肛門癌における同時化学放射線療法 + 5-FU + マイトマイシン-C
肛門管癌に対する5-フルオロウラシルおよびマイトマイシンCと組み合わせたペンシルビーム走査陽子線による決定的な同時化学放射線療法のパイロット実行可能性研究
This research study is a Pilot Study. Pilot studies are conducted to see if it is practical to do this type of research ona larger scale in the future. The pilot part of the study is to assess the possibility of using pencil beam proton radiation to treat your type of cancer. Proton radiation is used for many other types of malignancies, but its use for the treatment of anal cancer has been limited. The treatment is still being studied as research doctors are trying to find out more about its use in the treatment of anal cancer. Proton beam radiation therapy is an FDA approved radiation delivery system.
You are being asked to participate in this study because you have cancer in the anal canal. Conventional radiation therapy with photons in combination with 5-FU and mitomycin-C is used as standard treatment for many patients with anal cancer.
In this research study we are looking at another type of radiation called proton radiation, which is known to spare surrounding tissue and organs from radiation. Proton radiation delivers radiation to the area requiring radiation but delivers no dose beyond the region requiring treatment. There are several techniques that can be used to deliver proton radiation therapy. One of the newer techniques, called pencil beam scanning, allows for more accurate delivery of radiation to your tumor and further reduces the amount of normal tissue exposed to radiation. Most proton patients are treated with a number of beams that study doctors conform to the shape of your tumor. Pencil beam scanning delivers radiation with a single, narrow proton beam that is swept over the area of your tumor. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy, and also minimizes treatment time.
In this research study, we are evaluating the effectiveness of using pencil beam proton radiation delivered to reduce side effects associated with radiation treatment.
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
If you agree to participate in this study, you will be asked to undergo some screening tests or procedures to confirm that you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. The screening will include the following: a medical history, physical examination, biopsy of your tumor, anal and groin exam, archival tumor tissue, CT or PET-CT, MRI, blood tests and a serum pregnancy test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
Proton Radiation will be delivered daily for 5-6 weeks, depending on the dose prescribed by your physician. Treatment is delivered (Monday-Friday) for 5 days (no weekends or holidays). Each treatment will require that you lie on a table for 25-30 minutes.
You will receive radiation therapy as an outpatient at the Massachusetts General Hospital.
You will start receiving chemotherapy within 5 days of starting radiation treatment. The day you start chemotherapy will be considered Day 1.
You will receive Mitomycin-C on Days 1 and 29 of chemotherapy. Mitomycin-C will be delivered via IV infusion over a period of 10-30 minutes.
You will receive 5-fluorouracil on Day 1 and 29 of chemotherapy. You will be fitted with an ambulatory infusion pump that will administer 5-FU via IV infusion continuously over a period of 96 hours. The infusion pump will be about the size of a paperback book that can fit into a front-pack or "fanny-pack" around your waist. This pump will be connected to your body. The nurses in the infusion room will start the pump and disconnect it after 4 days.
At your 6 and 12 week follow up visits, a physical examination and the tests and procedures you receive will tell your study doctor whether your disease has gotten better, worse or stayed the same.
If your cancer has gotten better, you will continue to be monitored at your follow up visits.
If your cancer is suspected to have gotten worse, you will need to have a biopsy to confirm. If the biopsy is negative, you will need to come back for re-evaluation at 16 weeks (about 4 months) after completing radiation therapy.
If the biopsy confirms that your cancer has gotten worse, your doctor will recommend that you have surgery for the removal of your tumor.
If your cancer has stayed the same, your doctor will recommend that you have additional procedures done to develop a plan for treatment.
After you complete radiation therapy, you will be followed for up to 5 years.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 初期フェーズ 1
連絡先と場所
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104
- Roberts Proton Therapy Center of the University of Pennsylvania
-
-
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:
- Histologically or cytologically confirmed invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal
- Life expectancy of at least 3 months
Exclusion Criteria:
- Prior abdominopelvic radiotherapy
- Prior systemic therapy for anal cancer
- Pregnant or breastfeeding
- Receiving other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to mitomycin-C or 5-fluorouracil
- Prior surgery for cancer of the anus that removed all macroscopic anal cancer
- Uncontrolled intercurrent illness
- AIDS based on current CDC definition
- Other immunocompromised status
- Individuals with a history of a different malignancy are ineligible except for the following circumstances: disease-free for at least 5 years or at low risk for recurrence or cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
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）
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：Pencil Beam Scanning Radiation
Pencil Beam Radiation daily, Monday-Friday, for 5-6 weeks Mitomycin-C via IV on Days 1 and 29 5-Fluorouracil via infusion pump over 4 days, starting Day 1 and 29 of chemotherapy |
他の名前：
|
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 |
|---|---|---|
|
Number of Participants With Grade 3+ Dermatologic Toxicity
時間枠：2 years
|
Proton radiotherapy will be considered feasible if grade 3+ skin toxicity seen on this protocol is less than 48% (reported grade 3+ dermatologic toxicity from RTOG 98-11) |
2 years
|
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 |
|---|---|---|
|
Clinical Complete Response on Digital Rectal Exam
時間枠：Median follow up of 27 months
|
Overall rate of clinical complete response using digital rectal examination performed every 4 to 6 weeks until complete clinical response (cCR) up to 6 months. Patients were followed with digital rectal examination every 3 months until year 2, then every 6 months until year 5, and annual scans for 3 years thereafter. |
Median follow up of 27 months
|
|
Local Failure
時間枠：2 years
|
Estimate the rate of local failure; local failure will be measured from study entry to date of first local or regional failure |
2 years
|
|
Colostomy-Free Survival
時間枠：2 years
|
Estimate the rate of colostomy-free survival; colostomy-free survival will be measured from study entry. |
2 years
|
|
Progression Free Survival
時間枠：2 years
|
Estimate the rate of progression free survival; progression free survival will be measured from study entry to date of first local, regional, distant or second primary failure or date of death. |
2 years
|
|
Overall Survival
時間枠：2 years
|
Estimate the rate of overall survival; overall survival will be measured from study entry to 2 years |
2 years
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Jennifer Y. Wo, MD、Massachusetts General Hospital
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)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
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 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 13-075
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