Combination Chemotherapy Followed By Surgery With or Without Radiation Therapy in Treating Young Patients With Stage II or Stage III Neuroblastoma

Sponsor

Children's Cancer and Leukaemia Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00276731

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain. It is not yet know whether combination chemotherapy followed by surgery alone is more effective than combination chemotherapy followed by surgery and radiation therapy in treating neuroblastoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by surgery to see how well it works compared to combination chemotherapy followed by surgery and radiation therapy in treating young patients with stage II or stage III neuroblastoma.

Condition or Disease	Intervention/Treatment	Phase
Neuroblastoma	Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase 3

Detailed Description

OBJECTIVES:

Compare the local control and event-free and overall survival of young patients with stage IIB and III neuroblastoma treated with neoadjuvant combination chemotherapy followed by surgery with vs without radiotherapy.
Determine the toxic effects of these regimen in these patients.

OUTLINE: This is a multicenter, randomized study.

Induction combination chemotherapy: Patients receive vincristine IV and cyclophosphamide IV on day 1. Patients also receive cisplatin IV continuously over 24 hours on day 1 and etoposide IV over 4 hours on day 2 during courses 1, 3, and 5 and carboplatin IV over 1 hour and etoposide IV over 4 hours on day 1 during courses 2 and 4. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to surgery unless complete resection was done during initial staging and complete response was maintained.
Surgery: Patients undergo biopsy or surgical resection of the tumor 2-3 weeks after completion of induction combination chemotherapy.
Post-surgical treatment: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive two additional courses of combination chemotherapy comprising vincristine, cisplatin, etoposide, and cyclophosphamide in course 6 and vincristine, carboplatin, etoposide, and cyclophosphamide in course 7.
Arm II: Patients undergo radiotherapy 2-4 weeks after surgery. Beginning 3 weeks after completion of radiotherapy, patients receive chemotherapy as in arm I After completion of study treatment, patients are evaluated periodically.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

Randomized Study of Radiotherapy in Patients With Stage 2B/3 (INSS) Neuroblastoma in Children Over 1 Year of Age

Study Start Date :

Mar 1, 1995

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed stage IIB or III neuroblastoma
No n-myc amplification

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

No prior chemotherapy or radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Our Lady's Hospital for Sick Children	Dublin		Ireland	12
2	Birmingham Children's Hospital	Birmingham	England	United Kingdom	B4 6NH
3	Institute of Child Health at University of Bristol	Bristol	England	United Kingdom	BS2 8AE
4	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England	United Kingdom	CB2 2QQ
5	Leeds Cancer Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS9 7TF
6	Leicester Royal Infirmary	Leicester	England	United Kingdom	LE1 5WW
7	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England	United Kingdom	L12 2AP
8	Royal London Hospital	London	England	United Kingdom	E1 1BB
9	Great Ormond Street Hospital for Children NHS Trust	London	England	United Kingdom	WC1N 3JH
10	Central Manchester and Manchester Children's University Hospitals NHS Trust	Manchester	England	United Kingdom	M27 4HA
11	Sir James Spence Institute of Child Health	Newcastle-Upon-Tyne	England	United Kingdom	NE1 4LP
12	Queen's Medical Centre	Nottingham	England	United Kingdom	NG7 2UH
13	Oxford Radcliffe Hospital	Oxford	England	United Kingdom	0X3 9DU
14	Children's Hospital - Sheffield	Sheffield	England	United Kingdom	S10 2TH
15	Southampton General Hospital	Southampton	England	United Kingdom	SO16 6YD
16	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England	United Kingdom	SM2 5PT
17	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland	United Kingdom	BT12 6BE
18	Royal Aberdeen Children's Hospital	Aberdeen	Scotland	United Kingdom	AB25 2ZG
19	Royal Hospital for Sick Children	Edinburgh	Scotland	United Kingdom	EH9 1LF
20	Beatson Oncology Centre	Glasgow	Scotland	United Kingdom	G11 6NT
21	Royal Hospital for Sick Children	Glasgow	Scotland	United Kingdom	G3 8SJ
22	Childrens Hospital for Wales	Cardiff	Wales	United Kingdom	CF14 4XW

Sponsors and Collaborators

Children's Cancer and Leukaemia Group

Investigators

Study Chair: Ann Barrett, University of Glasgow
: S. J. Keith Holmes, DO, St. George's Hospital
: Janice A. Kohler, MD, FRCP, University Hospital Southampton NHS Foundation Trust
: Andrew David J. Pearson, MD, FRCP, DCh, University of Newcastle Upon-Tyne
: Jack van Hoff, MD, Yale University
: Robert P. Castleberry, MD, University of Alabama at Birmingham
: Kevin Murray, MD, Mercy Regional Cancer Center at Mercy Medical Center