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SarcomaPhase 2NCT00245141

Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma

A Phase 2 study testing dactinomycin, cyclophosphamide and vincristine sulfate in people with Sarcoma, run by Japan Rhabdomyosarcoma Study Group at 51 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Sarcoma
What is being tested?
dactinomycin, cyclophosphamide and vincristine sulfate
Type of treatment
Surgery or procedure
How many people
32 participants
Where
51 sitesJapan
Study dates
May 2004to Apr 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

DISEASE CHARACTERISTICS:

  • Diagnosis of embryonal rhabdomyosarcoma
  • Primary operation for pathological diagnosis within the past 42 days
  • The following variants are eligible:
  • Botryoid
  • Spindle cell
  • Anaplastic
  • Meets 1 of the following stage criteria:
  • Stage I, clinical group I or II (N0), defined by all of the following criteria:
  • Favorable site, including orbit, head, and neck (excluding parameningeal sites), genitourinary region (excluding bladder/prostate sites), or biliary tract
  • Tumor any size
  • Completely resected disease OR microscopic residual disease
  • Lymph nodes clinically negative
  • Stage I, clinical group III (N0), defined by all of the following criteria:
  • Favorable site
  • Tumor any size
  • Gross residual disease allowed (orbit only)
  • Lymph nodes clinically negative
  • Stage II, clinical group I (N0, Nx), defined by all of the following criteria:
  • Unfavorable site (any sites not listed as favorable sites)
  • Tumor ≤ 5 cm in diameter
  • Completely resected disease
  • Lymph nodes clinically negative OR lymph node involvement unknown

PATIENT CHARACTERISTICS:

Performance status

  • 0-3

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 7.5 g/dL

Hepatic

  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.5 times ULN
  • Bile acid ≤ 2.5 times ULN

Renal

  • Creatinine based on age as follows:
  • < 0.8 mg/dL (for patients < 5 years of age)
  • < 1.2 mg/dL (for patients 5-9 years of age)
  • < 1.5 mg/dL (for patients ≥ 10 years of age)

Cardiovascular

  • No severe heart disease

Other

  • Not pregnant or nursing
  • Must have acceptable organ function for age
  • No uncontrolled infection
  • No other active malignancy
  • No other treated malignancy within the past 5 years
  • No hypersensitivity to study drugs
  • No Charcot-Marie-Tooth disease
  • No chickenpox

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior anticancer chemotherapy

Endocrine therapy

  • Prior anticancer steroids allowed

Radiotherapy

  • No prior radiotherapy

Other

  • No concurrent pentostatin

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

Japan51 sites, 51 recruiting

  • Anjo Kosei Hosptial

    Anjo, Aichi-ken, 446-8602

    Yuji Miyajima, MD, 81-566-75-2111, miyajima@kosei.anjo.aichi

    Recruiting

  • National Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

    Ryohei Yokoyama, MD, 81-92-541-3231 ext. 5070, ryokoya@nk-cc.go.jp

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

    Atsushi Kikuta, MD, 81-24-547-1295

    Recruiting

  • Gifu Municipal Hospital

    Gifu, Gifu, 500-8513

    Akira Takao, MD, 81-58-251-1101, oyuki@gmhosp.gifu.gifu.jp

    Recruiting

  • Gifu University Graduate School of Medicine

    Gifu, Gifu, 500-8705

    Hideo Kaneko, 81-58-230-6386

    Recruiting

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka, 430-8558

    Tadashi Matsubayashi, 81-53-474-2222

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

    Nishimura Shinichiro, MD, 81-82-257-5212

    Recruiting

  • Osaka Medical Center and Research Institute for Maternal and Child Health

    Izumi, Osaka, 594-1101

    Keisei Kawa, MD, PhD, 81-725-56-1220, kawakei@mch.pref.osaka.jp

    Recruiting

  • Shimane Prefectural Central Hospital

    Izumo, Shimane, 693-0068

    Ken Taketani, MD, 81-853-20-2219

    Recruiting

  • Shimane University Hospital

    Izumo, Shimane, 693-8501

    Ken Taketani, MD, 81-853-20-2219, ttaketani@med.shimane-u.ac.jp

    Recruiting

  • Kagoshima University

    Kagoshima, Kagoshima-ken, 890-8520

    Yoshifumi Kawano, 81-99-275-5351, ykawano@m3.kufm.kagoshima-u.ac.jp

    Recruiting

  • Kagoshima City Hospital

    Kagoshima, Kagoshima-ken, 892-8580

    Kiyoshi Kawakami, 81-99-224-2101

    Recruiting

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, 920-02

    Seiki Horita, 81-76-237-8211, shorita@ipch.jp

    Recruiting

  • Kanazawa Medical University

    Kanazawa, Ishikawa-ken, 920-8641

    Yutaka Saikawa, MD, PhD, 81-76-265-2314, saikawa@ped.m.kanazawa-u.ac.jp

    Recruiting

  • Tokyo Metropolitan Kiyose Children's Hospital

    Kiyosei, Tokyo, 204-8567

    Takashi Kaneko, MD, 81-424-91-0011

    Recruiting

  • Kobe City General Hospital

    Kobe, Hyōgo, 650

    Ikuya Usami, 81-78-302-4321

    Recruiting

  • Dokkyo University School of Medicine

    Koshigaya, Saitama, 343-8555

    Hitoshi Ikeda, MD, 81-489-65-1111, hike@dokkyomed.ac.jp

    Recruiting

  • National Hospital Organization - Medical Center of Kure

    Kure, Hiroshima, 737-0023

    Takeo Tanaka, MD, PhD, 81-82-322-3111

    Recruiting

  • Kurume University School of Medicine

    Kurume, Fukuoka, 830-0011

    Hiroko Inada, 81-942-31-7565

    Recruiting

  • Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

    Hajime Hosoi, 81-75-251-5571, hhosoi@koto.kpu-m.ac.jp

    Recruiting

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

    Kenichiro Watanabe, MD, 81-75-751-3297, wataken@kuhp.kyoto-u.ac.jp

    Recruiting

  • Ehime Prefectural Central Hospital

    Matsuyama, Ehime, 790-0024

    Otoh Yoshiko, 81-89-947-1111

    Recruiting

  • Ibaraki Children's Hospital

    Mito, Ibaraki, 311-4145

    Kazutoshi Koike, 81-29-254-1151, kazukoike@ibaraki-kodomo.com

    Recruiting

  • Miyazaki Medical College University of Miyazaki

    Miyazaki-gun, Miyazaki, 889-1692

    Hiroshi Moritake, 81-98-585-0989

    Recruiting

  • Aichi Medical University

    Nagakuti, Aichi-ken, 480-1103

    Toshinori Hori, 81-561-62-3311

    Recruiting

  • National Hospital Orgnization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

    Keizo Horibe, MD, PhD, 81-52-951-1111, horibek@nnh.hosp.go.jp

    Recruiting

  • Osaka City University

    Osaka, Osaka, 545-8586

    Kazumi Yamato, 81-6-6645-3175

    Recruiting

  • Osaka General Medical Center

    Osaka, Osaka, 558-0056

    Keiko Yumura-Yagi, MD, 81-6-6692-1201

    Recruiting

  • Shiga University of Medical Science

    Ōtsu, Shiga, 520-21

    Shigeru Ohta, MD, 81-775-48-2228, ohta@belle.shiga-med.ac.jp

    Recruiting

  • Saitama Children's Medical Center

    Saitama, Saitama, 339-8551

    Akira Kikuchi, MD, PhD, 81-48-758-1811, a1091069@pref.saitama.jp

    Recruiting

  • Sapporo Medical University

    Sapporo, Hokkaido, 060-8556

    Nobuhiro Suzuki, MD, PhD, 81-11-611-2111

    Recruiting

  • Hokkaido University Graduate School of Medicine

    Sapporo, Hokkaido, 060-8638

    Ryoji Kobayashi, MD, 81-11-706-5954

    Recruiting

  • Hokkaido Medical Center for Child Health and Rehabilitation

    Sapporo, 006-0041

    Tooru Kudoh, MD, PhD, 81-11-691-5696

    Recruiting

  • Gunma Children's Medical Center

    Seta-gun, Gunma, 377-8577

    Manabu Sotomatsu, MD, 81-279-52-3551, sotomatsu@gcmc.pref.gunma.jp

    Recruiting

  • Osaka City General Hospital

    Suita-shi, Osaka, 565-0871

    Junichi Hara, 81-6-6929-1221

    Recruiting

  • Osaka University Graduate School of Medicine

    Suita-shi, Osaka, 565-0871

    Hideaki Ohta, MD, PhD, 81-6-6879-3937, ohta@ped.med.osaka-u.ac.jp

    Recruiting

  • Osaka Medical College

    Takatsuki, Osaka, 569-8686

    Tomoko Kuno, 81-72-683-1221

    Recruiting

  • National Defense Medical College

    Tokorozawa, Saitama, 359-8513

    Kazuhiro Kogawa, 81-4-2995-1621

    Recruiting

  • National Center for Child Health and Development

    Tokyo, Kanagawa, 157-8535

    Masa-aki Kumagai, MD, 81-3-3416-0181, kumagai-ma@ncchd.go.jp

    Recruiting

  • National Cancer Center Hospital

    Tokyo, Tokyo, 104-0045

    Atsushi Makimoto, 81-3-3542-2511

    Recruiting

  • St. Luke's International Hospital

    Tokyo, Tokyo, 104

    R. Hosoya, MD, 81-3-3541-5151

    Recruiting

  • Tokyo Medical and Dental University

    Tokyo, Tokyo, 113-8510

    Masayuki Nagasawa, 81-3-5803-5246

    Recruiting

  • Toho University School of Medicine

    Tokyo, Tokyo, 143-8541

    Akira Ohara, 81-3-3762-4151

    Recruiting

  • Keio University School of Medicine

    Tokyo, Tokyo, 160-8582

    Yasuhide Morikawa, MD, 81-3-5363-2593, ymorikaw@sc.itc.keio.ac.jp

    Recruiting

  • Nihon University Itabashi Hospital

    Tokyo, Tokyo, 173

    Hideo Mugishima, MD, 81-3-3972-8111 ext. 2700

    Recruiting

  • Toyama University Hospital

    Toyama, Toyama, 930-0194

    Hirokazu Kanegane, 81-76-434-7313, kanegane@ms.toyama-mpu.ac.jp

    Recruiting

  • Nagano Children's Hospital

    Toyoshina-machi, Nagano, 399-8288

    Eizaburo Ishii, 81-263-73-6700

    Recruiting

  • University of Tsukuba

    Tsukuba, Ibaraki, 305-8575

    Michio Kaneko, MD, PhD, 81-29-853-3094, mkaneko@md.tsukuba.ac.jp

    Recruiting

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

    Mitsui Tetsuo, MD, DMedSci, 81-23-628-5329, tmitsui@med.id.yamagata-u.ac.jp

    Recruiting

  • Showa University Fujigaoka Hospital

    Yokohama, Kanagawa, 227-8502

    K. Isoyama, 81-45-971-1151, isoyama@syowa-univesity-fujigaoka.gr.jp

    Recruiting

  • Yokohama City University

    Yokohama, Kanagawa, 236-0004

    Hiroaki Goto, 81-45-787-2800

    Recruiting

Other trials in Japan

About this study

Official title: Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma

RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.

Read the detailed description

OBJECTIVES:

  • Determine the progression-free survival rate in patients with low-risk embryonal rhadomyosarcoma treated with a shortened treatment schedule of vincristine, dactinomycin, and cyclophosphamide with or without radiotherapy.

OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of 24 weeks) in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Conditions
Sarcoma
Being tested
dactinomycin, cyclophosphamide, vincristine sulfate, radiation therapy
Keywords
embryonal childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival as measured by Kaplan-Meier method 3 years after study entry

Secondary outcomes (4)

  1. Overall survival as measured by Kaplan-Meier method 3 years after study entry

  2. Progression-free survival as measured by Kaplan-Meier method during events

  3. Complete response rate (orbit, group III only) at completion of study treatment

  4. Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2005 (estimated)
  2. Study startMay 2004
  3. Primary completionApr 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00245141
Sponsor's protocol ID
JRSG-UHA-PED03-01
Other IDs
CDR0000453316
Status last verified
Jul 2009
First submitted
25 Oct 2005
Last updated
12 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dactinomycin, cyclophosphamide and vincristine sulfate in people with Sarcoma, run by Japan Rhabdomyosarcoma Study Group at 51 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival as measured by Kaplan-Meier method 3 years after study entry. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00245141.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.

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