Terminé

Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma

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Ce qui est testé

conventional surgery

+ dactinomycin

+ cyclophosphamide

ProcédureMédicamentRadiothérapies
Qui peut participer

Myosarcome+5

+ Néoplasmes du Tissu Musculaire

+ Néoplasmes par type histologique

Jusqu'à 49 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 3
Interventionnel
Date de début : septembre 2004
Voir le détail du protocole

Résumé

Sponsor principalChildren's Oncology Group
Dernière mise à jour : 14 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Date de début de l'étude : 4 septembre 2004

Date à laquelle le premier participant a commencé l'étude.

PRIMARY OBJECTIVES: I. Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine (V), dactinomycin (A), cyclophosphamide (C), and radiotherapy. SECONDARY OBJECTIVES: I. Determine local control rates in patients treated with this regimen. II. Determine the rate of second-look surgery in patients with bulk residual tumor at diagnosis (clinical group III) and the proportion of second-look surgeries that render patients treated with this regimen tumor-free or with microscopic tumor only and evaluate the pathologic significance of that residual tumor. III. Determine the local control rates in patients with clinical group III disease treated with response-adjusted radiotherapy doses after second-look surgical resection. OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group. REGIMEN I (subset 1 patients) \[closed to accrual as of 08/13/2010: Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and dactinomycin\* IV over 1 minute on day 1 of weeks 13, 16, 19, and 22; and radiotherapy\*\*, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. REGIMEN II (subset 2 patients)\[closed to accrual as of 9/23/2011\]: Patients receive VAC chemotherapy and radiotherapy\*\* as in regimen I and VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin\* IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46. Patients with clinical group III disease may undergo second-look surgery at week 13 followed by response-adjusted radiotherapy, and continued VA\* chemotherapy. In both regimens, treatment continues in the absence of disease progression or unacceptable toxicity. NOTE: \*For both regimens, dactinomycin is omitted during radiotherapy. NOTE: \*\*Clinical Group I tumors and those with Clinical Group III uterine/cervix primary disease with negative nodes who have undergone a complete resection (i.e. hysterectomy) at Week 13 do not receive radiotherapy at Week 13 Patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Titre officielVincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma 
NCT00075582
Sponsor principalChildren's Oncology Group
Dernière mise à jour : 14 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

390 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

Jusqu'à 49 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

MyosarcomeNéoplasmes du Tissu MusculaireNéoplasmes par type histologiqueNéoplasmesRhabdomyosarcomeSarcomeNéoplasmes, tissu conjonctif et tissu mouRhabdomyosarcome embryonnaire

Critères

Inclusion Criteria: * Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting criteria for 1 of the following subsets: * Subset 1, defined by meeting 1 of the following criteria (closed to accrual as of 08/13/2010): * Stage 1 and clinical group I (completely resected) or II (microscopic residual disease and/or regional lymph node involvement) disease * Stage 1 and clinical group III (gross residual disease) disease arising in the orbit * Stage 2 and clinical group I or II disease * Subset 2, defined by meeting 1 of the following criteria (closed to accrual as of 09/23/2011): * Stage 1 and clinical group III disease arising in a non-orbit site * Stage 3 and clinical group I or II disease * Prior staging ipsilateral retroperitoneal lymph node dissection required for all patients age 10 and over with paratesticular tumors and patients under 10 years of age with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement is identified by imaging studies) * If there is extensive gross node involvement only confirmatory node biopsy is recommended and the patient is classified as Clinical Group III * Prior regional lymph node sampling required for patients with extremity tumors * None of the following diagnoses: * Intermediate-risk embryonal RMS * Metastatic embryonal RMS * Alveolar RMS * Undifferentiated sarcoma * RMS not otherwise specified (NOS) * Other soft tissue sarcoma, including sarcoma NOS * Prior enrollment on clinical trial COG-D9902 * Performance status - ECOG 0-2 * Performance status - Karnofsky 50-100% (≥ 16 years old) * Performance status - Lansky 50-100% (\< 16 years old) * Absolute neutrophil count at least 750/mm\^3 * Platelet count at least 75,000/mm\^3 (transfusion independent) * Bilirubin no greater than 1.5 times upper limit of normal (ULN)\* * Creatinine\* based on age/gender as follows: * No greater than 0.8 mg/dL for patients age 5 and under * No greater than 1.0 mg/dL for patients age 6 to 9 * No greater than 1.2 mg/dL for patients age 10 to 12 * No greater than 1.4 mg/dL for female patients age 13 and over * No greater than 1.5 mg/dL for male patients age 13 to 15 * No greater than 1.7 mg/dL for male patients age 16 and over * Creatinine clearance\* or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m\^2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection * No prior chemotherapy (except for patients treated on the related intermediate-risk study) * Prior steroids allowed * No prior radiotherapy

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).

Groupe II

Expérimental
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 163 sites

Suspendu

University of Alabama at Birmingham

Birmingham, United StatesVoir le site
Suspendu

Phoenix Childrens Hospital

Phoenix, United States
Suspendu

University of Arizona Health Sciences Center

Tucson, United States
Suspendu

University of Arkansas for Medical Sciences

Little Rock, United States
Terminé163 Centres d'Étude