None listed
Conditions
Brief summary
This study compares radiation plus chemotherapy with radiation alone in treating women with endometrial cancer that is classified as high risk or advanced stage. Who is it for? You can join this study if you are a woman who has endometrial cancer that is classified as high risk or is at an advanced stage. Trial details Participants will be divided into two groups. Both groups will receive radiation treatment in the pelvic region, while one group will also receive chemotherapy at the same time as radiation, followed by adjuvant chemotherapy. The chemotherapy given at the same time as radiation treatment is called cisplatin and is administered by intravenous drip on days 1 and 22. The adjuvant chemotherapy is a combination of carboplatin and paclitaxel and is administered in 4 cycles at 3 week intervals. For the group receiving radiation and chemotherapy, the treatment extends over 5 months. For the group receiving radiation alone, treatment goes for 6 weeks. All participants are monitored for 10 years. The study aims to see whether combining chemotherapy with radiotherapy treatment, compared with radiotherapy alone, improves overall survival rates, and also looks at quality of life.
Interventions
External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions, 5 fractions a week; radiotherapy treatment time should be kept within 6 weeks) with concurrent chemotherapy (2 cycles (21 day cycles) of intravenous cisplatin 50mg/m2 on day 1 of each cycle) followed by adjuvant chemotherapy (4 cycles (21 day cycles) of intravenous carboplatin AUC 5 and paclitaxel 175mg/m2 on day 1 of each cycle). Treatment time for the experimental arm is approximately 5 months, dependent on treatment delays. Follo
External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions, 5 fractions a week; radiotherapy treatment time should be kept within 6 weeks) with concurrent chemotherapy (2 cycles (21 day cycles) of intravenous cisplatin 50mg/m2 on day 1 of each cycle) followed by adjuvant chemotherapy (4 cycles (21 day cycles) of intravenous carboplatin AUC 5 and paclitaxel 175mg/m2 on day 1 of each cycle). Treatment time for the experimental arm is approximately 5 months, dependent on treatment delays. Follow-up will end at 10 years post-randomisation.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed endometrial carcinoma, with one of the following postoperative International Federation of Gynecology and Obstetrics (FIGO) stages and grade: a. Stage IB grade 3 with documented Lymphatic Vascular Space Invasion (LVSI) b. Stage 1C grade 3 c. Stage II grade 3 d. Stage IIIA or IIIC (IIIA based on peritoneal cytology alone is only eligible if grade 3) e. Stage IB or IC, stage II or stage III with serous or clear cell histology 2. World Health Organisation (WHO) performance status zero to two 3. White Blood Cells (WBC) greater than or equal to 3.0 x 10^9/L 4. Platelets greater than or equal to 100 x 10^9/L 5. Bilirubin less than or equal to 1.5 x Upper Normalised Limit (UNL) 6. Aspartate Aminotransferase (ASAT)/Alanine Aminotreansferase (ALAT) less than or equal to 2.5 x UNL 7. Written informed consent
Exclusion criteria
1. Previous malignancy, except for basal cell carcinoma of the skin, less than ten years 2. Previous pelvic radiotherapy 3. Hormonal therapy or chemotherapy for this tumor 4. Macroscopic stage IIB for which Wertheim type hysterectomy 5. Prior diagnosis of Crohn's disease or ulcerative colitis 6. Residual macroscopic tumor after surgery 7. Creatinine clearance less than or equal to 60 ml/min (calculated according to Cockroft) or less than or equal to 50 ml/min (EthyleneDiamineTetraacetic Acid [EDTA] clearance, or measured creatinine clearance) 8. Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy 9. Peripheral Neuropathy more than or equal to grade two
Outcome results
None listed