Endometrial NeoplasmsPhase 3EC-01NCT01820858
The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
A Phase 3 study testing Paclitaxel, Paraplatin (Carboplatin Injection) and Pelvic Radiation in people with Endometrial Neoplasms, run by Ding Ma at 3 sites in China.
Trial summary
This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Endometrial Neoplasms
- What is being tested?
- Paclitaxel, Paraplatin (Carboplatin Injection) and Pelvic Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- Nov 2012to Dec 2026
- Phase
- Phase 3
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FIGO stage: Ⅰ, endometrial carcinoma;
- Female, Chinese women;
- Initial treatment is staging surgery;
- Pathological diagnosis: Endometrial adenocarcinoma;
- Pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement;
- No prior treatment;
- Provide written informed consent.
Who cannot join
- Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
- Family history of ovarian cancer;
- Suffering from other malignancies;
- Concurrently participating in other clinical trials;
- Unable or unwilling to sign informed consents;
- Unable or unwilling to abide by protocol.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310006
Qilu Hospital，Shandong University
Jinan, Shandong, 250012
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.
- Conditions
- Endometrial Neoplasms
- Being tested
- Paclitaxel, Paraplatin (Carboplatin Injection), Pelvic Radiation, Vaginal Brachytherapy 1, Vaginal brachytherapy 2
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
175 mg/m(2), intravenously (IV)
Paraplatin (Carboplatin Injection)Drug
AUC=5, IV
Pelvic RadiationRadiation
45-50 Gy
Vaginal Brachytherapy 1Radiation
5 Gy, 3 times
Vaginal brachytherapy 2Radiation
5 Gy, 2-4 times
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Chemotherapy | Experimental | Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary. Receives: Drug: Paclitaxel; Drug: Paraplatin (Carboplatin Injection) |
| Adjuvant Radiotherapy | Active comparator | 1. Histopathological grade G3 and <50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times;
2. Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy;
3. ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times. Receives: Radiation: Pelvic Radiation; Radiation: Vaginal Brachytherapy 1; Radiation: Vaginal brachytherapy 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Measured: 3-year DFS
Secondary outcomes (4)
Side effect of adjuvant chemotherapy
The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis)
Measured: 3-month，6-month，1-year and 3-year
Complications of radiotherapy
To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.
Measured: 3-month，6-month，1-year and 3-year
Quality of Life
Measured: 3-month，6-month，1-year and 3-year
Overall survival (OS)
Measured: 3-year OS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ding Ma
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University, Huazhong University of Science and Technology, Zhejiang University
- Responsible party
- Sponsor-investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Beihua Kong, MD, PhD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820858
- Sponsor's protocol ID
- 2012-GYN/EC-01
- Acronym
- EC-01
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2013
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT01820858
- Acronym / sponsor ID
- EC-01 / 2012-GYN/EC-01
- Conditions
- Endometrial Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ding MaUniversity, hospital or other
- Collaborators
- Shandong University, Huazhong University of Science and Technology, Zhejiang University
- Study start
- Nov 2012
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Mar 2013 (estimated)
- 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.
This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Chemotherapy | Experimental | Drug: Paclitaxel, Drug: Paraplatin (Carboplatin Injection)Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary. |
| Adjuvant Radiotherapy | Active comparator | Radiation: Pelvic Radiation, Radiation: Vaginal Brachytherapy 1, Radiation: Vaginal brachytherapy 21. Histopathological grade G3 and <50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times; 2. Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy; 3. ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- FIGO stage: Ⅰ, endometrial carcinoma;
- Female, Chinese women;
- Initial treatment is staging surgery;
- Pathological diagnosis: Endometrial adenocarcinoma;
- Pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement;
Key exclusion criteria (6 listed)
- Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
- Family history of ovarian cancer;
- Suffering from other malignancies;
- Concurrently participating in other clinical trials;
- Unable or unwilling to sign informed consents;
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 |
|---|---|---|
| Paclitaxel175 mg/m(2), intravenously (IV) | Drug | Adjuvant Chemotherapy |
| Paraplatin (Carboplatin Injection)AUC=5, IV | Drug | Adjuvant Chemotherapy |
| Pelvic Radiation45-50 Gy | Radiation | Adjuvant Radiotherapy |
| Vaginal Brachytherapy 15 Gy, 3 times | Radiation | Adjuvant Radiotherapy |
| Vaginal brachytherapy 25 Gy, 2-4 times | Radiation | Adjuvant Radiotherapy |
Primary outcome
Disease-free survival (DFS)
Time frame: 3-year DFS
4 secondary outcomes
Side effect of adjuvant chemotherapy
Time frame: 3-month，6-month，1-year and 3-year
Complications of radiotherapy
Time frame: 3-month，6-month，1-year and 3-year
Quality of Life
Time frame: 3-month，6-month，1-year and 3-year
Overall survival (OS)
Time frame: 3-year OS
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 2 Apr 2024.
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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. This study is not recruiting at the moment.
Beihua Kong, MD, PhD study chair
Qilu Hospital of Shandong University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel, Paraplatin (Carboplatin Injection) and Pelvic Radiation in people with Endometrial Neoplasms, run by Ding Ma at 3 sites 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 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 3-year DFS). 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 2 Apr 2024.