Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

NCT04453904 | Recruiting DMC

• 1 other identifier: 2020PHB013-01
• Study Type: interventional
• Target: 654
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

radiochemotherapy; sanwich mode

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival

  From the date of randomization until the date of death from any cause, assessed up to 60 months

• adverse effect

  through study completion,an average of 1 year

• patient-reported Quality of Life

  3 months after treatment and 1 year after treatment

Study Arms (2)

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.

Other: sequential radiochemotherapy in a "sanwich" mode

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.

Other: sequential radiochemotherapy in a "sanwich" mode

Interventions

sequential radiochemotherapy in a "sanwich" mode OTHER

Patients will randomized into two different modalities of radiochemotherapy.

concurrent chemoradiotherapy followed by chemotherapy; sequential radiochemotherapy in a "sanwich" mode

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or endocrine therapy).
• Patients with residual tumor after surgery.
• 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.
• Patients with an estimated survival of less than 6 months.
• Those who are unable or unwilling to comply with the research requirements

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Jianliu Wang

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Guo Zhang, Ph.D

CONTACT

+861088324381; zhangguo-2005@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: July 1, 2020
• Study Start: May 12, 2020
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

CN (1)