Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer (PROArCT)
A Phase II Trial of Integrated Preoperative Radiotherapy and Chemotherapy With Oxaliplatin 5-FU and Folinic Acid in Patients With Locally Advanced Rectal Cancer
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Victoria
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Melbourne、Victoria、オーストラリア、8006
- Peter MacCallum Cancer Centre
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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:
- Previously untreated and pathologically proven adenocarcinoma of the rectum.
- MRI staged T3 or T4, any N.
- Lower border of tumour must be within 12 cm of anal verge.
- Age greater than or equal to 18 years.
- ECOG Performance Status 0-1 (Appendix 2)
- Absolute neutrophil count greater than or equal to 1.5 x 109/L, haemoglobin greater than or equal to 90 g/L, and platelets greater than or equal to 100 x 109/L.
- Adequate renal function: GFR greater than or equal to 55 mL/min (derived from serum creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic techniques).
- Bilirubin and ALT less than or equal to 1.5 x upper limit of normal.
- No symptomatic peripheral neuropathy greater than or equal to grade 2.
- Male or non-pregnant, non-lactating female. Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive.
- Has provided written informed consent for participation in this trial
Exclusion Criteria:
- Presence of metastatic disease.
- Prior pelvic radiotherapy
- Febrile intercurrent illness or infection.
- Previous history of unstable angina
- Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
- Acute coronary syndrome even if controlled with medication
- Myocardial infarction within the last 12 months
- Concurrent treatment with other anti-cancer therapy.
- Significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
- Locally recurrent rectal cancer.
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：なし
- 介入モデル：単一グループの割り当て
- 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：Arm 1
Integrated Preoperative Radiotherapy (external beam radiotherapy) and Chemotherapy (Oxaliplatin, Fluorouracil and Leucovorin), then surgical resection.
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Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy. Weeks 8-10: as per Weeks 3-5
他の名前：
Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU). Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1. Week 1: (after Oxaliplatin and leucovorin)5-FU 400mg/m2 bolus Day 1, then 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1. Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1. Leucovorin 200 mg/m2 Day 1 concurrent with Oxaliplatin over 2 hrs, then 2nd: 5-FU 400 mg/m2 bolus Day 1, then 3rd: 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1
Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU) Week 6: as per Week 1, Weeks 11: as per Week 1.
Surgery is to be performed according to the standard procedure for locally advanced rectal cancer 4 to 6 weeks after completion of the integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.
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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 |
時間枠 |
|---|---|
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Tolerability Rate of patients treated with integrated pre-operative radiotherapy with FOLFOX chemotherapy regimen
時間枠：End of preoperative treatment (11 weeks)
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End of preoperative treatment (11 weeks)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Complete pathologic response rate following the completion of treatment
時間枠：Determined post-surgery
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Determined post-surgery
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Treatment Related Toxicity rates
時間枠：Determined after preoperative treatment and 30 days post-surgery
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Determined after preoperative treatment and 30 days post-surgery
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Dose Intensity of the treatment drug
時間枠：End of preoperative treatment (11 weeks)
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End of preoperative treatment (11 weeks)
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協力者と研究者
捜査官
- スタディチェア：Sam Ngan、Trans Tasman Radiation Oncology Group
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TROG 09.01
- ACTRN12610000175077 (レジストリ識別子：Australia New Zealand Clinical Trials Registry)
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