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Randomized Study of Drainage of the Axilla After Lymph Node Dissection in Women With Stage I or II Breast Cancer

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

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

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.