Trial · NCT02305654
International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
NCT02305654, Phase 3, Active not recruiting, Institute of Cancer Research, United Kingdom
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study). Trials, record NCT02305654. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02305654
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
- NCT number
- NCT02305654
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 200 participants, estimated
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Conditions
- Squamous Cell Carcinoma of the Penis, Usual Type
- Interventions
- ILND - Inguinal Lymph Node Dissection, Paclitaxel, Ifosfamide, Cisplatin, Intensity modulated radiation treatment (IMRT), Prophylactic PLND - pelvic lymph node dissection
- First posted
- 2014-12-02
- Last updated
- 2026-08-31
- Other registries' IDs
- eudract:2015-001199-23, isrctn:ISRCTN13580965
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival | up to 5 years | The primary outcome measure that will be measured for all trial patients is survival time. This is 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 | Disease specific survival time | up to 5 years | Disease-specific survival time which is defined in whole days as the time from the date of randomisation to the date of death specifically from disease; 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. |
| Secondary | Number of patients experience a grade 3 or 4 toxicity | up to 5 years | |
| Secondary | Disease-free survival time | up to 5 years | Disease-free survival time (DFST) which is defined in whole days as the time from date of randomisation to the date of either locoregional recurrence, distant metastasis or death from disease, whichever occurs first; for those who have not been reported as experiencing any of these events, the DFST 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. Subsidiary outcome measures will be * locoregional recurrence free survival time (LRFST). * distant metastases free survival time (DMFST). * 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. |
| Secondary | Occurrence of surgical complication | up to 5 years | |
| Secondary | Is it possible to achieve pathological nodal assessment after chemotherapy | 12 weeks | Feasibility of pathological nodal assessment after chemotherapy which is recorded as whether or not it was possible to achieve a pathological nodal assessment after chemotherapy. |
| Secondary | Quality of life | Baseline, 3, 6, 9, 12, 18, 24 and 36 months | Measured using the EORTC-QLQC30 and Lymphodema-QL |
| Secondary | Occurrence of Pathological complete remission | Time to complete remission after randomisation | Measured for all patients in InPACT-neoadjuvant: Absolute absence of disease on histological examination |
| Secondary | Operability | 2-6 weeks | Measured for all trial patients in InPACT-neoadjuvant. Operability which will be recorded as whether or not the planned inguinal node dissection was undertaken and the reasons if it did not occur. |
| Secondary | Occurrence of Lower limb/scrotal oedema | up to 5 years | Occurrence of Lower limb/scrotal oedema which is recorded as whether or not the patient experiences a lower limb or scrotal oedema |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02305654
GET https://conductscience.org/api/trials/v1/NCT02305654/registered