S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer

Browse trials for

• Ovarian Neoplasms 2,695
• Carcinoma, Ovarian Epithelial 1,617
• Fallopian Tube Neoplasms 720

Keywords

• stage III ovarian epithelial cancer
• stage IV ovarian epithelial cancer
• ovarian undifferentiated adenocarcinoma
• ovarian serous cystadenocarcinoma
• ovarian mucinous cystadenocarcinoma
• ovarian endometrioid adenocarcinoma
• ovarian clear cell cystadenocarcinoma
• fallopian tube cancer
• peritoneal cavity cancer

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 62 is close to the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Eligibility criteria

Study arms

• Experimental
  chemo/debulking surgery/IP chemo

  neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)

  Drug: carboplatin · Drug: paclitaxel · Procedure: debulking surgery

Interventions

• Drugcarboplatin

  pre-surgery - target AUC=6, Day 1 IV, q 21 days X 3 cycles post-surgery - target AUC=5, Day 1 IP, q 28 days X 6 cycles

  Also known as: carbo

• Drugpaclitaxel

  pre-surgery - 175 mg/m2 IV Day 1, q 21 days X 3 cycles post-surgery - 175 mg/m2 IV Day 1, q 28 days X 6 cycles AND 60 mg/m2 IP Day 8, q 28 days X 6 cycles

  Also known as: Taxol

• Proceduredebulking surgery

  exploratory laparotomy, interval cytoreduction (to \< 1 cm residual)

  Also known as: surgery, debulking, cytoreduction, laparotomy

Primary outcomes

1. Overall Survival

   Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.

   Time frame: assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5

2. Progression-Free Survival

   Progression was defined as a CA-125 value that is both twice the nadir since registration and greater than 70 units/ml, and is confirmed by a second determination at least 7 days apart, or appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring removal from protocol treatment. Progression-Free Survival was defined as the time from the date of registration to the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.

   Time frame: Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.

Baseline characteristics

Publications

• Tiersten AD, Liu PY, Smith HO, Wilczynski SP, Robinson WR 3rd, Markman M, Alberts DS. Phase II evaluation of neoadjuvant chemotherapy and debulking followed by intraperitoneal chemotherapy in women with stage III and IV epithelial ovarian, fallopian tube or primary peritoneal cancer: Southwest Oncology Group Study S0009. Gynecol Oncol. 2009 Mar;112(3):444-9. doi: 10.1016/j.ygyno.2008.10.028. Epub 2009 Jan 12. PubMed 19138791 ↗