None listed
Conditions
Brief summary
Cancer is not uncommon in women of reproductive age. Women diagnosed with cancer during their reproductive period are often concerned not only with the uncertainty of long-term survival, but also with the potential loss of fertility as a result of cancer treatment. A combination of gonadotrophin-releasing hormone (GnRH) analogue administrations with cyclophosphamide-based chemotherapy may provide protection to the woman's ovaries during treatment. We wished to determine this in a multi-center, open label controlled trial of 100 reproductive age women needing chemotherapy.
Interventions
As part of a multicenter randomized trial, participants will be stratified according to the timing of their first presentation(Women requiring early chemotherapy will be randomly allocated to receive either early chemotherapy alone (EC Control) or GnRH-ant (Cetrotide0.25 mg, cetrorelix, Merck Serono, Switzerland) and GnRH-ag (Decapeptyl CR, triptorelin 3.75 mg, Ferring, Switzerland) combination followed by chemotherapy (EC GnRH) when down-regulation (E2<50 pg/ml) is confirmed with discontinuatio
As part of a multicenter randomized trial, participants will be stratified according to the timing of their first presentation(Women requiring early chemotherapy will be randomly allocated to receive either early chemotherapy alone (EC Control) or GnRH-ant (Cetrotide0.25 mg, cetrorelix, Merck Serono, Switzerland) and GnRH-ag (Decapeptyl CR, triptorelin 3.75 mg, Ferring, Switzerland) combination followed by chemotherapy (EC GnRH) when down-regulation (E2<50 pg/ml) is confirmed with discontinuation of GnRH-ant and continuation of triptorelin every 4 weeks until end of chemotherapy When chemotherapy is planned to start later than 10 days, women will be randomized to receive either chemotherapy alone (DC Control) or GnRH-ag followed by chemotherapy (DC GnRH) after confirmation of down-regulation (E2<50 pg/ml) with continuation of agonist until end of chemotherapy. FAC regime will be used in all participants (IV 5-flourouracil (500\m2), adriamycin, (50mg\m2) and cyclophosphamide (500mg\m2) every 21 days for six cycle in absence of disease progression or toxicity. Adverse events will be assessed clinically and by means of hematologic and biochemical measurements. Lymph node dissection wil bel performed on a case-by-case basis. Regional adjuvant radiotherapy will be allowed.
Sponsors
Ass. Prof. Dr. Eman Elgindy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Women between 18 and 40 years old receiving cyclophosphamide-based chemotherapy for treatment of cancer with presence of both ovaries and absence of ovarian tumours or cysts over 40 mm in diameter demonstrated by transvaginal ultrasound
Exclusion criteria
Advanced stage disease or evidence of metastases; Cancer of the ovaries, uterus, or fallopian tubes; Women who previously received chemotherapy or abdominal/pelvic radiation or are planned to receive abdomino-pelvic radiation; Patients taking hormone therapy biologic therapy or corticosteroids; Women who are pregnant or nursing.
Outcome results
None listed