Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

June 28, 2020 updated by: Peking University People's Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

654

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sequential radiochemotherapy in a "sanwich" mode
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
Patients will randomized into two different modalities of radiochemotherapy.
Active Comparator: concurrent chemoradiotherapy followed by chemotherapy
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
Patients will randomized into two different modalities of radiochemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress-free survival
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the date of randomization until the date of death from any cause, assessed up to 60 months
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
adverse effect
Time Frame: through study completion,an average of 1 year
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
Time Frame: 3 months after treatment and 1 year after treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2020

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2027

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

June 28, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 28, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PHB013-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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