Prosthesis SurvivalPhase 2EC-0701NCT01918124
A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer
A Phase 2 study testing radiotherapy, Cisplatin and Cisplatin and Doxorubicin and Cyclophosphamide in people with Prosthesis Survival, run by Fan Ming at 1 site in China.
Trial summary
This phase II clinical trial was designed to assess the feasibility, safety, toxicity, recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Prosthesis Survival
- What is being tested?
- radiotherapy, Cisplatin and Cisplatin and Doxorubicin and Cyclophosphamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have had a hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) or modified radical hysterectomy or radical hysterectomy and bilateral salpingo-oophorectomy no more than 8 weeks prior to start of radiation therapy.
- Additional surgical staging procedures are permissible but not required.
- Risk factors: patients must fit one of the following:
- Pelvic lymph node metastases
- Paraaortic lymph node metastases
- Grade 3 with myometrial invasion >50%
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- With stromal invasion of cervix
- Known extrauterine disease (excluding second primary) confined to the pelvis.
- High risk pathological type include: uterine papillary serous carcinoma, clear cell carcinoma, squamous cell carcinoma, undifferentiated carcinoma,
- No known gross residual disease, or distant metastases.
- Eastern Cooperative Oncology Group (ECOG) score<=2; Age 18~75.
- White Blood Cell (WBC)≥4000/mm3, granulocytes ≥1500/mcl, platelets≥100,000/mcl.
- Acceptable hepatic and renal function: creatinine <=1.4 mg%, bilirubin and serum glutamate oxaloacetate transaminase (SGOT) <=2*normal.
- No medical contraindications to chemotherapy, or radiation therapy.
- Study-specific signed informed consent.
Who cannot join
- Prior pelvic radiation therapy.
- Positive peritoneal cytology only for stage IIIa (FIGO 1998).
- With history of other malignancies less than 5 years.
- With gross residual disease, or distant metastases.
- With endometrioid endometrial carcinoma and no risk factors:
- with myometrial invasion <50%
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- Grade 1~2, with myometrial invasion >50%
- With serious internal diseases which affect designed treatment
- With psychotic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Trial of Adjuvant Postoperative Irradiation Combined With Paclitaxel/Carboplatin(TP) or Cisplatin/Doxorubicin/Cyclophosphamide (CAP) Chemotherapy for Patients With High-risk Endometrial Cancer
This phase II clinical trial was designed to assess the feasibility, safety, toxicity, recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer.
- Conditions
- Prosthesis Survival
- Being tested
- radiotherapy, Cisplatin, Cisplatin and Doxorubicin and Cyclophosphamide, Paclitaxel and Carboplatin
- Keywords
- disease free survival, overall survival
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery.
CisplatinDrug
Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy.
Cisplatin and Doxorubicin and CyclophosphamideDrug
Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) chemotherapy given at 3 week intervals following completion of radiotherapy.
Paclitaxel and CarboplatinDrug
Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy combined with chemotherapy | Experimental | Arm Label: radiotherapy combined with chemotherapy:
Radiotherapy:
Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery.
Cisplatin:
Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy.
Cisplatin and Doxorubicin and Cyclophosphamide： Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) given at 3 week intervals following completion of radiotherapy.
Paclitaxel and Carboplatin： Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy. Receives: Radiation: radiotherapy; Drug: Cisplatin; Drug: Cisplatin and Doxorubicin and Cyclophosphamide; Drug: Paclitaxel and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival(DFS)
From date of randomization until the date of first documented progression, assessed up to 60 months.
Measured: From date of randomization until the date of first documented progression, assedded up to 60 months
Secondary outcomes (1)
Overall Survival (OS)
From date of randomization until the date of death from any cause, assessed up to 60 months.
Measured: From date of randomization until the date of death from any cause, assedded up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthesis SurvivalStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fan Ming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fan Ming, Fudan University
- Investigators
- Huaying Wang, Doctor, Study chair, Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918124
- Sponsor's protocol ID
- 070148-7
- Acronym
- EC-0701
- Status last verified
- Oct 2018
- First submitted
- 29 Jul 2013
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ren Y, Huang X, Shan B, Wu X, Huang X, Shi D, Wang H. Adjuvant concurrent chemoradiation followed by chemotherapy for high-risk endometrial cancer. Gynecol Oncol. 2016 Jan;140(1):58-63. doi: 10.1016/j.ygyno.2015.11.021. Epub 2015 Nov 24.
PubMed 26607778
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Adjuvant Postoperative Irradiation Combined With Paclitaxel/Carboplatin(TP) or Cisplatin/Doxorubicin/Cyclophosphamide (CAP) Chemotherapy for Patients With High-risk Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01918124
- Acronym / sponsor ID
- EC-0701 / 070148-7
- Conditions
- Prosthesis Survival
- Keywords
- disease free survival, overall survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fan MingUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 7 Aug 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 phase II clinical trial was designed to assess the feasibility, safety, toxicity, recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiotherapy combined with chemotherapy | Experimental | Radiation: radiotherapy, Drug: Cisplatin, Drug: Cisplatin and Doxorubicin and Cyclophosphamide, Drug: Paclitaxel and CarboplatinArm Label: radiotherapy combined with chemotherapy: Radiotherapy: Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery. Cisplatin: Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy. Cisplatin and Doxorubicin and Cyclophosphamide： Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) given at 3 week intervals following completion of radiotherapy. Paclitaxel and Carboplatin： Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have had a hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) or modified radical hysterectomy or radical hysterectomy and bilateral salpingo-oophorectomy no more than 8 weeks prior to start of radiation therapy.
- Additional surgical staging procedures are permissible but not required.
- Risk factors: patients must fit one of the following:
- No known gross residual disease, or distant metastases.
- Eastern Cooperative Oncology Group (ECOG) score<=2; Age 18~75.
Key exclusion criteria (9 listed)
- Prior pelvic radiation therapy.
- Positive peritoneal cytology only for stage IIIa (FIGO 1998).
- With history of other malignancies less than 5 years.
- With gross residual disease, or distant metastases.
- With endometrioid endometrial carcinoma and no risk factors:
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 |
|---|---|---|
| radiotherapyPelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery. | Radiation | radiotherapy combined with chemotherapy |
| CisplatinTwo courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy. | Drug | radiotherapy combined with chemotherapy |
| Cisplatin and Doxorubicin and CyclophosphamideFour courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) chemotherapy given at 3 week intervals following completion of radiotherapy. | Drug | radiotherapy combined with chemotherapy |
| Paclitaxel and CarboplatinOr four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy. | Drug | radiotherapy combined with chemotherapy |
Primary outcome
Disease Free Survival(DFS)
Time frame: From date of randomization until the date of first documented progression, assedded up to 60 months
From date of randomization until the date of first documented progression, assessed up to 60 months.
1 secondary outcome
Overall Survival (OS)
Time frame: From date of randomization until the date of death from any cause, assedded up to 60 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Derived from this study: PubMed 26607778Ren Y, Huang X, Shan B, Wu X, Huang X, Shi D, Wang H. Adjuvant concurrent chemoradiation followed by chemotherapy for high-risk endometrial cancer. Gynecol Oncol. 2016 Jan;140(1):58-63. doi: 10.1016/j.ygyno.2015.11.021. Epub 2015 Nov 24.
- Related InfoLink provided by the sponsor.
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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.
Huaying Wang, Doctor study chair
Shanghai Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiotherapy, Cisplatin and Cisplatin and Doxorubicin and Cyclophosphamide in people with Prosthesis Survival, run by Fan Ming 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 15 inclusion and 9 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: finished, as of the sponsor's last update on 12 Oct 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: From date of randomization until the date of first documented progression, assedded up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01918124, which also lists 1 linked publication.
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 12 Oct 2018.