Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer
2016年3月29日 更新者：Lorenzo Fuccio、IRCCS Azienda Ospedaliero-Universitaria di Bologna
Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer: A Phase II Study.
Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival.However, patients with T4 rectal cancer show high risk of local recurrence after conventional treatment.
Therefore investigators designed a prospective Phase II study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy.
調査の概要
詳細な説明
Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival.
However, patients with T4 rectal cancer show high risk of local recurrence (LR) after conventional treatment.
This was a prospective Phase II study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy.
The primary aim was to assess the pathological complete response rate.
Key secondary aim was the resectability.
Secondary aims were evaluation of treatment-related acute and late toxicity, local control, disease-free survival and overall survival (OS).
The follow-up period of each subjects started after the radiochemotherapy treatment and ended after a maximum of 36 months of observation or until death.
研究の種類
介入
入学 (実際)
18
段階
- フェーズ2
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Histologically proven locally advanced (T4N0-2) or locally recurrent rectal adenocarcinoma;
- Age ≥ 18 years;
- Eastern Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion Criteria:
- Metastatic patients
- unfit surgery patients,
- pregnant or breast feeding females
- patients with clinically detectable ascites
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
|
実験的：Radiotherapy plus Tom-Ox
Patients received concomitant boost RT (55 Gy/5 weeks) with concurrent Tom-Ox chemotherapy.
The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.
|
Radiotherapy was applied as conformal 3-D technique and was delivered with photon energies of 10 - 15 MV.
The beams were delivered by an Elekta Precise Linac equipped with standard multi leaf collimators (MLC).
A daily online check of isocenter position was performed using portal imaging, with set-up correction in case of displacement > 0.5 cm in any direction.
Radiation dose delivered to PTV2 was 45 Gy (1.8 Gy/fraction) with a concomitant boost dose to the PTV1 of 10 Gy with accelerated fractionation at 2.2 Gy/fraction, five consecutive days for week.
The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.
他の名前：
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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 |
|---|---|---|
|
Number of patients defined as good responders (G1 or G2) according to the Mandard regression grading system.
時間枠：8 weeks after chemo-radiotherapy
|
Pathologic responses of the primary tumours were defined according to the Mandard regression grading system: grade 1 was recorded when no tumour cells remained in the primary tumour and lymph nodes (pCR); grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis; grade 3 was characterized by an increase in the number of residual cancer cells, but fibrosis still predominated; grade 4 showed residual cancer outgrowing fibrosis; and grade 5 was characterized by an absence of regressive changes.
Good responders were defined those patients with a pathologic response with Mandard G1 or G2 and poor responder patients with Mandard G3, G4 or G5.
|
8 weeks after chemo-radiotherapy
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of patients in which a surgical resection was feasible
時間枠：8 weeks after chemo-radiotherapy
|
8 weeks after chemo-radiotherapy
|
|
|
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
時間枠：Up to 36 months. In details, follow-up examinations were performed 4 weeks after surgery and every 6 months until the established length of follow-up or death.
|
CTCAE v 3.0 was used to score acute and late radiation toxicity.
|
Up to 36 months. In details, follow-up examinations were performed 4 weeks after surgery and every 6 months until the established length of follow-up or death.
|
|
The number of patients without disease (i.e. rectal cancer) during the follow-up.
時間枠：Up to 36 months.
|
The disease-free survival (DFS) was defined as the time from the diagnosis to the documented local or distant recurrence or last follow-up.
|
Up to 36 months.
|
|
The number of patients still alive at the end of follow-up
時間枠：Up to 36 months
|
The overall-survival (OS) was defined as the time from the diagnosis until death for any cause or the last follow-up.
|
Up to 36 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Alessio G Morganti, Prof、Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2005年1月1日
一次修了 (実際)
2008年1月1日
研究の完了 (実際)
2012年2月1日
試験登録日
最初に提出
2016年3月19日
QC基準を満たした最初の提出物
2016年3月29日
最初の投稿 (見積もり)
2016年3月30日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年3月30日
QC基準を満たした最後の更新が送信されました
2016年3月29日
最終確認日
2016年3月1日
詳しくは
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