International penile advanced cancer trial - an International Rare Cancers Initiative study
Disease site: Penile cancer, urological cancers
Treatment modalities: Combinations of surgery, neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy and adjuvant chemoradiotherapy.
Status: Open to recruitment
InPACT is an international phase III trial with a Bayesian design incorporating two sequential randomisations (InPACT-neoadjuvant and InPACT-pelvis) in patients with squamous carcinoma of the penis who have inguinal lymph node metastases (i.e. locally advanced disease). InPACT aims to determine:
- If there is a role for neoadjuvant therapy in this patient group; and
- If prophylactic pelvic lymph node dissection (PLND) improves survival in patients at high risk of recurrence following inguinal lymph node dissection (ILND).
400 patients will be recruited (200 from UK sites; 200 US & European sites) over a 5 year period. In randomisation 1 (InPACT-neoadjuvant), dependent on disease burden strata, patients are allocated to one of three initial treatment arms:
- Standard surgery (ILND) – no neoadjuvant treatment;
- Neoadjuvant chemotherapy followed by ILND; or
- Neoadjuvant chemoradiotherapy followed by ILND.
In randomisation 2 (InPACT-pelvis), patients at high risk of relapse (based on histological interpretation of the ILND specimen) are randomised to either:
- Prophylactic PLND; or
- No prophylactic PLND (surveillance).
Patients in both arms will also receive adjuvant chemoradiotherapy, if not already received in the neoadjuvant setting.
- Dr Steve Nicholson (Study Chair), c/o ICR-CTSU
- Dr Curtis Pettaway (US Co-Chair), MD Anderson Cancer Centre, Houston, TX, USA
- Mr Nick Watkin (National Coordinator for the UK), St George’s Healthcare NHS Trust
ICR-CTSU Scientific Lead: Prof Emma Hall
Trial management contact: [email protected]
UK Sponsor: The Institute of Cancer Research
US Sponsor: ECOG-ACRIN
Funding: Cancer Research UK (CRUK/13/005)
View InPACT on the UK Clinical Trials Gateway.
Read a plain English summary of InPACT from Cancer Research UK.
Publications and presentations
There have been no presentations or publications to date.
This research was funded by the Stand Up to Cancer campaign for Cancer Research UK