Cervical cancer studies run on radiotherapy as much as drugs: external beam, brachytherapy, concurrent cisplatin and the toxicity that follows. Capture holds the treatment log, staging, RECIST response and survival follow-up in one study. Free sandbox, no credit card, pay only at go-live.
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| Assessment | Screen | CRT wk 1-5 | Brachy | Wk 12 | Mo 6 | Q3M FU |
|---|---|---|---|---|---|---|
| External beam radiotherapy | ||||||
| Concurrent cisplatin | ||||||
| Brachytherapy | ||||||
| Pelvic exam and imaging response | ||||||
| Toxicity grading | ||||||
| Survival status |
x = visit form; CRT = chemoradiotherapy
What a cervical cancer trial needs from its EDC
The study data
Cervical cancer trials fall into three families. Locally advanced disease (FIGO stage IB3 to IVA) is treated with concurrent cisplatin-based chemoradiotherapy followed by brachytherapy, and recent trials add immunotherapy: KEYNOTE-A18, with 1,060 participants at 176 centres in 30 countries, used progression-free survival and overall survival as dual primary endpoints for pembrolizumab with chemoradiotherapy, reported a benefit that was concentrated in stage III to IVA disease, and led to FDA approval in January 2024. Treat this as an example of how the endpoints are built rather than as guidance for your protocol.
Persistent, recurrent or metastatic disease uses systemic therapy, including checkpoint inhibitors and antibody-drug conjugates, and the endpoints are the familiar solid-tumour set: overall survival, progression-free survival and objective response by RECIST 1.1. Each assessment needs target lesion rows with sizes, non-target status, new lesions and an overall response, which a table section handles well. See EDC for ovarian cancer trials for how a gynaecologic neighbour handles response and EDC for oncology clinical trials for the general model.
Pre-invasive disease is another study altogether. Therapeutic HPV vaccine and topical agent trials in CIN2/3 usually measure histological regression and HPV clearance, with colposcopy, biopsy and HPV genotyping on fixed visits. Participants are younger, pregnancy status matters, and the visit schedule is a handful of clinic visits plus a symptom diary. Same platform, completely different forms.
Overall treatment time is an important quality variable in cervical chemoradiotherapy, so the log should capture fraction dates, dose per fraction, total dose, cisplatin cycles and any interruptions with reasons. A table section holds one row per fraction or per brachytherapy application, and a calculated field can derive days between first and last treatment from the date entries. Dose planning data stays in the radiotherapy system; the EDC holds the delivered summary the protocol asks for.
External beam
First fraction
RTSTDTLast fraction
RTENDTTotal dose delivered
RTDOSEInterruption of 3+ days
RTINTReason required when Yes
Concurrent chemotherapy
Cisplatin cycles given
CISCYCCreatinine clearance before cycle 1
CRCLCockcroft-Gault, read-only
74 mL/min CalculatedProtocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Baseline disease | FIGO stage, histology, nodal status, HPV status | Disease history form; medical history eCRF as a start |
| Chemoradiotherapy | Fractions, dose, interruptions, cisplatin cycles | Treatment log with repeating rows |
| Brachytherapy | Applications, technique, dose | Repeating table, one row per application |
| Tumour response | Target lesions, non-target, new lesions, overall response | RECIST-style response form with lesion table; no automatic response call |
| Survival follow-up | Date of progression, new therapy, last known alive, death | Follow-up form; status chased by site coordinators |
| Performance status | ECOG each cycle | ECOG eCRF |
| Late toxicity | GI, urinary, vaginal, lymphoedema grade | Adverse event form with CTCAE |
| Quality of life | Sexual and bowel function, general QoL | Participant questionnaires; licences stay with study documents |
Staging systems and response criteria are updated over time. Build to the version your protocol cites.
Build the chemoradiation and brachytherapy forms in the free sandbox and test them with real fraction data. No credit card.
Safety and quality of life
Acute toxicity during chemoradiation is mostly haematological, gastrointestinal and renal, and the safety dataset links laboratory values to cisplatin dosing: creatinine clearance, neutrophils, platelets, haemoglobin and magnesium. Capture can calculate Cockcroft-Gault clearance from entered values. Late toxicity from bowel, bladder and vaginal effects appears months to years later, which is why follow-up forms should stay open well after treatment ends. Grade events by CTCAE if your protocol does, and route serious events through the SAE workflow.
Patient-reported outcomes matter because the clinic grade often understates what women experience. A symptom diary or questionnaire completed from a secure phone link, with reminders, captures bowel, urinary and sexual function across follow-up; see oncology side effect diary ePRO for a layout and best ePRO for oncology trials for the wider picture. Any licensed instrument remains licensed through its rights holder.
Build sequence
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External beam, cisplatin and brachytherapy tables with interruption reasons.
Lesion table, overall response and imaging date, with imaging-window checks.
Scheduled contact forms with last-known-alive date and cause of death fields.
eConsent for each site; QR-code enrolment and site numbering.
Run practice participants through the schedule, approve forms, and go live.
Delivery
A high share of cervical cancer cases occur in low- and middle-income countries, so many trials recruit across Asia, Africa and Latin America as well as Europe and North America. Capture runs in the browser; data is hosted in the EU (Frankfurt) or the USA (N. Virginia), and participant consent can be signed on a tablet or phone with an email one-time code and countersigned by the investigator. Capture does not currently list multilingual questionnaires or consent, so plan translated documents outside the product.
Survival follow-up for years after treatment is the largest recurring workload. Visit windows, reminder tasks for site coordinators and by-site filtering of overdue contacts help sites keep survival status complete. See multi-site clinical trial management and EDC for Phase 3 trials.
Yes, in table sections with one row per fraction or application. Planning data stays in the radiotherapy system; the EDC holds the delivered summary your protocol requires.
No. The response form holds lesion measurements and your assessor's overall response; response calls are not generated by the system.
It records progression and survival status with dates for analysis. Time-to-event methods run on exported data.
Yes, with colposcopy, biopsy and HPV genotyping forms on a short visit schedule and a participant diary if required.
Not currently listed as available; plan translated documents outside the product.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, including multi-country designs.
Free sandbox with every feature, no credit card; you pay at go-live. See the pricing page.
Keep exploring
EDC for oncology clinical trials
General oncology model.
EDC for ovarian cancer trials
Gynaecologic neighbour.
Oncology side effect diary ePRO
Symptom diary layout.
ECOG performance status eCRF
Performance status form.
Best ePRO for oncology trials
Patient-reported outcomes in cancer.
Pricing
Plans for live studies.
Free sandbox with every feature. No credit card, and you pay only when you go live.