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Endometrial cancer is the most common gynecological malignancy affecting women's health. About 15% of the patients will have local late disease (stage III) with high risk of recurrence and tumor related mortality. There is a consensus that adjuvant radiochemotherapy is needed for stage â…¢ endometrial cancer, but the best modality of radiochemotherapy is still uncertain. The retrospective data of our center showed that the sequential radiochemotherapy of "chemotherapy-radiotherapy-chemotherapy" in the "sanwich" mode could improve the survival outcome in patients with advanced endometrial cancer. A multicenter, prospective, randomized controlled study to compare the "sanwich" mode of radiochemotherapy and the "concurrent chemoradiotherapy followed by chemotherapy" mode will be carried out to determine the better modality of radiochemotherapy in stage III endometrial adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequential radiochemotherapy in a "sanwich" mode | Experimental | Two courses of TC regimen chemotherapy (paclitaxel 135-175mg / m2; carboplatin AUC = 5; once every 21 days) will be given first, followed by external pelvic radiation (± vaginal brachytherapy), and then four courses of the same regime consolidation chemotherapy. |
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| concurrent chemoradiotherapy followed by chemotherapy | Active Comparator | External pelvic radiation (± vaginal brachytherapy) will be given after operation. On the first day and the 29th day of radiotherapy, concurrent intravenous cisplatin (50mg/m2) will be given. After the concurrent radiochemotherapy, four courses of TC regimen (paclitaxel 135-175mg / m2; carboplatin AUC = 5; once every 21 days) chemotherapy will be given. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sequential radiochemotherapy in a "sanwich" mode | Other | Patients will randomized into two different modalities of radiochemotherapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival | To determine if treatment with radiochemotherapy in "sanwich" mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of recurrence or death (i.e., increases disease-free survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma. | From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | To determine if treatment with radiochemotherapy in "sanwich" mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of death (i.e., increases survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma. |
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Inclusion Criteria:
patients of primary treatment
All patients must have undertaken comprehensive staging operation(Surgery must have included a hysterectomy and bilateral salpingooophorectomy and surgical staging).
Patients with endometrial adenocarcinoma confirmed by postoperative patholog.
All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009 staging criteria.
Entry into the study is limited to no more than 8 weeks from the date of surgery.
Patients with adequate organ function, reflected by the following parameters:
Patients with a Karnofsky score≥60.
The patients should voluntarily join the study, sign an approved informed consent with good compliance and cooperation with the follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo Zhang, Ph.D | Contact | +861088324381 | zhangguo-2005@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jianliu Wang | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| From the date of randomization until the date of death from any cause, assessed up to 60 months |
| adverse effect | To compare the modalities with respect to acute and late adverse effects of therapy. | through study completion,an average of 1 year |
| patient-reported Quality of Life | To determine the impact on patient-reported Quality of Life (using the questionnaire of combining the items from FACT-G, FACT/GOG-NTX-4 subscale (4 items) and items C3 and C5 from the FACT-C)during and following treatment for up to 1 year with the two treatment regimens. | 3 months after treatment and 1 year after treatment |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |