Endometrial Clear Cell AdenocarcinomaPhase 3NCT02501954
Trial of Cisplatin Plus Radiation Followed by Carbo and Taxol Vs. Sandwich Therapy of Carbo and Taxol Followed Radiation Then Further Carbo and Taxol
A Phase 3 study testing Cisplatin, Carboplatin and Paclitaxel in people with Endometrial Clear Cell Adenocarcinoma and Endometrial Serous Adenocarcinoma, run by Women's Cancer Care Associates, LLC at 7 sites in 2 countries.
Trial summary
To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage IIIA Uterine Corpus Cancer
- What is being tested?
- Cisplatin, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Mar 2015to Nov 2023
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with Surgical Stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria, including clear cell and serous papillary and undifferentiated carcinomas.
- Surgical Stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement.
- Surgical Stage IVA includes patients with bladder or bowel mucosal involvement, but no spread outside the pelvis.
- Patients with FIGO 2009 surgical Stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology.
- Surgery must have included a hysterectomy and bilateral salpingooophorectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional.
- Patients with a GOG Performance Status of 0, 1, or 2.
Show all 10Show fewer
- Patients with adequate organ function, reflected by the following parameters:
- WBC ≥ 3000/mcl Absolute neutrophil count (ANC) ≥ 1500/mcl Platelet count ≥ 100,000/mcl SGOT, SGPT, and alkaline phosphatase ≤ 2.5 X upper limit of normal (ULN) Bilirubin ≤ 1.5 X ULN Creatinine ≤ institutional ULN
- Patients must be 18 years of age or older.
- Entry into the study is limited to no more than 8 weeks from the date of surgery.
Who cannot join
- Patients with carcinosarcoma.
- Patients with recurrent endometrial cancer.
- Patients with residual tumor after surgery (any single site) exceeding 1 cm in maximum dimension.
- Patients who have had pelvic or abdominal radiation therapy.
- Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma.
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
Show all 12Show fewer
- Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy.
- Patients with an estimated survival of less than three months.
- Patients with FIGO 2009 Stage IVB endometrial cancer.
- Patients with parenchymal liver metastases.
- Patients who have received prior chemotherapy for endometrial cancer.
- Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Women's Cancer Care Associates, LLC
Albany, New York, 12208
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
The Ohio State University
Columbus, Ohio, 43210
Gunderson Lutheran Medical Foundation
La Crosse, Wisconsin, 54601
Atlantic Health
Morristown, New Jersey, 07960
Munson Health Care
Traverse City, Michigan, 49684
About this study
Official title: Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Sandwich Therapy of Carboplatin and Paclitaxel Followed by Tumor Volume Directed Irradiation Then Further Carboplatin and Paclitaxel
To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy.
Read the detailed description
To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence (increases recurrence-free survival) when compared to sandwich therapy (control arm).
To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (increases survival) when compared to sandwich therapy (control arm).
To compare the regimens with respect to tolerability and acute and late adverse effects of therapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol
Given IV
CarboplatinDrug
Also called Paraplatin
Given IV
PaclitaxelDrug
Also called Taxol
Given IV
Radiation TherapyRadiation
Also called RT, Irradiation
Undergo Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Regimen I | Experimental | Cisplatin 50 mg/m2 IV Days 1 and 29 plus Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy |
| Regimen II | Active comparator | Carboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam.
Measured: From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years
Secondary outcomes (1)
Overall survival (OS)
OS assessed by the contact with patient in person or by telephone
Measured: from study entry to death or date of last contact, assessed up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2023
- Study completionNov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Clear Cell AdenocarcinomaStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's Cancer Care Associates, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce N. Barlin, MD, Women's Cancer Care Associates, LLC
- Investigators
- Joyce N Barlin, MD, Principal investigator, Women's Cancer Care Associates, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501954
- Sponsor's protocol ID
- 15-07
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2015
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Sandwich Therapy of Carboplatin and Paclitaxel Followed by Tumor Volume Directed Irradiation Then Further Carboplatin and Paclitaxel
- ClinicalTrials.gov ID
- NCT02501954
- Acronym / sponsor ID
- 15-07
- Conditions
- Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage IIIA Uterine Corpus Cancer, Stage IIIB Uterine Corpus Cancer, Stage IIIC Uterine Corpus Cancer, Stage IVA Uterine Corpus Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Women's Cancer Care Associates, LLCUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Nov 2023 (actual)
- Study completion
- Nov 2023 (actual)
- First posted
- 17 Jul 2015 (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.
To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy.
Detailed description
To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence (increases recurrence-free survival) when compared to sandwich therapy (control arm).
To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (increases survival) when compared to sandwich therapy (control arm).
To compare the regimens with respect to tolerability and acute and late adverse effects of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen I | Experimental | Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel, Radiation: Radiation TherapyCisplatin 50 mg/m2 IV Days 1 and 29 plus Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles |
| Regimen II | Active comparator | Drug: Carboplatin, Drug: Paclitaxel, Radiation: Radiation TherapyCarboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All patients with Surgical Stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria, including clear cell and serous papillary and undifferentiated carcinomas.
- Surgical Stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement.
- Surgical Stage IVA includes patients with bladder or bowel mucosal involvement, but no spread outside the pelvis.
- Patients with FIGO 2009 surgical Stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology.
- Surgery must have included a hysterectomy and bilateral salpingooophorectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional.
Key exclusion criteria (12 listed)
- Patients with carcinosarcoma.
- Patients with recurrent endometrial cancer.
- Patients with residual tumor after surgery (any single site) exceeding 1 cm in maximum dimension.
- Patients who have had pelvic or abdominal radiation therapy.
- Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma.
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 |
|---|---|---|
| CisplatinAlso: PlatinolGiven IV | Drug | Regimen I |
| CarboplatinAlso: ParaplatinGiven IV | Drug | Regimen I, Regimen II |
| PaclitaxelAlso: TaxolGiven IV | Drug | Regimen I, Regimen II |
| Radiation TherapyAlso: RT, IrradiationUndergo Radiation Therapy | Radiation | Regimen I, Regimen II |
Primary outcome
Recurrence-free survival (RFS)
Time frame: From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years
RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam.
1 secondary outcome
Overall survival (OS)
Time frame: from study entry to death or date of last contact, assessed up to 8 years
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 23 Jul 2024.
Related trials for Endometrial Clear Cell Adenocarcinoma
RecruitingPhase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma
RecruitingPhase 1
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
Solid Tumor, Adult, Metastatic Solid Tumor
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced Cancer
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.
Joyce N Barlin, MD principal investigator
Women's Cancer Care Associates, LLC
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin, Carboplatin and Paclitaxel in people with Endometrial Clear Cell Adenocarcinoma and Endometrial Serous Adenocarcinoma, run by Women's Cancer Care Associates, LLC at 7 sites in 2 countries.
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 10 inclusion and 12 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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?
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?
Recurrence-free survival (RFS) (time frame: From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years). 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 23 Jul 2024.