Please select the eligibility criteria that correspond to the clinical trial below.
Title: Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
Brief Summary: Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs. neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point is the evaluation and comparison of the surgical complications of primary surgery and IDS and the evaluation of the progression free survival (PFS)


Options:
A: Inclusion Criteria:

* Stage III or IV müllerian carcinoma by prelaparoscopic clinical findings including imaging studies (CT, MRI or ultrasonography)
* Cytology of ascites, pleural effusions, or fluids obtained by tumor centesis
* Malignancies of other origins, such as breasts and digestive tract, should be excluded by endoscopy, opaque enema, or ultrasonography when these malignancies are suspected from symptoms, physical examinations or imaging diagnosis.
* CA125\>200U/ml and CEA\<20ng/ml.
* Clinically deemed to be a candidate for debulking surgery without evidence of brain, bone, bone marrow metastases, multiple lung, or multiple liver metastases
* Presence of at least one measurable lesion
* Previously untreated for these malignancies and no history of treatment with chemotherapy or radiotherapy even for other diseases
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3,
* Adequate bone marrow, hepatic, renal, cardiac and respiratory functions, and
* Written informed consent.

Exclusion Criteria:

* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
* Pregnant or nursing
* Severe mental disorders
* Systemic and continuous use of steroidal drugs
* Active infections
* Uncontrolled hypertension
* Diabetes mellitus, uncontrolled or controlled with insulin
* History of cardiac failure, unstable angina, myocardial infarction within 6 months prior to the registration
* Liver cirrhosis or bleeding tendency contraindicating debulking surgery
* Intestinal occlusion necessary for surgical treatment
* Hypersensitivity to alcohol
B: Inclusion Criteria:

* suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer FIGO stage IIIB-IV (IV only if resectable metastasis)
* Females aged ≥ 18 years
* Patients who have given their written informed consent
* Good performance status (ECOG 0/1)
* Good ASA score (1/2)
* Preoperative CA 125/CEA ratio ≥ 25 (if CA-125 is elevated)\*
* If \<25 and/or biopsy with non-serous, non-endometroid histology, esophago-gastro-duodenoscopy (EGD) and colonoscopy mandatory to exclude gastrointestinal primary cancer
* Assessment of an experienced surgeon, that based on all available information, the patient can undergo the procedure and the tumor can potentially be completely resected
* Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. This ANC cannot have been induced or supported by granulocyte colony stimulating factors.
* Platelet count ≥ 100 x 109/L.
* Renal function: Serum-Creatinine ≤ 1.5 x institutional upper limit normal (ULN).
* Hepatic function:

  * Bilirubin ≤ 1.5 x ULN.
  * SGOT ≤ 3 x ULN
  * Alkaline phosphatase ≤ 2.5 x ULN.
* Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1.

Exclusion Criteria:

* Non epithelial ovarian malignancies and borderline tumors
* Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.
* Recurrent ovarian cancer
* Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy
* Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in the mediastinum in CT chest and abdomen/pelvis
* Clinical relevant dysfunctions of blood clotting (including drug induced)
* Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)
* Pregnancy
* Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
* Any reasons interfering with regular follow-up
C: Inclusion Criteria:

* Patients with suspected advanced ovarian cancer (FIGO stage IIIC)
* PIV ≥ 8, PIV ≤ 12
* Estimated life expectancy of at least 4 weeks.
* PS ≤ 2
* Appropriate respiratory, hepatic, cardiological, bone marrow and renal functions (Creatinine Clearance \> 60 mL/min according to Cockcroft formula)
* Patient capable of consent.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Non-appropriate respiratory, hepatic, cardiological, bone marrow and renal functions
* Large size mass reaching the xiphoid, occupying all the abdominal cavity and/or infiltrating the abdominal wall.
* Mesenteric retraction
D: DISEASE CHARACTERISTICS:

* Histologically proven stage IIIC or IV ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma

  * If biopsy is not available, evidence of adenocarcinoma by fine needle aspiration allowed if all of the following are true:

    * Presence of pelvic ovarian mass
    * Omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymph node metastasis
    * CA 125/carcinoembryonic antigen ratio greater than 25 (if ratio less than 25, barium enema or colonoscopy AND gastroscopy or radiological examination of the stomach must be negative for primary tumor)
    * Normal mammography (if CA 125/carcinoembryonic antigen ratio less than 25)
* Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan
* No brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 1.25 times upper limit of normal (ULN)

Renal:

* Creatinine less than 1.25 times ULN

Other:

* No other serious disabling diseases contraindicating primary cytoreductive surgery or primary platin-based chemotherapy
* No other prior primary malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin
* No psychological, familial, sociological, or geographical condition potentially preventing protocol compliance or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* No other prior procedures except diagnostic biopsy by laparotomy or laparoscopy

Answer: C