Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Optional Postoperative Normothermic Intraperitoneal (IP) Chemotherapy to Treat Primary or Recurrent Carcinoma of Ovarian, Fallopian Tube, Uterine, or Peritoneal Origin
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Incidence of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) guidelines
研究概览
简要总结
This phase I trial studies the side effects and how well surgery and heated chemotherapy with or without non-heated chemotherapy after surgery works in treating patients with ovarian, fallopian tube, uterine, or peritoneal cancer. Giving a dose of heated chemotherapy into the abdomen during surgery that is done to remove ovarian, fallopian tube, uterine, or peritoneal cancer may help lower the risk of the cancer coming back. Giving unheated chemotherapy drugs directly into the abdomen after surgery may kill more tumor cells.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative normothermic intraperitoneal (IP) chemotherapy is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up.
SECONDARY OBJECTIVES:
I. To determine quality of life (QoL) and compare the outcomes to a historical control of IP chemotherapy (no HIPEC) for women with ovarian cancer.
II. To determine whether cytoreductive surgery with HIPEC alone is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provided informed consent
- •Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV, or recurrent ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, confined to abdominal cavity, including those who have completed neoadjuvant chemotherapy and primary surgery
- •Gynecologic Oncology Group (GOG) or Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky scale (KPS) >= 70%
- •Patients who are platinum-sensitive or platinum resistant
- •Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician
- •For patients with newly diagnosed-ovarian/tubal/peritoneal cancer who have received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following:
- •Decline in serum cancer antigen (CA) 125 level
- •At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging
- •Improvement of ascites volume
- •Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery
- •Resolution of any effects of prior therapy (except alopecia and peripheral neuropathy) to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) grade =< 1 and to baseline laboratory values as defined
- •Hemoglobin (HGB) >= 9 g/dL
- •White blood cell (WBC) >= 3,000/mcL
- •Absolute neutrophil count (ANC) >= 1,500/mcL
- •Platelets (PLT) >= 100,000/mcL
- •Total bilirubin within normal institutional limits
- •Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN)
- •Creatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to Cockcroft-Gault formula
- •Neuropathy (sensory and motor) NCI CTCAE grade =< 2
- •Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control
- •Serum albumin >= 2.5
- •No active infection requiring antibiotics
- •Preoperative or intraoperative (frozen section) diagnosis of ovarian, peritoneal, fallopian tubal or uterine cancer
- •Surgery achieves either no gross residual disease (R0) or optimal cytoreductive status defined as no single lesion measuring more than 5.0 mm in its greatest diameter
- •Stable from a cardiopulmonary standpoint to continue with prolonged surgery and anesthesia
排除标准
- •Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included
- •Patients whose disease has progressed following at least 3 cycles of neoadjuvant chemotherapy as defined by at least one of the following:
- •Doubling of serum CA-125 level
- •At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions
- •Clinical deterioration (worsening ascites, carcinomatous ileus, malignant bowel obstruction, severe hypoalbuminemia, declining performance status)
- •Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
- •Patients whose circumstances do not permit completion of the study or the required follow-up
- •Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral salpingo-oophorectomy
- •Other active invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 1 year after completion of treatment)
- •Metastatic non-gynecologic or breast primaries
- •Sub-optimal resection as their surgical outcome
- •Intraoperative frozen section suggesting hepatobiliary, pancreatic, adrenal, or urinary tract cancer
研究组 & 干预措施
Treatment (surgery, HIPEC cisplatin)
Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes.
Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.
干预措施: Carboplatin (Drug)
Treatment (surgery, HIPEC cisplatin)
Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes.
Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.
干预措施: Cisplatin (Drug)
Treatment (surgery, HIPEC cisplatin)
Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes.
Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.
干预措施: Gemcitabine Hydrochloride (Drug)
Treatment (surgery, HIPEC cisplatin)
Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes.
Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (surgery, HIPEC cisplatin)
Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes.
Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.
干预措施: Paclitaxel (Drug)
Treatment (surgery, HIPEC cisplatin)
Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes.
Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.
干预措施: Pegylated Liposomal Doxorubicin Hydrochloride (Drug)
Treatment (surgery, HIPEC cisplatin)
Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes.
Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.
干预措施: Quality-of-Life Assessment (Other)
Treatment (surgery, HIPEC cisplatin)
Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes.
Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Incidence of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) guidelines
时间窗: Up to 3 months post-surgery
Toxicity for both primary and recurrent groups will be summarized using frequency tables.
次要结局
- Quality of life (QoL) assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QoL questionnaire(Up to 15 months post-surgery)
- Progression-free survival (PFS)(From time-of-study entry to time-of-detection of new lesions on computed tomography imaging that is triggered by CA125 progression as defined by Gynecologic Cancer Intergroup Criteria (GCIG) or clinical symptoms or deterioration, assessed up to 3 years)