An international study looking at the treatment of cancer of the penis that has spread to inguinal or pelvic lymph nodes

Survival time, defined in whole days as the time from the date of randomisation to the date of death from any cause; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up.

Secondary outcome measures for all patients:
1. Disease-specific survival time, defined in whole days as the time from the date of randomisation to the date of death specifically from penis cancer; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up and for those whose death is reported as non-disease specific then the survival time will be censored at date of death
2. Disease-free survival time (DFS), defined in whole days as the time from date of randomisation to the date of either locoregional recurrence, distant metastasis or death from penis cancer, whichever occurs first; for those who have not been reported as experiencing any of these events, the DFS time will be censored at the date last known to be alive and free of disease or date of non-disease-specific death. A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin rather than date of randomisation. A subsidiary outcome measure will be locoregional recurrence free survival time (LRFST) which is defined in whole days as the time from date of randomisation to the date of locoregional recurrence; for those who have not been reported with this event, the LRFST will be censored at the date last known to be alive and free of disease
3. A subsidiary outcome measure will be distant metastases free survival time (DMFST), defined in whole days as the time from date of randomisation to the date of distant metastasis or death from disease, whichever occurs first; for those who have not been reported as experiencing either of these events, the DMFST will be censored at the date last known to be alive and free of distant metastasis or date of non-disease-specific death. A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin for all these outcome measures rather than date of randomisation
4. Toxicity; all events experienced by patients are recorded and graded using CTCAE Version 4 criteria and specifically the occurrence of at least one grade 3 or 4 event
5. Occurrence of surgical complications, recorded as whether or not a surgical complication was experienced according to the Modifed Clavien-Dindo Classification criteria
6. Feasibility of pathological nodal assessment after chemotherapy, recorded as whether or not it was possible to achieve a pathological nodal assessment after chemotherapy
7. Quality of life (in participating patients), measured using the EORTC-QLQC30 and Lymphodema-QL on 8 occasions: prior to randomisation, 3-monthly during year 1, 6-monthly during year 2, and at the end of year 3

Secondary outcome measures measured for all trial patients in InPACT-neoadjuvant:
1. Occurrence of pathological complete remission, defined as an absolute absence of disease on histological examination in accordance with the Royal College of Pathologists’ guidelines
2. Operability, recorded as whether or not the planned inguinal node dissection was undertaken and the reasons if it did not occur
3. Feasibility of on-schedule delivery of neoadjuvant therapy

Secondary outcome measures for all trial patients in InPACT-pelvis:
1. Occurrence of lower limb/scrotal oedema, recorded as whether or not the patient experiences a lower limb or scrotal oedema according to CTCAE Version 4 criteria