Trial · NCT07401654
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of patients with a chemotherapy reaction score of 3 (CRS3) | Perioperative/Periprocedural | |
| Primary | Incidence of grade 3-4 neutropenia | During the 2-year follow-up period, from the start of randomization to the patient's withdrawal from the study | |
| Secondary | Satisfactory tumor reduction rate | Perioperative/Periprocedural | |
| Secondary | R0 resection rate | Perioperative/Periprocedural | |
| Secondary | Surgical complexity | Perioperative/Periprocedural | The measurement that will be used to assess this outcome measure is the Aletti Surgical Complexity Score (SCS), also known as the Surgical Complexity Scoring System for advanced ovarian cancer. This validated scoring system quantifies the complexity of cytoreductive surgery by assigning a weighted point value to specific surgical procedures performed within three anatomical compartments (upper abdomen, mid abdomen, and pelvis). Procedures such as bowel resection, diaphragmatic surgery, splenectomy, and extensive peritonectomy contribute to a total score, which categorizes the surgical effort as low, intermediate, or high complexity. |
| Secondary | Progression-free survival (PFS) | During the 2-year follow-up period, the time elapsed from the start of randomization to disease progression or death | |
| Secondary | Objective response rate (ORR) | During the 2-year follow-up period, from patient randomization to the tumor volume reduction reaching 30% | |
| Secondary | Incidence of platinum resistance in first recurrence | After the treatment, the disease recurred within 6 months | |
| Secondary | Overall survival (OS) | During the 2-year follow-up period, the time elapsed from randomization to death | |
| Secondary | Quality of Life (QoL) | During the 2-year follow-up period, from the beginning of randomization to the end of the study | Quality of Life, measured by the European Organisation for Research and Treatment of Life Questionnaire-Core 30 (EORTC QLQ-C30), version 3.0 (score range: 0-100; higher scores in global health status/functional scales indicate better quality of life, whereas higher scores in symptom scales indicate worse symptoms) and the ovarian cancer-specific module 28-item (QLQ-OV28) questionnaire. Data will be collected via paper-based questionnaires before treatment initiation and during treatment, and via paper-based questionnaires or telephone interviews during the survival follow-up period. The assessment will be terminated upon patient death, withdrawal of informed consent, or upon disease recurrence or metastasis (regardless of whether the randomly assigned treatment is discontinued). |
| Secondary | Incidence of treatment-related adverse events (TRAEs) | During the 2-year follow-up period, from the time of randomization to the time when the patient was discharged from the study |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07401654/registered