Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer

Sponsor

Medical Research Council (Other)

Overall Status

Completed

CT.gov ID

NCT00003014

Collaborator

European Organisation for Research and Treatment of Cancer - EORTC (Other)

800

Enrollment

Locations

Duration (Months)

12.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Testicular Germ Cell Tumor	Drug: carboplatin Radiation: radiation therapy	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

Carboplatin in the Adjuvant Treatment of Stage I Seminoma: A Radomized Comparison of Single Agent Carboplatin With Radiotherapy in the Adjuvant Treatment of Stage I Seminoma of the Testis, Following Orchidectomy

Study Start Date :

Apr 1, 1998

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Porto Alegre Hospital	Porto Alegre	Rio Grande do Sul	Brazil	90035--003
2	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
3	Mount Sinai Hospital - Toronto	Toronto	Ontario	Canada	M5G 1X5
4	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
5	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
6	Maria Hospital	Helsinki		Finland	FIN-0-0180
7	Antoni van Leeuwenhoekhuis	Amsterdam		Netherlands	1066 CX
8	Norwegian Radium Hospital	Oslo		Norway	N-0310
9	Groote Schuur Hospital, Cape Town	Cape Town		South Africa	7925
10	Royal United Hospital	Bath	England	United Kingdom	BA1 3NG
11	University of Birmingham	Birmingham	England	United Kingdom	B15 2TT
12	Children's Hospital - Birmingham UK	Birmingham	England	United Kingdom	B16 8ET
13	Bradford Hospitals NHS Trust	Bradford	England	United Kingdom	BD9 6RJ
14	Royal Sussex County Hospital	Brighton	England	United Kingdom	BN2 5BE
15	Bristol Royal Hospital for Sick Children	Bristol	England	United Kingdom	BS2 8BJ
16	Bristol Haematology and Oncology Centre	Bristol	England	United Kingdom	BS2 8ED
17	Addenbrooke's NHS Trust	Cambridge	England	United Kingdom	CB2 2QQ
18	Kent and Canterbury Hospital	Canterbury	England	United Kingdom	CT2 7NR
19	Walsgrave Hospital	Coventry	England	United Kingdom	CV2 2DX
20	Derbyshire Royal Infirmary	Derby	England	United Kingdom	DE1 2QY
21	Derbyshire Children's Hospital	Derby	England	United Kingdom	DE1 3BA
22	Royal Devon and Exeter Hospital	Exeter	England	United Kingdom	EX2 5DW
23	Gloucester Royal NHS Trust - Glouchester Royal Hospital	Gloucester	England	United Kingdom	GL1 3NN
24	Royal Surrey County Hospital	Guildford	England	United Kingdom	GU2 5XX
25	Royal Free Hospital	Hampstead, London	England	United Kingdom	NW3 2QG
26	Huddersfield Royal Infirmary	Huddersfield, West Yorks	England	United Kingdom	HD3 3EA
27	Cookridge Hospital	Leeds	England	United Kingdom	LS16 6QB
28	St. James's Hospital	Leeds	England	United Kingdom	LS9 7TF
29	University Hospitals of Leicester	Leicester	England	United Kingdom	LE1 5WW
30	Saint Bartholomew's Hospital	London	England	United Kingdom	EC1A 7BE
31	St. Bartholomew's Hospital	London	England	United Kingdom	EC1A 7BE
32	Guy's and St. Thomas' Hospitals Trust	London	England	United Kingdom	SE1 7EH
33	Westminster Hospital	London	England	United Kingdom	SW1P 2AP
34	University College Hospital	London	England	United Kingdom	WC1E 6AU
35	Middlesex Hospital- Meyerstein Institute	London	England	United Kingdom	WIT 3AA
36	Manchester Children's Hospitals (NHS Trust)	Manchester	England	United Kingdom	M27 SHA
37	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England	United Kingdom	L63 4JY
38	South Tees Acute Hospitals NHS Trust	Middlesbrough, Cleveland	England	United Kingdom	TS4 3BW
39	Newcastle General Hospital	Newcastle Upon Tyne	England	United Kingdom	NE4 6BE
40	Newcastle Upon Tyne Hospitals NHS Trust - Freeman Hospital	Newcastle-Upon-Tyne	England	United Kingdom	NE7 7DN
41	Mount Vernon Hospital	Northwood	England	United Kingdom	HA6 2RN
42	Norfolk & Norwich Hospital	Norwich	England	United Kingdom	NR1 3SR
43	Oxford Radcliffe Hospital	Oxford	England	United Kingdom	0X3 9DU
44	Portsmouth Hospitals NHS Trust	Portsmouth	England	United Kingdom	P03 6AD
45	Children's Hospital - Sheffield	Sheffield	England	United Kingdom	S10 2TH
46	Weston Park Hospital	Sheffield	England	United Kingdom	S1O 2SJ
47	Royal South Hants Hospital	Southampton	England	United Kingdom	SO14 0YG
48	Southampton General Hospital	Southampton	England	United Kingdom	SO16 6YD
49	Royal Marsden Hospital	Sutton	England	United Kingdom	SM2 5PT
50	Princess Royal Hospital	Telford	England	United Kingdom	TF6 6TF
51	Walsall Manor Hospital	Walsall	England	United Kingdom	WS2 9PS
52	Southend NHS Trust Hospital	Westcliff-On-Sea	England	United Kingdom
53	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland	United Kingdom	BT12 6BE
54	Aberdeen Royal Infirmary	Aberdeen	Scotland	United Kingdom	AB25 2ZN
55	Ninewells Hospital and Medical School	Dundee	Scotland	United Kingdom	DD1 9SY
56	Western General Hospital	Edinburgh	Scotland	United Kingdom	EH4 9NQ
57	Royal Hospital for Sick Children	Edinburgh	Scotland	United Kingdom
58	Beatson Oncology Centre	Glasgow	Scotland	United Kingdom	G11 6NT
59	Royal Infirmary	Glasgow	Scotland	United Kingdom	G4 0SF
60	Ysbyty Gwynedd	Bangor	Wales	United Kingdom	LL57 2PW
61	Llandough Hospital	Penarth	Wales	United Kingdom	CF6 1XX
62	Royal Preston Hospital	Preston		United Kingdom	PR2 9HT