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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003267 |
Purpose
RATIONALE: The use of pelvic drains may help to prevent complications following radical hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains during surgery is more effective than receiving no pelvic drains during surgery in patients with uterine, cervical, or vaginal cancer.
PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with uterine, cervical, or vaginal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer-Related Problem/Condition Cervical Cancer Endometrial Cancer Vaginal Cancer |
Procedure: infection prophylaxis and management Procedure: management of therapy complications Procedure: surgical procedure |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| Official Title: | A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND) |
| Estimated Enrollment: | 214 |
| Study Start Date: | February 1998 |
OBJECTIVES: I. Evaluate postoperative complications associated with the use or omission of pelvic drains following radical hysterectomy and node dissection that includes suturing of the vaginal cuff and no peritonealization.
OUTLINE: This is a randomized, two-arm study. All patients receive radical hysterectomy (Rutledge-Piver II-III type) and pelvic lymphadenectomy, without pelvic and parietal peritonealization, with suturing of the vaginal cuff and closure of fascia and cutaneous layers; lumboaortic node dissection is optional. Patients are randomized during surgery to one of two arms: those on arm I receive pelvic drains and those on arm II do not. Those in arm I have drains applied in the pelvis, and lymph is collected by vaginal and/or transabdominal drains located in both retroperitoneal fossa. Drains are removed when the loss is less than 50 mL in 24 hours. Patients in both arms are followed at 2-3 months and 12 months after surgery.
PROJECTED ACCRUAL: 214 patients will be accrued for this study within 2 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven cervical, vaginal, or endometrial carcinoma for which abdominal radical hysterectomy (Rutledge-Piver II or III type) and pelvic node dissection is indicated The following are excluded: Extensive intraoperative retroperitoneal blood loss (more than 3000 mL) Excessive postsurgical hemorrhage or oozing of the wound area requiring postoperative drainage Concurrent urinary or bowel injury/deviation or surgical procedures for urinary incontinence (Burch etc.) Application of prophylactic abdominal mesh for subsequent radiotherapy
PATIENT CHARACTERISTICS: Age: Not specified Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Contacts and Locations| Austria | |
| Kaiser Franz Josef Hospital | |
| Vienna (Wien), Austria, A-1100 | |
| Belgium | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| France | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Germany | |
| University Medical Center | |
| Freiburg, Germany, D-79106 | |
| Italy | |
| Azienda Ospedaliera Di Parma | |
| Parma, Italy, 43100 | |
| Instituto Scientifico H.S. Raffaele | |
| Milano (Milan), Italy, 20132 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Milano (Milan), Italy, 20133 | |
| Ospedale Civile | |
| Voghera (PV), Italy, 27058 | |
| Ospedale di Circolo e Fondazione Macchi | |
| Varese, Italy, 21100 | |
| Universita di Brescia | |
| Brescia, Italy, 25124 | |
| University and I.R.C.C.S. Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Netherlands | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3508 GA | |
| Antoni van Leeuwenhoekhuis | |
| Amsterdam, Netherlands, 1066 CX | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 ZA | |
| Medisch Spectrum Twente | |
| Enschede, Netherlands, 7500 KA | |
| Portugal | |
| Hospitais da Universidade de Coimbra (HUC) | |
| Coimbra, Portugal, 3049 | |
| Spain | |
| Instituto Valenciano De Oncologia | |
| Valencia, Spain, 46009 | |
| Study Chair: | Sergio L. Pecorelli, MD | Spedali Civili di Brescia |
More Information
| Study ID Numbers: | CDR0000066163, EORTC-55962 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003267 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I cervical cancer stage II cervical cancer stage I vaginal cancer stage II vaginal cancer |
stage I endometrial carcinoma stage II endometrial carcinoma infection perioperative/postoperative complications |
|
Genital Diseases, Female Vaginal Neoplasms Endometrial Neoplasms Postoperative Complications Vaginal Cancer Genital Neoplasms, Female |
Uterine Diseases Uterine Neoplasms Endometrial Cancer Vaginal Diseases Urogenital Neoplasms Carcinoma |
|
Genital Diseases, Female Vaginal Neoplasms Neoplasms Endometrial Neoplasms Neoplasms by Site |
Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Vaginal Diseases Urogenital Neoplasms |
