Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
01/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00002516

Protocol/serial number

ET 9302

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Bone cancer

Intervention

The trial is divided into two separate studies for standard risk and high risk patients. Following randomisation all patients receive induction chemotherapy with vincristine, adriamycin and ifosfamide alternating every 3 weeks with vincristine, actinomycin-D and ifosfamide (VAIA). A total of four courses, two of each drug combination.

A. STANDARD RISK PATIENTS: Following induction depending upon the initial randomisation patients are allocated to either:
1. Arm A: Chemotherapy with vincristine, adriamycin and cyclophosphamide alternating every 3 weeks with vincristine, actinomycin-D and cyclophosphamide (VACA). A total of ten courses, five of each drug combination.
2. Arm B: Chemotherapy with vincristine, adriamycin and ifosfamide alternating every 3 weeks with vincristine, actinomycin-D and ifosfamide (VAIA), a total of ten courses, five of each drug combination.

B. HIGH RISK PATIENTS: Following induction depending upon the initial randomisation patients are allocated to either:
1. Arm B: Chemotherapy, VAIA as described in Arm B for standard risk patients.
2. Arm C: Chemotherapy etoposide, vincristine, adriamycin and ifosfamide alternating every 3 weeks with etoposide, vincristine, actinomycin-D and ifosfamide (EVAIA). A total of ten courses, five of each drug combination.

Intervention type

Drug

Phase

Not Specified

Drug names

Cancer drugs

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1994

Overall trial end date

30/06/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Biopsy proven Ewing's sarcoma, atypical Ewing's sarcoma or peripheral neuroectodermal tumour
2. No previous radiotherapy, chemotherapy or surgery
3. No primary definitive local therapy
4. Aged < 35 years

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Patients with soft tissue Ewing's sarcoma or other small cell sarcomas are not eligible

Recruitment start date

01/01/1994

Recruitment end date

30/06/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Research organisation

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

European Community (BIOMED)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Deutsche Krebshilfe

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 1999 preliminary results in http://www.ncbi.nlm.nih.gov/pubmed/10472562
2. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12504050
3. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16137838
4. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18398583
5. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18802150

Publication citations

  1. Preliminary results

    Paulussen M, Ahrens S, Braun-Munzinger G, Craft AW, Dockhorn-Dworniczak B, Dörffel W, Dunst J, Fröhlich B, Göbel U, Häussler M, Klingebiel T, Koscielniak E, Mittler U, Rübe C, Winkelmann W, Voûte PA, Zoubek A, Jürgens H, [EICESS 92 (European Intergroup Cooperative Ewing's Sarcoma Study)-- preliminary results]., Klin Padiatr, 211, 4, 276-283, doi: 10.1055/s-2008-1043800.

  2. Results

    Schuck A, Ahrens S, Paulussen M, Kuhlen M, Könemann S, Rübe C, Winkelmann W, Kotz R, Dunst J, Willich N, Jürgens H, Local therapy in localized Ewing tumors: results of 1058 patients treated in the CESS 81, CESS 86, and EICESS 92 trials., Int. J. Radiat. Oncol. Biol. Phys., 2003, 55, 1, 168-177.

  3. Results

    Schuck A, Ahrens S, von Schorlemer I, Kuhlen M, Paulussen M, Hunold A, Gosheger G, Winkelmann W, Dunst J, Willich N, Jürgens H, Radiotherapy in Ewing tumors of the vertebrae: treatment results and local relapse analysis of the CESS 81/86 and EICESS 92 trials., Int. J. Radiat. Oncol. Biol. Phys., 2005, 63, 5, 1562-1567, doi: 10.1016/j.ijrobp.2005.05.036.

  4. Results

    Bölling T, Schuck A, Paulussen M, Dirksen U, Ranft A, Könemann S, Dunst J, Willich N, Jürgens H, Whole lung irradiation in patients with exclusively pulmonary metastases of Ewing tumors. Toxicity analysis and treatment results of the EICESS-92 trial., Strahlenther Onkol, 2008, 184, 4, 193-197, doi: 10.1007/s00066-008-1810-x.

  5. Results

    Paulussen M, Craft AW, Lewis I, Hackshaw A, Douglas C, Dunst J, Schuck A, Winkelmann W, Köhler G, Poremba C, Zoubek A, Ladenstein R, van den Berg H, Hunold A, Cassoni A, Spooner D, Grimer R, Whelan J, McTiernan A, Jürgens H, , Results of the EICESS-92 Study: two randomized trials of Ewing's sarcoma treatment--cyclophosphamide compared with ifosfamide in standard-risk patients and assessment of benefit of etoposide added to standard treatment in high-risk patients., J. Clin. Oncol., 2008, 26, 27, 4385-4393, doi: 10.1200/JCO.2008.16.5720.

Additional files

Editorial Notes