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Sponsored by: |
Queensland Centre for Gynaecological Cancer |
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Information provided by: | Queensland Centre for Gynaecological Cancer |
ClinicalTrials.gov Identifier: | NCT00147680 |
This study will be an open, non-randomised, clinical phase 2 trial, which will involve 30 women diagnosed with uterine papillary serous cancer. The researchers will investigate the effect of four cycles of paclitaxel/carboplatin, followed by whole pelvic external beam radiotherapy to a standard pelvis field (50.4 Gy) with or without a para-aortic boost with respect to the safety and efficacy of treatment, and patterns of recurrence.
Condition | Intervention | Phase |
---|---|---|
Uterine Cancer |
Drug: Paclitaxel, Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Non-Randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | September 2004 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Trial Objectives:
Treatment
Surgery: Total abdominal hysterectomy, bilateral salpingo-oophorectomy, +/- pelvic and aortic node sampling, omentectomy, peritoneal cytology.
Chemotherapy: Chemotherapy commences at the surgeon's and the medical oncologist's discretion and the time between surgery and start of chemotherapy will be recorded. One treatment cycle consists of 3 weeks.
Paclitaxel and Carboplatin will be administered as follows:
Day 1:
Day 22: Repeat the cycle. This is Day 1 of the second cycle.
Day 43: Repeat the cycle. This is Day 1 of the third cycle.
Day 64: Repeat the cycle. This is Day 1 of the fourth cycle.
Day 85: After the fourth cycle of chemotherapy patients
Patients with stage 4 disease will continue with chemotherapy for a total of 6 cycles.
Patients with surgical stage 1b to 3c disease will receive whole pelvis external beam radiotherapy (50.4 Gy RD over 5 and a half weeks +/- paraaortic boost +/- vaginal vault brachytherapy boost). Radiotherapy will start 4 to 6 weeks after commencement of chemotherapy when the haematological count has recovered.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, Queensland | |
Mater Adult Public Hospital | |
South Brisbane, Queensland, Australia, 4101 | |
QCGC, Royal Brisbane and Women's Hospital | |
Herston, Queensland, Australia, 4029 |
Principal Investigator: | Andreas Obermair | QCGC |
Study ID Numbers: | UPSC - 001 |
Study First Received: | September 6, 2005 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00147680 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Uterine Papillary Serous Carcinoma (UPSC) |
Genital Diseases, Female Cystadenocarcinoma, Serous Paclitaxel Genital Neoplasms, Female Uterine Diseases |
Uterine Neoplasms Urogenital Neoplasms Carboplatin Carcinoma |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |