Information sheet on the clinical study - SMARAGD

Main indication

Patients with advanced or metastatic epithelial ovarian, fallopian tube, or primary peritoneal carcinoma ((m)OC Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage IIb–IV) or locally advanced and inoperable or metastatic endometrioid carcinoma ((m)EC FIGO Stage III–IV)
 

Study Name (Study Type)

SMARAGD  

Study sponsor

IOMEDICO

FOR RUSH READERS:

Study for patients with advanced or metastatic epithelial ovarian, fallopian tube, or primary peritoneal cancer

Which conditions are being treated in this study?

Ovarian, fallopian tube, or primary peritoneal cancer

Are specific subgroups of patients with any of the aforementioned conditions being treated?

Patients with locally advanced and inoperable or metastatic endometrioid carcinoma

Background on the study medication

None

Study procedure

Participation in the patient survey (PRO module) is optional.

  Quality of life is assessed using specific, validated questionnaires. In addition to questions regarding health-related quality of life, specific questionnaires for ovarian cancer (Functional Assessment of Cancer Therapy – Ovarian (FACT-O)) and for endometrial cancer (Functional Assessment of Cancer Therapy – Endometrial (FACT-En)) are used.

Patients are asked to complete the questionnaire before the start of treatment and then every two months, and every three months starting from the 6th month. For (m)OC and (m)EC, the duration of the patient survey is a maximum of 36 months (3 years). The first questionnaire will be distributed by the treating center; subsequent questionnaires will be mailed to patients’ homes by iOMEDICO SMO.

Inclusion Criteria

• Patients with high-grade serous carcinoma of the ovaries, fallopian tubes, and primary peritoneum
• Patients with newly diagnosed FIGO Stage IIb–IV for whom systemic treatment (adjuvant/curative or palliative) is
  planned or
• Patients with first progression/recurrence who have already received systemic therapy and are about to begin their first systemic recurrence therapy.
  OR
• locally advanced, inoperable, or metastatic endometrial cancer (FIGO Stage III–IV) at the start of first-line systemic palliative
  
  
  therapy Written patient consent:
• Patients participating in the patient-reported outcomes survey (PRO module): Consent dated and signed before the
  start or on the day of systemic therapy
• Patients not participating in the patient survey (PRO module): Consent dated and signed within six weeks of the start of systemic therapy
• Patients who are 18 years of
  age or older  

Exclusion criteria

Patients with:

• Initial diagnosis of early OC (FIGO Stage I-IIa)
• Low-grade mOC
  OR
• Early EC (FIGO Stage I-II)

Your contacts: Investigators at the center and contact information

Dr. Andriana Haus

Email: haus@~@gp-ruesselsheim.de

Phone: 06142 88-1316

Staff members responsible at the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032