trialsTrialActive

InPACT

aka International Penile Advanced Cancer Trial, EA8134, IRCI004

InPACT is the first international trial in penile cancer that has spread to the groin nodes; it tests whether chemotherapy or chemoradiotherapy before removing the nodes, and preventive removal of pelvic nodes afterwards, help people live longer, and it is the reason chemoradiotherapy is offered within the trial as an alternative to chemotherapy.

InPACT is an International Rare Cancers Initiative phase 3 trial led by the Institute of Cancer Research with ECOG-ACRIN and the National Cancer Institute, using a Bayesian multi-arm design in about 200 patients with node-positive penile squamous cell carcinoma. The first randomisation compares standard inguinal lymph node dissection with neoadjuvant TIP chemotherapy or neoadjuvant cisplatin-based chemoradiotherapy before surgery; a second randomisation in patients at high risk of pelvic relapse compares prophylactic pelvic lymph node dissection with surveillance. The primary endpoint is overall survival.

The registry lists the trial as active and no longer recruiting with primary completion in 2027 and no results. The corpus's node-positive penile cancer page cites InPACT for chemoradiotherapy as an alternative to neoadjuvant chemotherapy within the trial.

Setting

Penile squamous cell carcinoma with inguinal lymph node involvement: a Bayesian multi-arm trial randomising between immediate inguinal node dissection, neoadjuvant paclitaxel, ifosfamide and cisplatin (TIP) then surgery, and neoadjuvant cisplatin chemoradiotherapy then surgery, with a second randomisation to prophylactic pelvic node dissection or surveillance in high-risk patients, and overall survival as the primary endpoint

Phase

Phase 3

Sponsor

Institute of Cancer Research, United Kingdom

Registry

NCT02305654

Enrolled

200 enrolled