Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Uterine Cervical Neoplasms

Carcinoma, Adenosquamous

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.

Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks and concurrent weekly cisplatin 40 mg/m\^2 for five weeks.

cisplatin

intensity-modulated radiation therapy

Anuja Jhingran, MD

RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.

OBJECTIVES:

* Determine the transportability of intensity modulated radiotherapy (IMRT) to a multi-institutional setting in patients with resected endometrial or cervical cancer.
* Compare the efficacy, in terms of reducing short-term bowel injury, of IMRT versus standard treatments.
* Assess adverse events related to this regimen.
* Estimate the rates of local-regional control, distant metastasis, and disease-free and overall survival.
* Evaluate chemotherapy compliance with this regimen for patients with cervical carcinoma.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer).

All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years.

PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.

Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery

A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma

Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is \<= 80%. The alternative hypothesis is that the true probability is \>= 95%.

For \[vagina / pelvic lymph nodes\]: UD is defined as: The 90% isodose surface covers \< 95% of \[internal target volume (ITV)/ planned target volume (PTV)\] 50.4 or \> 5% of the \[ITV/PTV\] 50.4 receives over 115%.

Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.

Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.

Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method.

Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method. Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary.

Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.

Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

National Cancer Institute (NCI)

NRG Oncology

Radiation Therapy Oncology Group

Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.

Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)

Endometrial Cancer: IMRT

Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)

Cervical Cancer: IMRT + Chemotherapy (Cisplatin)

Total

Age, Continuous

Sex: Female, Male

Wendy Seiferheld

Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)

A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.

A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.

Eligible patients who started study treatment

Percentage of Patients With Grade 2+ Bowel Adverse Events

Non-hematologic

Overall

Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events

Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events

Eligible patients in the chemotherapy group (cervical cancer patients) who started study treatment

Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant

Rate of Local-regional Failure at Five Years

Rate of Distant Metastases at Five Years

Rate of Disease-free Survival at Five Years

Rate of Overall Survival at Five Years

Overall Study

Rare Diseases

Cystadenocarcinoma, Serous

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Epithelial-myoepithelial Carcinoma

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

paclitaxel

adjuvant therapy

radiation therapy

Kathryn M. Greven, MD

Richard R. Barakat, MD

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without combination chemotherapy for endometrial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without combination chemotherapy following surgery in treating patients who have stage I or stage II endometrial cancer.

OBJECTIVES:

* Compare the relapse-free survival in patients with stage I or II endometrial cancer treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total abdominal hysterectomy and bilateral salpingo-oophorectomy.
* Compare the patterns of recurrence and the acute and late toxicity profiles associated with these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (IC-IIA vs IIB). Patients are randomized to one of two treatment arms.

* Arm I: Within 8 weeks after surgery, patients receive radiotherapy once daily 5 days a week for 5.5 weeks.
* Arm II: Within 8 weeks after surgery, patients receive radiotherapy as in arm I concurrently with cisplatin IV over 2-4 hours on days 1 and 28. After completion of radiotherapy, patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 2-4 hours on days 56, 84, 112, and 140.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 436 patients (218 per treatment arm) will be accrued for this study.

Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer

A Phase III Study of Adjuvant Postoperative Irradiation With or Without Cisplatin/Taxol Chemotherapy Following TAH/BSO for Patients With Endometrial Cancer

Gynecologic Oncology Group

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

doxorubicin hydrochloride

low-LET photon therapy

Marcus E. Randall, MD

RATIONALE: 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. It is not yet known which treatment regimen is more effective for endometrial cancer.

PURPOSE: Randomized phase III trial to compare radiation therapy with chemotherapy in treating patients who have advanced endometrial cancer.

OBJECTIVES: I. Compare overall survival, progression-free interval, and patterns of failure of maximally debulked patients with stage III/IV endometrial carcinoma treated with whole-abdominal irradiation vs. doxorubicin/cisplatin. II. Compare the incidence and type of acute and late adverse events observed with these two treatment regimens. III. Compare changes in fatigue, elimination, and neurologic impairment that impact on quality of life in patients treated with these two regimens. IV. Assess the difference in short-term versus long-term impact on quality of life between the two treatment groups. V. Compare quality-of-life outcomes over time between these two treatment groups.

OUTLINE: Randomized study. Arm I: Radiotherapy. Whole-abdominal irradiation using equipment with photon energies ranging from 6 to 25 MV. Arm II: 2-Drug Combination Chemotherapy. Doxorubicin, DOX, NSC-123127; Cisplatin, CDDP, NSC-119875.

PROJECTED ACCRUAL: It is anticipated that 355 patients will be entered over 7.4 years.

Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer

WHOLE ABDOMINAL RADIOTHERAPY VERSUS CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY IN ADVANCED ENDOMETRIAL CARCINOMA -- PHASE III

Symptoms and General Pathology

Recurrence

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Cystic, Mucinous, and Serous

Adenocarcinoma of the Appendix

Thalidomide

Immunosuppressive Agents

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

thalidomide

laboratory biomarker analysis

D. Scott McMeekin

Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent endometrial cancer. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor

OBJECTIVES:

I. Determine the antitumor cytostatic activity of thalidomide, in terms of 6-month progression-free survival, in patients with recurrent or persistent endometrial carcinoma.

II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the partial and complete response rates in patients treated with this drug.

IV. Determine the duration of progression-free and overall survival in patients treated with this drug.

V. Determine the effect of this drug on initial performance status and histological grade in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery	NCT00331760	Cervical Cancer Endometrial Can...	cisplatin intensity-modul...	18 Years -	Radiation Therapy Oncology Group
Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer	NCT00006027	Endometrial Can...	cisplatin paclitaxel adjuvant therap... radiation thera...	18 Years - 120 Years	Radiation Therapy Oncology Group
Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer	NCT00002493	Endometrial Can... Psychosocial Ef...	cisplatin doxorubicin hyd... low-LET photon ...	-	GOG Foundation
Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer	NCT00025467	Endometrial Ade... Endometrial Ade... Endometrial Ade... Endometrial Cle... Endometrial Pap... Recurrent Endom...	thalidomide laboratory biom...	-	National Cancer Institute (NCI)
Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer	NCT00025467	Endometrial Ade... Endometrial Ade... Endometrial Ade... Endometrial Cle... Endometrial Pap... Recurrent Endom...	thalidomide laboratory biom...	-	National Cancer Institute (NCI)
Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer	NCT00002493	Endometrial Can... Psychosocial Ef...	cisplatin doxorubicin hyd... low-LET photon ...	-	GOG Foundation

Spots Global Cancer Trial Database for endometrial adenoacanthoma