Brief Title
Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer
Official Title
A Multicenter Randomized Controlled Study of Modalities of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer
Brief Summary
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 Ⅲ 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.
Study Type
Interventional
Primary Outcome
Progress-free survival
Secondary Outcome
Overall survival
Condition
Endometrial Cancer
Intervention
sequential radiochemotherapy in a "sanwich" mode
Study Arms / Comparison Groups
sequential radiochemotherapy in a "sanwich" mode
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
654
Start Date
May 12, 2020
Completion Date
April 2027
Primary Completion Date
April 2025
Eligibility Criteria
Inclusion Criteria:
1. patients of primary treatment
2. All patients must have undertaken comprehensive staging operation（Surgery must have
included a hysterectomy and bilateral salpingooophorectomy and surgical staging).
3. Patients with endometrial adenocarcinoma confirmed by postoperative patholog.
4. All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009
staging criteria.
5. Entry into the study is limited to no more than 8 weeks from the date of surgery.
6. Patients with adequate organ function, reflected by the following parameters:
1. WBC ≥ Normal value of the institution;
2. Absolute neutrophil count (ANC) ≥ Normal value of the institution;
3. Platelet count ≥ 100,000/mcl;
4. SGOT, SGPT, and alkaline phosphatase ≤ 1.25 X upper limit of normal (ULN) ;
5. Bilirubin ≤ 1.5 X ULN;
6. Creatinine ≤ institutional ULN.
7. Patients with a Karnofsky score≥60.
8. The patients should voluntarily join the study, sign an approved informed consent with
good compliance and cooperation with the follow-up.
Exclusion Criteria:
1. Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or
endocrine therapy).
2. Patients with residual tumor after surgery.
3. Patients with other invasive malignancies.
4. Patients with contraindications of radiotherapy and chemotherapy (with a history of
myocardial infarction within 3 month, unstable angina pectoris or history of
uncontrolled arrhythmia s from the date of registration) and who cannot receive
postoperative adjuvant radiotherapy and chemotherapy.
5. Patients with an estimated survival of less than 6 months.
6. Those who are unable or unwilling to comply with the research requirements
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, +861088324381, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04453904
Organization ID
2020PHB013-01
Responsible Party
Sponsor
Study Sponsor
Peking University People's Hospital
Study Sponsor
, ,
Verification Date
June 2020