Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial
調査の概要
状態
条件
詳細な説明
Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received surgery as their first treatment. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation.
Retrospective data of 218 cases in our hospital indicated patients underwent salvage chemoradiation had significantly improved survival compared with chemotherapy, radiotherapy or best supportive care. For patients with locoregional recurrence, the 1-, 3-year overall survival (OS) rates were statistically higher in patients received salvage chemoradiation than radiotherapy (1-year OS, 70.0% vs. 55.2%, 3-year OS, 41.9% vs. 23.5%, p=0.045). Patients received chemotherapy had 1-year OS of 0%.
Data of 218 cases of our hospital indicated patients received radiation dose > 54Gy had a significantly longer median overall survival time of 21.2 months compared with 11.3 months in patients had <54Gy. The optimal radiation dose should be further investigated.
The recurrence pattern of patients with esophageal cancer after esophagectomy mainly consist of supraclavicular and mediastinal lymph nodes. For patients recurred after radical surgery, prophylactic irradiation to high-risk lymph node regions should be considered. The study use simultaneously integrated boost (SIB) intensity-modulated radiation therapy (IMRT) in this trial, which made different radiation dose to recurrent tumor and high-risk lymph node regions possible.
The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery. Patients were further assigned to receive elective field irradiation (ENI) or involved field irradiation (IFI) according to tumor size, tumor location and time-to-recurrence.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Lei Deng, MD
- 電話番号：+86-18611766429
- メール：dengleipumc@163.com
研究場所
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Beijing
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Beijing、Beijing、中国、100021
- 募集
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
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コンタクト：
- Zefen Xiao, MD
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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:
- Locoregional recurrence after radical surgery;
- Positive resection margin (R1/R2) after surgery;
- Out-of-field recurrence after adjuvant chemoradiation or radiotherapy;
- Recurrence after adjuvant chemotherapy;
- No prior therapy after recurrence;
- Age 16-70 years;
- KPS>70;
- No history of drug allergy;
- Sufficient liver and kidney functions;
- White blood cell count > 4.0*10^9/L.
Exclusion Criteria:
- Age>70 or <16 years;
- Pregnancy or lactation;
- History of drug allergy;
- Declining informed consent;
- Insufficient liver or kidney functions, or abnormal CBC test;
- Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.
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：非ランダム化
- 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：Involved field irradiation
Patients after R0 surgery whose recurrence lesion larger than 5cm in diameter, or largest diameter was less than 5cm but with skip metastasis far from primary tumor or their time-to-recurrence longer than 16 months were assigned to involved field irradiation group.
For lesions far from the thoracic stomach, the prescribed dose is 60Gy/2Gy/30f, and for lesions close to the thoracic stomach, the prescribed dose is 59.4-61.2Gy/1.8Gy/33-34f.
Chest CT scan is planned at 50Gy.
Radiation field should be modified according to the tumor response.
Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks.
PEG-rhG-CSF (3-6mg) should be given after 48 hours of chemotherapy.If patients received postoperative chemotherapy of paclitaxel and platinum and went through local-regional recurrence within six months, it is allowed to deliver chemotherapy regimens in the second line.
Consolidate chemotherapy were adjusted to the patients after radiation therapy.
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Involved field irradiation; intensity-modulated radiation therapy
Paclitaxel 135-150mg/m2, d1, every 3 weeks
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
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実験的：Elective field irradiation
Patients after R1/R2 surgery or R0 surgery with the recurrence lesion whose diameter was less than 5cm without skip metastasis far from primary tumor and time-to-recurrence shorter than 16 months were assigned to elective field irradiation group.
For lesions far from the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f
with a simultaneously integrated boost up to 59.92-62.16Gy/2.14-2.22Gy/28f.
For lesions close to the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f
with a sequential boost of 10-12Gy/1.8-2Gy/5-7f.
For patients whose planned thoracic stomach V50>50%, the dose should be lowered to 45Gy/1.8Gy/25f.
Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks.
PEG-rhG-CSF should be given in need.
If patients received postoperative chemotherapy of TP and went through local-regional recurrence within 6 months, chemotherapy regimens delivered in the second line.
Consolidate chemotherapy were adjusted to the patients after radiation therapy.
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Paclitaxel 135-150mg/m2, d1, every 3 weeks
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
Elective field irradiation; intensity-modulated radiation therapy
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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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1年、2年、3年の全生存期間
時間枠：治療開始からあらゆる原因または検閲による死亡まで、最長 36 か月間評価
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全生存
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治療開始からあらゆる原因または検閲による死亡まで、最長 36 か月間評価
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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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1年、2年、3年の無増悪生存期間
時間枠：治療開始から最初に記録された進行または死亡または検閲まで、最大 36 か月まで評価
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無増悪生存
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治療開始から最初に記録された進行または死亡または検閲まで、最大 36 か月まで評価
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1-, 2-, 3-year local progression-free survival
時間枠：From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
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Local progression-free survival
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From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
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Simultaneously integrated boost radiation therapy completion rate
時間枠：During chemoradation, assessed up to 60 days
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Radiation therapy completion rate
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During chemoradation, assessed up to 60 days
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Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
時間枠：Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
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Toxicities of chemoradiation therapy
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Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
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協力者と研究者
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 (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。
食道がんの臨床試験
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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
Involved field irradiationの臨床試験
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Queen's University, BelfastUniversity of Sussexわからない
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University Hospital TuebingenAlcon Researchわからない原発性開放隅角緑内障 (POAG)ドイツ