Clinical trial · Interventional

Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

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

NCT00006011CI-TRIAL-00017943completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Endometrial Adenocarcinoma	Endometrial Adenocarcinoma	CURATED_BROADER	0.80
Endometrial Adenosquamous Carcinoma	Endometrial Adenosquamous Carcinoma	ONTOLOGY_EXACT	0.98
Endometrial Clear Cell Adenocarcinoma	Endometrial Clear Cell Adenocarcinoma	ONTOLOGY_EXACT	0.98
Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation	Endometrial Endometrioid Adenocarcinoma, Variant with Squamous Differentiation	ONTOLOGY_EXACT	0.98
Endometrial Serous Adenocarcinoma	Endometrial Serous Adenocarcinoma	ONTOLOGY_EXACT	0.98
Stage III Uterine Corpus Cancer	Malignant Uterine Corpus Neoplasm	CURATED_BROADER

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Cisplatin	Drug	Cisplatin	ALIAS
Doxorubicin Hydrochloride	Drug	Doxorubicin	ALIAS
Filgrastim	Biological	Filgrastim	ALIAS
Paclitaxel	Drug	Paclitaxel	ALIAS
Pegfilgrastim	Biological	Pegfilgrastim	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I (doxorubicin, cisplatin, filgrastim, pegfilgrastim)
description
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.
interventionNames
1. Drug: Doxorubicin Hydrochloride
2. Drug: Cisplatin
3. Biological: Filgrastim
4. Biological: Pegfilgrastim
type
EXPERIMENTAL
label
Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim)
description
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.
interventionNames
1. Drug: Doxorubicin Hydrochloride
2. Drug: Cisplatin
3. Biological: Filgrastim

Eligibility

Eligibility (as posted)

Sex: Female

Show eligibility criteria text

Inclusion Criteria:

* 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
  * 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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jul 1, 2000
Primary completion: Mar 1, 2010
Completion: —
First posted: Jan 27, 2003
Last update posted: May 19, 2015
Results first posted: Jun 26, 2014
Enrollment: 659 (actual)
Lead sponsor: Gynecologic Oncology Group NETWORK
Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute (NCI)

Data updated 22 days agoSource updated May 19, 2015source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.