Endometrial CancerNCT04453904
Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer
A study testing sequential radiochemotherapy in a "sanwich" mode in people with Endometrial Cancer, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- sequential radiochemotherapy in a "sanwich" mode
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2020to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jianliu Wang
Beijing, Beijing Municipality, 100044
Jianliu Wang, Doctor, wangjianliu@pkuph.edu.cn
About this study
Official title: 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.
- Conditions
- Endometrial Cancer
- Being tested
- sequential radiochemotherapy in a "sanwich" mode
- Keywords
- radiochemotherapy, sanwich mode
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential radiochemotherapy in a "sanwich" modeOther
Patients will randomized into two different modalities of radiochemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: sequential radiochemotherapy in a "sanwich" mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From the date of randomization until the date of death from any cause, assessed up to 60 months
adverse effect
To compare the modalities with respect to acute and late adverse effects of therapy.
Measured: through study completion,an average of 1 year
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.
Measured: 3 months after treatment and 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start12 May 2020
- Primary completionApr 2025 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 654 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453904
- Sponsor's protocol ID
- 2020PHB013-01
- Status last verified
- Jun 2020
- First submitted
- 16 Mar 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Study of Modalities of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04453904
- Acronym / sponsor ID
- 2020PHB013-01
- Conditions
- Endometrial Cancer
- Keywords
- radiochemotherapy, sanwich mode
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 654 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential radiochemotherapy in a "sanwich" mode | Experimental | Other: sequential radiochemotherapy in a "sanwich" modeTwo 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. |
| concurrent chemoradiotherapy followed by chemotherapy | Active comparator | Other: sequential radiochemotherapy in a "sanwich" modeExternal 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sequential radiochemotherapy in a "sanwich" modePatients will randomized into two different modalities of radiochemotherapy. | Other | concurrent chemoradiotherapy followed by chemotherapy, sequential radiochemotherapy in a "sanwich" mode |
Primary outcome
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.
3 secondary outcomes
Overall survival
Time frame: 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
patient-reported Quality of Life
Time frame: 3 months after treatment and 1 year after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sequential radiochemotherapy in a "sanwich" mode in people with Endometrial Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo Zhang, Ph.D (+861088324381, zhangguo-2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.