Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Ovarian Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Fallopian Tube Diseases

Ovarian Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)

Hiroyuki Yoshikawa, MD

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.

The purposes are to assess the safety and efficacy of the treatment starting with NAC and to know whether we can accurately diagnose these advanced carcinomas by imaging studies, cytologic findings and tumor markers without staging laparotomy or laparoscopy. Fifty-six patients with advanced mullerian carcinomas will be recruited to the study. After confirmation of diagnosis by laparoscopic inspection and biopsies, patients undergo 4 cycles of chemotherapy as NAC followed by ICS and additional 4 cycles of postsurgical chemotherapy. The primary endpoint is proportion of clinical complete remission after accomplishment of the protocol treatment and the major secondary endpoint is positive predictive value of diagnosis before laparoscopy regarding tumor origin, histology and stage. Based on the result of this study, we will conduct a phase III study to compare the treatment starting with NAC and primary cytoreductive surgery followed by postsurgical chemotherapy.

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

Feasibility Study of Neoadjuvant Chemotherapy Followed by Interval Cytoreductive Surgery for Stage III/IV Ovarian, Tubal and Peritoneal Cancers: JCOG0206

Ministry of Health, Labour and Welfare, Japan

Japan Clinical Oncology Group

Hiroyuki Yoshikawa , MD, Study Chair

Carcinoma, Ovarian Epithelial

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Epithelial Cancer

women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) cytoreductive surgery

women with stage III-IV ovarian cancer, undergoing delayed (\>5 cycles of chemotherapy) cytoreductive surgery

women with stage III-IV ovarian cancer, undergoing \>5 cycles of chemotherapy alone (no cytoreductive surgery)

cytoreductive surgery after 3-4 cycles of chemotherapy

interval cytoreductive surgery

delayed cytoreductive surgery

no cytoreductive surgery (\>5 cycles of chemotherapy alone)

no surgery

Faiza Gaba

To compare patient outcomes following interval and delayed cytoreductive surgeries and no surgery (neoadjuvant chemotherapy alone) and international variations in access to cytoreductive surgeries in women with advanced stage ovarian cancer.

Standard of care in patients with advanced ovarian cancer is primary cytoreductive surgery followed by chemotherapy. Neoadjuvant chemotherapy and interval cytoreductive surgery is an alternative in selected patients. Most data exist with interval cytoreductive surgery following 3-4 cycles of chemotherapy, however, some patients experience a delay. So far, the impact of delayed cytoreductive surgery (following \>5 cycles of chemotherapy) on patient outcomes is poorly defined. There is also a paucity of data in women who undergo no surgery (\>5 cycles of chemotherapy alone) and factors influencing international discrepancies in access to cytoreductive surgery.

Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer

Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer: A GO SOAR Led Study (GO SOAR2)

defined from date of diagnosis to date of death by any cause or loss to follow-up

defined from date of diagnosis to date of first recurrence

topic guide interview questionnaire to be used to elicit factors aiding/preventing access to cytoreductive surgery internationally

R0 = no visible disease, R1 = \<10mm visible residual disease, R2 = \>10mm visible residual disease

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206	NCT00112086	Ovarian Neoplas... Fallopian Tube ... Peritoneal Neop...	Neoadjuvant che...	20 Years - 75 Years	Japan Clinical Oncology Group
Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer	NCT05523804	Ovarian Cancer	interval cytore... delayed cytored... no surgery	18 Years -	NHS Grampian
Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer	NCT05523804	Ovarian Cancer	interval cytore... delayed cytored... no surgery	18 Years -	NHS Grampian
Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer	NCT05523804	Ovarian Cancer	interval cytore... delayed cytored... no surgery	18 Years -	NHS Grampian
Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer	NCT05523804	Ovarian Cancer	interval cytore... delayed cytored... no surgery	18 Years -	NHS Grampian
OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206	NCT00112086	Ovarian Neoplas... Fallopian Tube ... Peritoneal Neop...	Neoadjuvant che...	20 Years - 75 Years	Japan Clinical Oncology Group

Spots Global Cancer Trial Database for interval cytoreductive surgery