Does Palliative Chemotherapy Improve Symptoms in Women with Recurrent Ovarian Cancer? Measuring subjective improvement as well as objective response to estimate the benefit of palliative chemotherapy in women with platinum resistant or refractory ovarian cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010250

Enrollment

800

Registered

2013-03-15

Start date

2012-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with platinum resistant/refractory ovarian cancers who are about to start 2nd or subsequent line chemotherapy

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Age>=18 years 2) Clinical diagnosis of epithelial ovarian, peritoneal or fallopian tube cancers 3) Recurrent or progressive disease (CA125, radiological or clinical) 4) ECOG PS 0-3 5) Life expectancy > 3 months 6) Planning to start chemotherapy within 2weeks of registration 7) Able to complete questionnaires independently.

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
A clinically significant difference as determined by changes in subjective symptoms, objective responses and QoL scores from baseline to post treatment assessment	—

Secondary

Measure	Time frame
1. The proportion of patients experiencing a clinically significant improvement in symptoms 2. Reason for treatment: (a) symptomatic, (b) rising tumor markers alone, or (c) have imaging evidence of disease progression 3. Symptoms rated most severe by patients 4. HRQL scores at baseline, during and after post treatment 5. Causes of major symptoms: ie, predominantly treatment-related, predominantly disease related, or potentially caused by both treatment and disease) 6. Objective tumor response as measured by RECIST or GCIG criteria for CA 125 response 7. Time to symptom deterioration 8. Duration of symptom improvement 9. Time to disease progression 10. Time to death	—

Measure

Time frame

1. The proportion of patients experiencing a clinically significant improvement in symptoms 2. Reason for treatment: (a) symptomatic, (b) rising tumor markers alone, or (c) have imaging evidence of disease progression 3. Symptoms rated most severe by patients 4. HRQL scores at baseline, during and after post treatment 5. Causes of major symptoms: ie, predominantly treatment-related, predominantly disease related, or potentially caused by both treatment and disease) 6. Objective tumor response as measured by RECIST or GCIG criteria for CA 125 response 7. Time to symptom deterioration 8. Duration of symptom improvement 9. Time to disease progression 10. Time to death

—

Countries

Japan,North America,Australia,Europe

Outcome results