Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian, peritoneal, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or fallopian tube cancer.


Options:
A: 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
B: 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
C: Inclusion Criteria:

* Primary diagnosis of invasive epithelial ovarian cancer FIGO stage IIB-IV (IV only if resectable metastasis in pleura, liver, spleen, and/or abdominal wall)
* Macroscopic complete resection
* Age: 18 - 75 years
* Patients who have given their signed and written informed consent
* Good performance status (ECOG 0/1)

Exclusion Criteria:

* Non epithelial ovarian malignancies and borderline tumors
* Intraoperative clinically suspicious lymph nodes (bulky nodes)
* 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
* Diseases of the lymph system (including lymph edema of unknown origin)
* Clinical relevant dysfunctions of blood clotting (including medicamentous conditioned reasons, e.g. ASS, if not stopped at least 7 days prior to surgery)
* Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)
* Prior retroperitoneal lymph node dissection (systematic or sampling)
* Pregnancy
* Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
* Any reasons interfering with regular follow-up
D: 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

Answer: B