NCT04453904Recruiting
Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer
A Multicenter Randomized Controlled Study of Modalities of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 1 Jul 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 654 (estimated)
- First submitted
- 16 Mar 2020
- Start date
- 12 May 2020
- Primary completion date
- Apr 2025
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Endometrial cancer, Childhood cancers
- NCT number
- NCT04453904
What you commit to
- Study type: Interventional
- Planned participants: 654
- From 12 May 2020 to the primary completion date, Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or endocrine therapy).
- Patients with residual tumor after surgery.
Other illness
- Patients with other invasive malignancies.
- 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.
Other
- Patients with an estimated survival of less than 6 months.
- Those who are unable or unwilling to comply with the research requirements
Who the study is looking for
- 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:
- WBC ≥ Normal value of the institution;
- Absolute neutrophil count (ANC) ≥ Normal value of the institution;
- Platelet count ≥ 100,000/mcl;
- SGOT, SGPT, and alkaline phosphatase ≤ 1.25 X upper limit of normal (ULN) ;
- Bilirubin ≤ 1.5 X ULN;
- Creatinine ≤ institutional ULN.
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jianliu Wang Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.