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Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sequential radiochemotherapy in a "sanwich" mode
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring radiochemotherapy, sanwich mode

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jianliu WangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sequential radiochemotherapy in a "sanwich" mode

concurrent chemoradiotherapy followed by chemotherapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
adverse effect
To compare the modalities with respect to acute and late adverse effects of therapy.
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.

Full Information

First Posted
March 16, 2020
Last Updated
June 28, 2020
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04453904
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
radiochemotherapy, sanwich mode

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
654 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sequential radiochemotherapy in a "sanwich" mode
Arm Type
Experimental
Arm 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.
Arm Title
concurrent chemoradiotherapy followed by chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
sequential radiochemotherapy in a "sanwich" mode
Intervention Description
Patients will randomized into two different modalities of radiochemotherapy.
Primary Outcome Measure Information:
Title
Progress-free survival
Description
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.
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
Secondary Outcome Measure Information:
Title
Overall survival
Description
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.
Time Frame
From the date of randomization until the date of death from any cause, assessed up to 60 months
Title
adverse effect
Description
To compare the modalities with respect to acute and late adverse effects of therapy.
Time Frame
through study completion,an average of 1 year
Title
patient-reported Quality of Life
Description
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.
Time Frame
3 months after treatment and 1 year after treatment

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo Zhang, Ph.D
Phone
+861088324381
Email
zhangguo-2005@163.com
Facility Information:
Facility Name
Jianliu Wang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianliu Wang, Doctor
Email
wangjianliu@pkuph.edu.cn

12. IPD Sharing Statement

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Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

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