Gynecologic Clinical Trials

Trial MenuList of Available Trials:

 

GOG 0238: “A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-only Recurrence of Carcinoma of the Uterine Corpus”

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo external-beam radiotherapy (EBRT) to the pelvis on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy* or low-dose rate interstitial brachytherapy*.
  • Arm II: Patients undergo EBRT as in Arm I and receive cisplatin IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Patients then undergo brachytherapy* as in Arm I.

NOTE: *IMRT will be allowed for the entire course of therapy, this is for the treatment of the whole pelvis and/or the boost in those cases not undergoing brachytherapy.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

-After completion of study treatment, patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

ELIGIBILITY:

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of endometrial cancer, including the following histological subtypes:

  • Adenocarcinoma

  • Adenocarcinoma with squamous differentiation

  • Mucinous adenocarcinoma

  • Squamous cell carcinoma

  • Mixed carcinoma

  • Undifferentiated carcinoma

  • Clear cell adenocarcinoma

  • Serous adenocarcinoma

  • Must have undergone prior complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy

  • Recurrent disease confined to the pelvis and/or vagina

  • No evidence of extrapelvic disease, including positive periaortic or inguino-femoral nodes by chest x-ray or CT scan

  • Prior primary surgical debulking (including removal of gross symptomatic disease in the pelvis and/or vagina) allowed provided there is residual disease that is evaluable clinically and/or by CT scan or MRI

  • Exenterative surgery is not permissible

  • Patients who have undergone prior complete surgical resection of the recurrent tumor and have no evidence of residual disease evaluable clinically and by CT scan or MRI after resection are not eligible

  • Patients enrolled subsequent to revision 11 with complete resection of gross recurrent disease are eligible

  • Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2

  • Life expectancy ≥ 3 months

  • Absolute neutrophil count ≥ 1,500/mm³

  • Platelet count ≥ 100,000/mm³

  • Creatinine normal OR creatinine clearance > 50 mL/min

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)

  • SGOT ≤ 2.5 times ULN

  • Alkaline phosphatase ≤ 2.5 times ULN

  • No sensory or motor neuropathy > grade 1

  • No septicemia or severe infection

  • No circumstances that would preclude study participation

  • No renal abnormalities (i.e., pelvic kidney, horseshoe kidney, or prior renal transplantation) that would require modification of radiation fields

  • No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

  • No significant history of cardiac disease, including uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within the past 6 months

  • No history of active collagen vascular disease

PRIOR CONCURRENT THERAPY:

  • At least 6 months since prior hormone therapy and/or systemic chemotherapy
  • No prior neoadjuvant chemotherapy for recurrent disease
  • No prior exenterative surgery
  • No prior vaginal, pelvic, or abdominal irradiation
  • No prior chemotherapy directed at the present recurrent disease
  • No prior cancer treatment that would preclude study treatment

OBJECTIVES:

Primary

  • Determine whether pelvic radiotherapy and cisplatin are more promising with respect to progression-free survival than pelvic radiotherapy alone in patients with recurrent endometrial cancer limited to the pelvis and vagina.

Secondary

  • Compare the sites of recurrence in patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.
  • Compare the prognostic significance of the location (central pelvis versus vagina) and size of the recurrence, in addition to the prognostic significance in the salvage setting, in terms of histological subtype, grade, age, race, performance status, and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy, in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

National Enrollment to Date: 18/210

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GOG 0263: “Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy”

OUTLINE: This is a multicenter study. Patients are stratified according to capillary-lymphovascular space involvement (positive vs. negative), stromal invasion (deep vs. middle vs. superficial), radiotherapy modality (external-beam radiation therapy [EBRT] vs. intensity-modulated radiation therapy [IMRT]), and cooperative group (KGOG vs. GOG). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo pelvic EBRT or IMRT 5 days a week for 5.5 weeks.
  • Arm II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in arm I. Treatment with cisplatin repeats every 7 days for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

-Patients complete questionnaires on smoking history, Functional Assessment of Cancer Therapy (FACT-G, Version 4), FACT-Neurotoxicity subscale, and the Brief Pain Inventory (BPI) at baseline and periodically during study.

-Tumor tissue and blood samples may be collected and banked for future biomarker and other analysis.

-After completion of study therapy, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.

 

ELIGIBILITY:

DISEASE CHARACTERISTICS:

  • Pathologically confirmed primary cervical cancer comprising one of the following cell types:
  • Squamous cell carcinoma
  • Adenosquamous carcinoma
  • Adenocarcinoma
  • Stage I-IIA disease
  • Initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
  • Patients with depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed must meet the following criteria:
  • Positive capillary-lymphovascular space involvement and one of the following:
  • Deep third penetration
  • Middle third penetration, clinical tumor ≥ 2 cm
  • Superficial third penetration, clinical tumor ≥ 5 cm
  • Negative capillary-lymphatic space involvement
  • Middle or deep third penetration, clinical tumor ≥ 4 cm
  • No patients with tumor in the parametria, pelvic lymph nodes, or any other extra-uterine site or with positive surgical margins

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphate ≤ 3 times ULN
  • SGOT ≤ 3 times ULN
  • No septicemia or severe infection
  • No intestinal obstruction or gastrointestinal bleeding
  • No post-operative fistula
  • No circumstances that do not permit completion of the study or the required study follow-up
  • No renal abnormalities requiring modification of radiation field (e.g., pelvic kidney or renal transplant)
  • No prior malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 3 weeks but ≤ 8 weeks since surgery
  • No prior radiotherapy or chemotherapy for cancer of the cervix
  • No prior cancer treatment that contraindicates this protocol therapy
  • No concurrent brachytherapy boost

OBJECTIVES:

Primary

  • To determine if post-operative adjuvant chemoradiotherapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in patients with intermediate-risk factors stage I-IIA cervical cancer after treatment with radical hysterectomy.

Secondary

  • To compare the overall survival (OS) of patients treated with these regimens.
  • To assess differences in incidence and severity of regimen-attributed adverse events in these patients.
  • To provide assessment of patient risk vs. benefit (positive study only).
  • To determine whether post-operative adjuvant CRT improves the health-related quality-of-life compared to RT alone.
  • To compare toxicity profiles with particular focus on treatment-related genitourinary, gastrointestinal, neurological, pain, and sexual adverse events in these patients.

Tertiary

  • To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients treated with these regimens.
  • To bank DNA from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients treated with these regimens.

National Enrollment to Date: 141/534

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GOG 0273: “Chemotherapy Toxicity On Quality of Life in Older Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer”

OUTLINE:
Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician.

-Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies.

-Patients' quality of life is assessed by the Functional Assessment of Cancer Therapy - Ovary (FACT-O), the Functional Assessment of Cancer Treatment - Neurotoxicity (FACT-Ntx subscale), the Instrumental Activities of Daily Living (IADL), and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed.

ELIGIBILITY:

DISEASE CHARACTERISTICS:

  • Patients must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the ovary, peritoneum, or fallopian tube either by surgery, biopsy, fine-needle aspiration (FNA), or paracentesis
  • A diagnosis of a mucinous cancer must be made by biopsy only
  • International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, or IV are eligible
  • Patients must have received no previous treatment for this malignancy other than surgery
  • Patient must be entered within eight weeks of confirmation of disease diagnosis by surgery, biopsy, FNA or paracentesis, or within twelve weeks of primary or staging surgery if patient received primary surgery
  • Patient and physician agree that they plan to conduct treatment according to Regimen 1 or Regimen 2
  • "Borderline tumors" (tumors of low malignant potential) by surgery or biopsy are excluded

PATIENT CHARACTERISTICS:

  • GOG performance status of 0, 1, 2 or 3

  • No GOG performance status of 4
  • ANC ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • Bilirubin normal
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Patients must be free of active infection requiring antibiotics
  • Patient can read and understand sufficient English to be able to respond to questions posed by the study instruments
  • No patients with other invasive malignancies whose previous cancer treatment contraindicates this protocol therapy
  • No patients with medical conditions that in the opinion of the investigator render treatment on this protocol unsafe
  • Patients must have signed an approved informed consent and HIPAA
  • In signing the consent, patients must agree to provide blood samples from which plasma will be extracted to be tested for research purposes

OBJECTIVES:

Primary

  • To determine whether the score on Instrumental Activities of Daily Living (IADL) obtained at time of registration is associated with the ability of patients to complete four courses of chemotherapy without dose reduction or a more than 7-day delay.
  • To estimate by regimen the percentage of patients who are able to complete four courses of chemotherapy regardless of dose reductions and delays.
  • To compare actual and calculated carboplatin area under the curve (AUC) in this patient population.

Secondary

  • To describe the percentage of patients who are entered after primary surgery versus those entered to receive primary or neoadjuvant chemotherapy, the percentage of patients who are treated with each allowed regimen, and the percentage of patients who eventually receive surgery in the primary chemotherapy group.
  • To determine whether the need for assistance with IADLs at time of registration is associated with choice of chemotherapy regimen (in both primary chemotherapy and primary surgery patients).
  • To explore whether age, baseline scores on the geriatric measures (functional status, nutritional status, or co-morbidity) and quality-of-life (QOL) are correlated with likelihood of completing four courses of chemotherapy without dose reduction or a more than 7-day delay.
  • To explore reasons for and timing of dose reductions and delays.
  • To describe toxicities, pre-/post-chemotherapy QOL, and

pre-/ post-chemotherapy scores on geriatric measures in this patient population.

Tertiary

  • To explore potential relationships of carboplatin AUC, paclitaxel clearance, and paclitaxel time above a plasma concentration of 0.05 mcM to nadir neutrophil and platelet counts during course 1 of treatment.
  • To explore the association between baseline IADL and survival.
  • To explore the association between IADL and the functional well-being (FWB) subscale in the Functional Assessment of Cancer Therapy - Ovary (FACT-O).

National Enrollment to date 238/290

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RTOG 0724: Phase III Randomized Study of Concurrent Chemotherapy and Pelvic RT With or Without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy

OUTLINE: This is a multicenter study. Patients are stratified according to planned use of brachytherapy (no vs. yes), radiotherapy modality (standard external beam radiotherapy [EBRT] vs. intensity-modulated radiotherapy [IMRT]), and radiotherapy dose (45 Gy vs. 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo standard EBRT or IMRT to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin IV over 1 hour once weekly for 6 weeks.

     NOTE: Some patients may also undergo brachytherapy beginning within 7 days after completion of radiotherapy.

  • Arm II: Patients receive chemoradiotherapy as in arm I. Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

-Quality of life is assessed by the FACT-GOG/NTX4, FACT-Cx, and FACIT-D questionnaires at baseline; at the completion of chemoradiotherapy; and then at 6, 12, and 24 months after completion of chemoradiotherapy.

-Blood and tissue samples may be collected for gene expression analysis by IHC and for biomarker and polymorphism studies.

-After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

ELIGIBILITY:

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery:
  • Positive pelvic nodes
  • Positive parametrium
  • Positive para-aortic nodes that have been completely resected and are PET/CT scan-negative
  • PET only required if positive para-aortic nodes during surgery
  • Clinical stage IA2, IB, or IIA disease (this corresponds to surgical TNM staging of T1-T2, N1, M0)
  • Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days
  • Para-aortic and pelvic node sampling required
  • If the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a PET-CT is recommended, but not required
  • A negative pre- or post-operative PET scan or PET-CT scan of the para-aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection
  • No gross residual disease
  • No neuroendocrine histology
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1

  • ANC ≥ 1,800/mm³
  • Platelets ≥ 100,000/mm³
  • WBC ≥ 4,000/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
  • Serum creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 1.5 times upper limit of normal
  • ALT and/or AST normal
  • Alkaline phosphatase normal
  • Known HIV positivity allowed provided CD4 count is ≥ 350/mm³ within the past 14 days
  • No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active co-morbidity, including any of the following:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • Transmural myocardial infarction within the past 6 months
  • Acute bacterial or fungal infection requiring IV antibiotics at the time of study entry
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
  • Coagulation defects
  • No prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior systemic chemotherapy for the current cervical cancer
  • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields

OBJECTIVES:

Primary

  • To determine if administering adjuvant systemic chemotherapy after chemoradiotherapy will improve disease-free survival compared to chemoradiotherapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after radical hysterectomy.

Secondary

  • To evaluate adverse events.

  • To evaluate overall survival.
  • To evaluate quality of life.
  • To evaluate chemotherapy-induced neuropathy.
  • To perform a post-hoc dose-volume evaluation between patients treated with standard radiotherapy and patients treated with intensity-modulated radiotherapy with respect to toxicity and local control.
  • To collect fixed tissue samples to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival.
  • To collect blood samples to identify secreted factors from serum and plasma that may be associated with adverse events or outcome and to identify SNPs in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy.

National Enrollment to Date: 74/400

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