クロロフィリンの有無にかかわらず、TNT における SCRT (SCOTCH)
クロロフィリンを使用または使用しない短期放射線療法ベースの完全術前補助療法 (SCOTCH 研究)
The goal of this clinical trial is to see, if addition of chlorophyllin to neoadjuvant Chemo-radiotherapy can reduce the gastro-intestinal/genitourinary/hematological toxicity rates and improve the quality of life in patient's diagnosed with locally advanced rectal cancer.
This is a randomized placebo control trial, wherein participants randomized to Chlorophyllin arm will receive the drug of interest along with the standard treatment. Participants randomized to other arm will receive placebo along with the standard treatment.
Researchers will compare the difference between the outcomes from both the arms and will also observe the non-operative management success rates.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
The current standard treatment for locally advanced rectal cancer includes neoadjuvant (treatment given before Surgery) radiotherapy & chemotherapy followed by surgery if needed or wait and watch in patients whom tumour has completely regressed. It has been observed that even after receiving this intensive treatment patients, almost 70% of patients develop acute toxicity (during or within 3 months) of grade 2 or higher (needing medication for toxicity). This affects their treatment tolerance, completion and quality of life.
In this study Researchers are going to see if addition of drug Chlorophyllin (derived from green plant leaves) along with standard treatment would help in reducing the acute toxicity. Chlorophyllin is present in all green leaves of plants giving them green color. The drug is derived from green plant leaves. As it is a plant-based product it is safe for humans and has no known side effects of its own. This is a randomized study which has two arms; Arm 1 is test arm where participants will receive drug of interest (Chlorophyllin) and in other arm participants will receive Placebo. Upon successful completion of study, outcomes from both the study arm will be compared and participants will be followed by standard protocol for 3 years.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ2
連絡先と場所
研究場所
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-
Maharashtra
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Mumbai、Maharashtra、インド、400012
- Tata Memorial Hospital
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Navi Mumbai、Maharashtra、インド、410210
- Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
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-
参加基準
適格基準
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:
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Age > 18 years.
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Histologically confirmed diagnosis of adenocarcinoma of the rectum.
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Clinical Stage II/III (T2-3, 4b: adherent to prostate, SV or post vagina but not grossly invading, N0-2) based on MRI.
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Non-circumferential tumours with craniocaudal length <7 cm
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The tumours of the lower rectum, or starting up to 7 cm from the anal verge.
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No evidence of distant metastases on CT Chest and Abdomen.
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No prior pelvic radiation therapy
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No prior chemotherapy or surgery for rectal cancer
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Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
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Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
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Eligible to receive one of the options of standard neoadjuvant chemotherapy as determined by the medical oncologist team.
- Absolute neutrophil count (ANC) > 1.5 cells/mm3, hemoglobin (HGB) > 8.0 gm/dl, platelet (PLT) > 150,000/mm3.
- Total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), aspartate aminotransferase (AST) ≤ 3 x ULN, alanine transaminase (ALT) ≤ 3 x ULN.
Exclusion Criteria:
- Signet or mucinous histology cancer of rectum
- Recurrent rectal cancer or previous pelvic radiotherapy
- Primary unresectable rectal cancer.
- Creatinine level greater than 1.5 times the upper limit of normal.
- Patients who are unable to undergo an MRI.
- Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
- Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
- Patients with a history of venous thrombotic episodes such as deep venous thrombosis, and pulmonary embolism occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for a trial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.
- 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.
- Poor reliability for follow up.
- Ineligible as per eligibility criteria
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：順次割り当て
- マスキング：4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Chlorophyllin
Drug name: Sodium Copper Chlorophyllin Dosage form: Tablet Dosage: 750 mg Route of administration: Oral Frequency: Once daily in the morning before food. Duration: From 10-14 days before radiotherapy up to 3 months after the last dose of cytotoxic therapy |
Additional Chlorophyllin tablet with Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose |
|
プラセボコンパレーター：Placebo
Drug Name: Placebo Dosage form: 1 Tablet Route of administration: Oral Frequency: Once daily in the morning before food. Duration: From 10-14 days before radiotherapy up to 3 months after the last dose of cytotoxic therapy |
Additional Placebo tablet with Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute Toxicity
時間枠：3 months post-last cytotoxic therapy.
|
Incidence of grade 2 or higher Common Terminology Criteria for Adverse Events (CTCAE) acute gastro-intestinal (GI)/genitourinary (GI)/haematological toxicity (HT) in advanced rectal cancer. Minimum value: Grade 1 Maximum value: Grade 5 Grade 1 late toxicity means a good outcome. Grade 2 or higher late toxicity means a worse outcome. |
3 months post-last cytotoxic therapy.
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall successful complete response rates
時間枠：3 years
|
To estimate the 3-year overall complete response rates (clinical or pathological) and complete clinical response (cCR) at 24-36 weeks post TNT in whole cohort and if any difference between chlorophyllin and control arms. |
3 years
|
|
Organ preservation rates
時間枠：3 years
|
To estimate the 3-year organ preservation rates, TME free survival and if any difference between chlorophyllin & control arms.(by estimating patients who did not need surgery for rectal cancer (Total mesorectal excision; TME) at two years and if any difference between chlorophyllin and control arms.) |
3 years
|
|
Disease free survival
時間枠：3 years
|
To estimate the 3-year disease free survival, Distant metastasis free survival, loco-regional failure free survival, and overall survival rates in the whole cohort, and if any difference between two arms and between patients with successful non-operative management versus others. |
3 years
|
|
Treatment related early and late toxicities
時間枠：2 years
|
To compare treatment-related early and late toxicities (grade 2 Common Terminology Criteria for Adverse Events, version 5.0) for two years between the groups as (3). Minimum value: Grade 1 Maximum value: Grade 5 Grade 1 late toxicity means a good outcome. Grade 2 or higher late toxicity means a worse outcome. |
2 years
|
|
Estimation of surgical complications
時間枠：30 days post surgery
|
To estimate surgical complications based on Clavien-Dindo classification. Minimum value: Grade 1 Maximum value: Grade 5 Grade 1 surgical complications means a good outcome. Grade 2 or higher surgical complications means a worse outcome. |
30 days post surgery
|
|
Health related quality of life
時間枠：2 years
|
To estimate and compare Health Related Quality of Life (QOL) between various groups as (3). (using quality of life questionnaires (QLQ) of European Organization for Research and Treatment of Cancer (EORTC)) These questionnaires will be filled by patient at six month interval of follow up. |
2 years
|
|
Cost benefit with reduction in toxicity
時間枠：2 years
|
The direct cost of per patient for various supportive medications, hospital admissions will be estimated in both arms and compared to see if any financial benefit of reduction in toxicity. Record of medicines and details of hospitalization will be maintained. |
2 years
|
|
Tumor Volume reduction kinetics
時間枠：2 years
|
To study the correlation of tumour volume with used radiotherapy doses leading to a successful non-operative management versus not in the study group of patients. |
2 years
|
|
To evaluate the timeline of Occurence
時間枠：3 years
|
To evaluate the timeline of Occurence of grade 2/3 GI toxicities (namely rectal bleeding, rectal ulcer, rectal pain, tenesmus) during SCRT based TNT. |
3 years
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Prof. Rahul Krishnatry, M.D.、Tata Memorial Hospital
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 900959
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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