Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

A Multicenter Randomized Controlled Study of Modalities of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04453904
• Other study ID #: 2020PHB013-01
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: April 2027

Study information

• Verified date: June 2020
• Source: Peking University People's Hospital
• Contact: Guo Zhang, Ph.D
• Phone: +861088324381
• Email: zhangguo-2005[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 654
• Est. completion date: April 2027
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Other:
• sequential radiochemotherapy in a "sanwich" mode
Patients will randomized into two different modalities of radiochemotherapy.

Locations

Country	Name	City	State
China	Jianliu Wang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	From the date of randomization until the date of death from any cause, assessed up to 60 months
Secondary	adverse effect	To compare the modalities with respect to acute and late adverse effects of therapy.	through study completion,an average of 1 year
Secondary	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