Endometrial AdenocarcinomaPhase 3NCT00006011
Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
A Phase 3 study testing Doxorubicin Hydrochloride, Cisplatin and Filgrastim in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 1 site in United States.
Trial summary
Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma
- What is being tested?
- Doxorubicin Hydrochloride, Cisplatin and Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to Mar 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed advanced endometrial carcinoma with any histology, including:
- Clear cell and serous papillary carcinoma
- Surgical stage III disease, including:
- Positive adnexa
- Tumor invading the serosa
- Positive pelvic and/or paraaortic nodes
Show all 33Show fewer
- Involvement of bowel mucosa
- Intraabdominal metastases
- Positive pelvic washings
- Vaginal involvement within the radiation port
- Must have had prior surgery, including hysterectomy and bilateral salpingo-oophorectomy
- Tumor maximally debulked to a maximum residual diameter of no greater than 2 cm
- Paraaortic lymph node sampling allowed
- If positive, must have negative chest CT scan
- No recurrent disease
- No parenchymal liver metastases
- No disease outside the abdomen
- Performance status - GOG 0-2
- At least 3 months
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times normal
- SGOT/SGPT no greater than 3 times normal
- Alkaline phosphatase no greater than 3 times normal
- Creatinine no greater than 1.6 mg/dL
- LVEF at least 50% within 6 months of study entry
- No other prior or concurrent malignancy within the past 5 years except adequately treated nonmelanoma skin cancer
- No serious comorbid illness that would preclude study participation
- No prior chemotherapy
- See Disease Characteristics
- No prior pelvic or abdominal radiotherapy
- No prior radiotherapy for prior malignancy
- See Disease Characteristics
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma
Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.
Read the detailed description
OBJECTIVES:
- Compare survival and progression-free survival in patients with stage III endometrial carcinoma treated with tumor volume-directed pelvic radiotherapy with or without paraaortic radiotherapy followed by cisplatin and doxorubicin with or without paclitaxel.
II. Compare short and long-term toxic effects of these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy field (pelvic vs extended field). Within 8 weeks after surgery, patients receive tumor volume-directed pelvic radiotherapy with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16 weeks after surgery. Within 8 weeks of completing radiotherapy, patients are randomized to 1 of 2 chemotherapy treatment arms.
Arm I: Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or pegfilgrastim on days 2-11.
Arm II: Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 614 patients (307 per treatment arm) will be accrued for this study within 5.2 years.
- Conditions
- Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Endometrial Serous Adenocarcinoma, Stage III Uterine Corpus Cancer
- Being tested
- Doxorubicin Hydrochloride, Cisplatin, Filgrastim, Pegfilgrastim, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Given IV
CisplatinDrug
Given IV
FilgrastimBiological
Also called G-CSF, Nivestim, r-metHuG-CSF
Given SC
PegfilgrastimBiological
Also called Filgrastim SD-01, GCSF-SD01, Neulasta
Given SC
PaclitaxelDrug
Also called Anzatax, TAX
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (doxorubicin, cisplatin, filgrastim, pegfilgrastim) | Experimental | Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) SC or pegfilgrastim on days 2-11. Receives: Drug: Doxorubicin Hydrochloride; Drug: Cisplatin; Biological: Filgrastim; Biological: Pegfilgrastim |
| Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim) | Experimental | Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Doxorubicin Hydrochloride; Drug: Cisplatin; Biological: Filgrastim; Biological: Pegfilgrastim; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.
Recurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion.
Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization.
Intention to treat among eligible participants who receive random treatment allocation.
Measured: study entry up to 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 2000
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- Eastern Cooperative Oncology Group, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Howard Homesley, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006011
- Sponsor's protocol ID
- GOG-0184
- Other IDs
- NCI-2012-02350, ECOG-G0184, RTOG-EN0130, CDR0000068020, GOG-0184, GOG-0184, U10CA027469
- Status last verified
- Apr 2015
- First submitted
- 5 Jul 2000
- Last updated
- 19 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00006011
- Acronym / sponsor ID
- GOG-0184
- Conditions
- Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Endometrial Serous Adenocarcinoma, Stage III Uterine Corpus Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- Eastern Cooperative Oncology Group, National Cancer Institute (NCI)
- Study start
- Jul 2000
- Primary completion
- Mar 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 26 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.
Detailed description
OBJECTIVES:
- Compare survival and progression-free survival in patients with stage III endometrial carcinoma treated with tumor volume-directed pelvic radiotherapy with or without paraaortic radiotherapy followed by cisplatin and doxorubicin with or without paclitaxel.
II. Compare short and long-term toxic effects of these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy field (pelvic vs extended field). Within 8 weeks after surgery, patients receive tumor volume-directed pelvic radiotherapy with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16 weeks after surgery. Within 8 weeks of completing radiotherapy, patients are randomized to 1 of 2 chemotherapy treatment arms.
Arm I: Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or pegfilgrastim on days 2-11.
Arm II: Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 614 patients (307 per treatment arm) will be accrued for this study within 5.2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (doxorubicin, cisplatin, filgrastim, pegfilgrastim) | Experimental | Drug: Doxorubicin Hydrochloride, Drug: Cisplatin, Biological: Filgrastim, Biological: PegfilgrastimPatients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) SC or pegfilgrastim on days 2-11. |
| Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim) | Experimental | Drug: Doxorubicin Hydrochloride, Drug: Cisplatin, Biological: Filgrastim, Biological: Pegfilgrastim, Drug: PaclitaxelPatients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (33 listed)
- Histologically confirmed advanced endometrial carcinoma with any histology, including:
- Surgical stage III disease, including:
- Must have had prior surgery, including hysterectomy and bilateral salpingo-oophorectomy
- No recurrent disease
- No parenchymal liver metastases
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Doxorubicin HydrochlorideGiven IV | Drug | Arm I (doxorubicin, cisplatin, filgrastim, pegfilgrastim), Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim) |
| CisplatinGiven IV | Drug | Arm I (doxorubicin, cisplatin, filgrastim, pegfilgrastim), Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim) |
| FilgrastimAlso: G-CSF, Nivestim, r-metHuG-CSFGiven SC | Biological | Arm I (doxorubicin, cisplatin, filgrastim, pegfilgrastim), Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim) |
| PegfilgrastimAlso: Filgrastim SD-01, GCSF-SD01, NeulastaGiven SC | Biological | Arm I (doxorubicin, cisplatin, filgrastim, pegfilgrastim), Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim) |
| PaclitaxelAlso: Anzatax, TAXGiven IV | Drug | Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim) |
Primary outcome
Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.
Time frame: study entry up to 5 years post treatment
Recurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion. Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization. Intention to treat among eligible participants who receive random treatment allocation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Howard Homesley principal investigator
Gynecologic Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxorubicin Hydrochloride, Cisplatin and Filgrastim in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 1 site in United States.
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 33 inclusion and 0 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 19 May 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Eligible Patients Who Received a Random Treatment Allocation. (time frame: study entry up to 5 years post treatment). 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 19 May 2015.