Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Closed 18 and over Other RMNHS-1489 EU-20004, NCT00005600

Objectives

1. Compare high vacuum drainage vs low vacuum drainage vs simple tube drainage in patients undergoing axillary surgery for stage I or II breast cancer.

Entry Criteria

Disease Characteristics:

• Diagnosis of resectable stage I or II breast cancer



• Planned primary surgery of level II or III axillary dissection in association with one of the following:
  • Wide local excision (may be done through separate incision)
  • No breast surgery
  • Bilateral surgery allowed



• No prior mastectomy



• No immediate breast reconstruction using implants, latissimus dorsi, or rectus abdominus myocutaneous flaps at primary operation



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics
• No prior axillary surgery

Patient Characteristics:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant

Expected Enrollment

A total of 200 patients will be accrued for this study.

Outline

This is a randomized study.

Patients undergo axillary dissection, then are randomized to one of three axillary drainage systems.

• Arm I: Patients receive high vacuum drainage.



• Arm II: Patients receive low vacuum drainage.



• Arm III: Patients receive simple tube drainage (no vacuum).

All drains are removed when daily volumes are below 30 mL or at 5 days after surgery, regardless of drain volume.

Patients are followed at day 10 and at 3 months.

Trial Contact Information

Trial Lead Organizations

Royal Marsden - London

Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng), Protocol chair		Ph: 44-20-7808-2783 Email: gerald.gui@rmh.nhs.uk

Registry Information
Official Title		Optimum Drainage of the Axilla after Lymph Node Dissection: A Randomized Prospective Study
Trial Start Date		1997-11-01
Registered in ClinicalTrials.gov		NCT00005600
Date Submitted to PDQ		2000-03-01
Information Last Verified		2005-12-05

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