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Spots Global Cancer Trial Database for Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer

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Trial Identification

Brief Title: Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer

Official Title: A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma

Study ID: NCT00005583

Study Description

Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy with chemotherapy is more effective than radiation therapy alone in treating high-risk endometrial cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk endometrial cancer.

Detailed Description: OBJECTIVES: * Compare relapse-free survival of patients with high-risk endometrial carcinoma treated in the adjuvant setting with either radiotherapy alone or radiotherapy and chemotherapy given sequentially. * Compare overall survival of this patient population treated with these 2 adjuvant regimens. * Evaluate the addition of chemotherapy to standard adjuvant radiotherapy, in terms of toxicity, in these patients. * Study whether the pattern of relapse in these patients is influenced by the addition of chemotherapy to adjuvant radiotherapy. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to center and histologic type (serous papillary and clear cell vs all other types). Patients are randomized to 1 of 2 treatment arms. All patients undergo hysterectomy with bilateral salpingooophorectomy and extirpation of macroscopic suspicious lymph nodes. * Arm I: Within 7 weeks after surgery, patients begin radiotherapy. * Arm II: Patients receive radiotherapy followed by or preceded by chemotherapy\*. Patients receive cisplatin IV over 60 minutes and doxorubicin or epirubicin IV over 10-20 minutes on day 1. Treament repeats every 21 days for 4 courses. NOTE: \*If radiotherapy is preceded by chemotherapy, radiotherapy begins within 4 weeks after chemotherapy. Patients are followed at 3 and 6 months and then every 6 months for 5 years. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Institut Jules Bordet, Brussels, , Belgium

Universitair Ziekenhuis Antwerpen, Edegem, , Belgium

Cazk Groeninghe - Campus Maria's Voorzienigheid, Kortrijk, , Belgium

U.Z. Gasthuisberg, Leuven, , Belgium

Centre Henri Becquerel, Rouen, , France

Coombe Women's Hospital, Dublin, , Ireland

St. James's Hospital, Dublin, , Ireland

Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples, , Italy

Azienda Ospedaliera Di Parma, Parma, , Italy

Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, , Italy

Ospedale di Circolo e Fondazione Macchi, Varese, , Italy

Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands

Medisch Spectrum Twente, Enschede, , Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen, Nijmegen, , Netherlands

Norwegian Radium Hospital, Oslo, , Norway

Medical University of Gdansk, Gdansk, , Poland

Hospitais da Universidade de Coimbra (HUC), Coimbra, , Portugal

Groote Schuur Hospital, Cape Town, , South Africa

Hospital Universitario San Carlos, Madrid, , Spain

Hospital Universitario Central de Asturias, Oviedo, , Spain

Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom

Centre for Cancer Research and Cell Biology at Belfast City Hospital, Belfast, Northern Ireland, United Kingdom

Western Infirmary, Glasgow, Scotland, United Kingdom

Contact Details

Name: Gunnar B. Kristensen, MD, PhD

Affiliation: Norwegian Radium Hospital

Role: STUDY_CHAIR

Name: Carlos F. de Oliveira, MD, PhD

Affiliation: Hospitais da Universidade de Coimbra (HUC)

Role:

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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