OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206

NCT00112086 | Completed Phase 2 DMC

• 2 other identifiers: JCOG0206C000000005
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

A feasibility study of neoadjuvant chemotherapy (NAC) followed by interval cytoreductive surgery (ICS) and postoperative chemotherapy for stage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas.

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms

Keywords

ovarian neoplasms; laparoscopy; neoadjuvant therapy; interval cytoreductive surgery

Outcome Measures

Primary Outcomes (1)

• proportion of clinical complete remission

Secondary Outcomes (10)

• positive predictive value (PPV) of prelaparoscopic diagnosis concerning the origin and histology

• proportion of the patients diagnosed as müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings

• PPV of prelaparoscopic diagnosis concerning clinical stage; proportion of the patients diagnosed as stage III or IV by laparoscopic inspection among those diagnosed by prelaparoscopic findings

• PPV of overall prelaparoscopic diagnosis; proportion of the patients diagnosed as stage III or IV müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings

• response rate to NAC among patients whose clinical diagnosis is confirmed by laparoscopy

Interventions

Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) DRUG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Japan Clinical Oncology Group: lead
• Ministry of Health, Labour and Welfare, Japan: collaborator

Study Sites (1)

National Cancer Center

Tsukiji, 5-1-1, Chuo-ku, Tokyo, 1040045, Japan

Location

Related Publications (2)

• Onda T, Kamura T, Ishizuka N, Katsumata N, Fukuda H, Yoshikawa H; Japan Clinical Oncology Group Study JCOG0206. Feasibility study of neoadjuvant chemotherapy followed by interval cytoreductive surgery for stage III/IV ovarian, tubal and peritoneal cancers: Japan Clinical Oncology Group Study JCOG0206. Jpn J Clin Oncol. 2004 Jan;34(1):43-5. doi: 10.1093/jjco/hyh007.

  PMID: 15020662 BACKGROUND

• Onda T, Kobayashi H, Nakanishi T, Hatae M, Iwasaka T, Konishi I, Shibata T, Fukuda H, Kamura T, Yoshikawa H. Feasibility study of neoadjuvant chemotherapy followed by interval debulking surgery for stage III/IV ovarian, tubal, and peritoneal cancers: Japan Clinical Oncology Group Study JCOG0206. Gynecol Oncol. 2009 Apr;113(1):57-62. doi: 10.1016/j.ygyno.2008.12.027. Epub 2009 Jan 31.

  PMID: 19181369 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms

Interventions

Neoadjuvant Therapy; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Hiroyuki Yoshikawa, MD

  University of Tsukuba

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2005
• First Posted: May 30, 2005
• Study Start: January 1, 2003
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

JP (1)