EDC for ovarian cancer clinical trials

Ovarian cancer protocols cover a spread of settings: first-line treatment after surgery, maintenance therapy after response to platinum, and relapsed disease split by how long since the last platinum. Progression-free survival is a frequent primary endpoint, often judged by the investigator using RECIST 1.1 on imaging. The shape of the data therefore depends on the setting, but nearly every design asks for baseline disease, prior therapy, scans on a fixed interval and a running toxicity record.

What makes the indication distinctive is CA-125. The Gynecologic Cancer InterGroup (GCIG) criteria let a rising CA-125 count as progression, and registered protocols describe it in terms such as a value at least twice the upper limit of normal on two occasions a week apart, or twice the nadir if the baseline was elevated. Some trials define a combined progression-free survival from RECIST and CA-125 together, while others use RECIST alone for the primary and analyse CA-125 separately. Published work has also discussed how well the two agree in participants on PARP inhibitor maintenance. For the EDC, the practical conclusion is simple: capture the CA-125 value, unit, sample date and reference limit on its own form, and capture the scan result on another.

Biomarker status is the second pillar. BRCA mutation status and HRD status are used to define or stratify cohorts in PARP inhibitor trials, and analyses report progression-free survival by these subgroups. Record the result, the test, the sample date and whether it is germline or tumor-derived as separate fields, and add an edit check so a participant cannot be randomized to a biomarker-defined cohort without a result on file.

Ovarian regimens carry their own safety profile. Platinum and taxane chemotherapy bring neutropenia, neuropathy and hypersensitivity reactions, and oral maintenance agents commonly bring anemia, nausea, fatigue and other cumulative effects over months. Which events must be graded every cycle is a protocol decision. Whatever the list, each event needs a CTCAE grade, seriousness, relationship and the action taken, and the form should distinguish a dose interruption from a dose reduction because dose intensity is often analysed.

Because maintenance can last many months, a short patient-reported check between visits often catches fatigue and gastrointestinal symptoms earlier than a three-weekly clinic visit. A phone questionnaire opens from a secure link with no app, and the PRO-CTCAE form structure is one place to start thinking about symptom items. Treat the diary as supporting data for the investigator and not as a replacement for assessment.

For serious events, the SAE report form and the SAE reporting deadline calculator support the reporting clock. Check term and grade wording with the CTCAE grade lookup; the investigator still assigns the grade.