Radiation Therapy Compared With Chemotherapy in Treating... | NCT00003014

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1998

Primary Completion Date

Not provided

Completion Date

Jul 2005Actual

First Submitted Date

Nov 1, 1999

First Submission Date that Met QC Criteria

Mar 11, 2004

First Posted Date

Mar 12, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2013

Last Update Posted Date

Dec 4, 2013Estimated

Name	Class
European Organisation for Research and Treatment of Cancer - EORTC	NETWORK

Description Module

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective than radiation therapy for testicular cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with that of radiation therapy in treating patients who have stage I testicular cancer.

Detailed Description

OBJECTIVES: I. Compare relapse rates in patients with stage I testicular seminoma treated with adjuvant radiotherapy vs carboplatin. II. Compare quality of life of patients before and after treatment with these regimens. III. Compare the acute and intermediate (1-2 year) side effects of these regimens in these patients. IV. Determine the incidence of late side effects (such as bowel dysfunction) of treatment and second malignancies in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive a single dose of carboplatin IV. Arm II: Patients undergo radiotherapy once daily, 5 days a week. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study within 4 years.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage I seminomatous germ cell tumor of the testis categorized as either "classical" or "anaplastic"

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.4 mg/dL Other: No concurrent or previously treated malignancy except successfully treated nonmelanoma skin cancer No medical condition or other factor that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No more than 8 weeks since prior orchidectomy Prior inguino-pelvic or scrotal surgery allowed Must be treated with "dog-leg" field if randomized to radiotherapy If prior vasectomy, choice of fields is at the discretion of the clinician

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Von Der Maase, MD	Aarhus Universitetshospital - Aarhus Sygehus	Study Chair
R. T. Oliver, MD	St. Bartholomew's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Porto Alegre Hospital		Porto Alegre	Rio Grande do Sul	90035--003	Brazil
Cancer Care Ontario-London Regional Cancer Centre

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21212385	Background	Mead GM, Fossa SD, Oliver RT, Joffe JK, Huddart RA, Roberts JT, Pollock P, Gabe R, Stenning SP; MRC/EORTC seminoma trial collaborators. Randomized trials in 2466 patients with stage I seminoma: patterns of relapse and follow-up. J Natl Cancer Inst. 2011 Feb 2;103(3):241-9. doi: 10.1093/jnci/djq525. Epub 2011 Jan 6.
16039331	Result

ID	Type	Description	Link
MRC-TE19
EORTC-30982
EU-97003

ID	Term
C563236	Testicular Germ Cell Tumor
D013736	Testicular Neoplasms
D018239	Seminoma

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D004700	Endocrine System Diseases
D013733	Testicular Diseases
D006058	Gonadal Disorders
D018237	Germinoma
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

ID	Term
D016190	Carboplatin
D011878	Radiotherapy

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D013812	Therapeutics