|Phase III||Treatment||Active||Not specified||Other||CDR0000521447; P06.031|
CKTO-2006-04, ISRCTN14387080, P06.031-PORTEC-3, 2007-004917-33, CKTO-PORTEC-3, EU-20664, NCT00411138
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving chemotherapy together with radiation therapy is more effective than giving radiation therapy alone in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy and radiation therapy to see how well they work compared with radiation therapy alone in treating patients with high-risk, stage I, stage II, or stage III endometrial cancer.
Further Study Information
- Compare the overall survival and failure-free survival of patients with high-risk stage IB-III endometrial carcinoma treated with concurrent chemoradiotherapy followed by adjuvant chemotherapy vs pelvic radiotherapy alone.
- Compare the rates of pelvic and distant recurrence, severe (grades 3 and 4) treatment-related toxicity, and quality of life of patients treated with these regimens.
This is a multicenter, prospective, open-label, randomized, controlled study. Patients are stratified according to participating group (DGOG vs UK NCRI vs NCIC CTG vs MaNGO vs Unicancer), type of surgery (total abdominal hysterectomy and bilateral salpingo-oophorectomy [TAH-BSO] vs TAH-BSO plus lymphadenectomy vs laparoscopic hysterectomy [TLH-BSO] vs TLH-BSO plus lymphadenectomy), stage (IA vs IB vs II vs III), and histological type (endometrioid carcinoma vs serous or clear cell carcinoma). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive external-beam pelvic radiotherapy 5 days a week for up to 6 weeks, combined with cisplatin IV days 1 and 22. Patients with cervical involvement undergo vaginal brachytherapy boost. At least 3 weeks after completion of chemoradiotherapy, patients undergo adjuvant chemotherapy comprising paclitaxel IV and carboplatin IV on day 1. Adjuvant chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo external-beam pelvic radiotherapy (and vaginal brachytherapy alone in case of cervical involvement) as in arm I.
Quality of life is assessed at baseline, completion of radiotherapy, completion of chemotherapy, at 6 months, and then once a year for 5 years.
After completion of study therapy, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study.
- Histologically confirmed endometrial carcinoma, with one of the following postoperative FIGO 2009 stages and grade:
1. stage IA with invasion, grade 3 with documented LVSI
2. stage IB grade 3
3. stage II
4. stage IIIA or IIIC; or IIIB if parametrial invasion only
5. stage IA (with invasion), IB, II, or III with serous or clear cell histology
- WHO-performance status 0-2
- WBC ≥ 3.0 x 109/L.
- Platelets ≥ 100 x 109/L.
- Bilirubin ≤ 1.5 x UNL
- ASAT/ALAT ≤ 2.5 x UNL
- Written informed consent
- Uterine sarcoma (including carcinosarcoma)
- Previous malignancy (except for non-melanomatous skin cancer) < 10 yrs
- Previous pelvic radiotherapy
- Hormonal therapy or chemotherapy for this tumor
- Macroscopic stage II for which Wertheim type hysterectomy (eligible if stage II grade 3 or stage III at pathology)
- Prior diagnosis of Crohn's disease or ulcerative colitis
- Residual macroscopic tumor after surgery
- Creatinine clearance ≤ 60 ml/min (Cockroft) or ≤ 50 ml/min (EDTA clearance, or measured creatinine clearance)
- Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy
- Peripheral Neuropathy > or = grade 2
- Hearing impairment > or = grade 3, or born deaf
Trial Lead Organizations/Sponsors
Leiden University Medical CenterCancer Research UK
Australia New Zealand Gynaecological Oncology Trials Group
NCIC-Clinical Trials Group
Mario Negri Institute for Pharmacological Research
Federation Nationale des Centres de Lutte Contre le Cancer
|Carien L. Creutzberg, MD, PhD||Study Chair|
|Carien Creutzberg, MD PhD||Ph: +31 71 526 5120|
|Leiden University Medical Center|
|Carien L. Creutzberg, MD, PhD||Ph: 31-71-526-5120|
|Karen W. Verhoeven-Adema||Ph: +31-71-526-3052|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00411138
ClinicalTrials.gov processed this data on October 17, 2013
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