A Phase 3 interventional study of Doxorubicin Hydrochloride and Cisplatin in Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma and Endometrial Clear Cell Adenocarcinoma, sponsored by Gynecologic Oncology Group. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2015-05-19.
Sponsored by Gynecologic Oncology Group · Phase 3, Interventional, and Treatment
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.
OBJECTIVES:
I. 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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 659 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.
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Inclusion Criteria:
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
Paraaortic lymph node sampling allowed
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.
Drug: Doxorubicin Hydrochloride · Drug: Cisplatin · Biological: Filgrastim · Biological: Pegfilgrastim
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.
Drug: Doxorubicin Hydrochloride · Drug: Cisplatin · Biological: Filgrastim · Biological: Pegfilgrastim · Drug: Paclitaxel
Given IV
Given IV
Given SC
Also known as: G-CSF, Nivestim, r-metHuG-CSF
Given SC
Also known as: Filgrastim SD-01, GCSF-SD01, Neulasta
Given IV
Also known as: Anzatax, TAX
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.
Time frame: study entry up to 5 years post treatment
All patients were initially registered and initiated radiation treatment. Following succsessful completion of radiation treatment, participants with no evidence of disease received a random treatment allocation.
| Milestone | Arm 1 | Arm 2 | Radiation (RT) Only |
|---|---|---|---|
| Started | 288 | 298 | 73 |
| Completed | 223 | 221 | 0 |
| Not completed | 65 | 77 | 73 |
| Withdrew: Disease progression | 13 | 6 | 26 |
| Withdrew: Refused further treatment | 15 | 13 | 26 |
| Withdrew: Adverse event | 15 | 39 | 5 |
| Withdrew: Death | 0 | 1 | 2 |
| Withdrew: Other | 4 | 2 | 5 |
| Withdrew: Ineligible | 18 | 16 | 9 |
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.
| participants | Arm 1 | Arm 2 |
|---|---|---|
| Alive, Recurrence-Free | 159 | 175 |
| Recurrence or Death | 111 | 107 |
Collected over The frequencies of any serious adverse event or other adverse events by category or specific term occurring during chemotherapy treatment and up to 30 days after stopping the study treatment are reported.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | — | 10/261 (3.8%) | 259/261 (99.2%) |
| Arm 2 | — | 21/278 (7.6%) | 278/278 (100%) |
| Event | Arm 1 | Arm 2 |
|---|---|---|
| Thrombosis/EmbolismVascular disorders | 0/261 | 4/278 |
| Neutrophils/GranulocytesBlood and lymphatic system disorders | 0/261 | 3/278 |
| Supraventricular ArrhythmiasCardiac disorders | 0/261 | 2/278 |
| Diarrhea (without Colostomy)Gastrointestinal disorders | 0/261 | 2/278 |
| Cns Cerebrovascular IschemiaNervous system disorders | 1/261 | 1/278 |
| Abdominal Pain or CrampingGeneral disorders | 1/261 | 1/278 |
| Wound-InfectiousSkin and subcutaneous tissue disorders | 1/261 | 0/278 |
| IleusGastrointestinal disorders | 1/261 | 0/278 |
| AnorexiaGastrointestinal disorders | 1/261 | 0/278 |
| NauseaGastrointestinal disorders | 1/261 | 1/278 |
| Event | Arm 1 | Arm 2 |
|---|---|---|
| LeukopeniaBlood and lymphatic system disorders | 190/261 | 250/278 |
| NeutropeniaBlood and lymphatic system disorders | 158/261 | 236/278 |
| AnemiaBlood and lymphatic system disorders | 137/261 | 205/278 |
| AlopeciaSkin and subcutaneous tissue disorders | 185/261 | 179/278 |
| ConstitutionalGeneral disorders | 105/261 | 133/278 |
| ThrombocytopeniaBlood and lymphatic system disorders | 55/261 | 116/278 |
| Other PainGeneral disorders | 63/261 | 101/278 |
| NauseaGastrointestinal disorders | 89/261 | 95/278 |
| Other GastrointestinalGastrointestinal disorders | 73/261 | 88/278 |
| VomitingGastrointestinal disorders | 75/261 | 79/278 |
Total number of eligible participants.
| Age, Continuous(years) | Arm 1 | Arm 2 | Radiation (RT) Only | Total |
|---|---|---|---|---|
| Mean | 58.8 ± 11.1 | 58.8 ± 9.5 | 63.9 ± 10.7 | 59.3 ± 10.5 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Radiation (RT) Only | Total |
|---|---|---|---|---|
| Female | 270 | 282 | 64 | 616 |
| Male | 0 | 0 | 0 | 0 |
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