Total medical costs related to treatment, including chemoradiotherapy, chemotherapy, local excision, follow-up examinations, management of treatment-related complications, and additional treatment for recurrence, if applicable.
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5 years
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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 (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
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。