InPACT

• Research type

  Research Study

• Full title

  InPACT - International Penile Advanced Cancer Trial (International Rare Cancer Initiative)

• IRAS ID

  168344

• Contact name

  Stephanie Burnett

• Contact email

  InPACT-icrctsu@icr.ac.uk

• Sponsor organisation

  The Institute of Cancer Research

• Eudract number

  2015-001199-23

• Clinicaltrials.gov Identifier

  NCT02305654

• Duration of Study in the UK

  10 years, 0 months, 1 days

• Research summary

  Penis cancer is a rare disease with a limited body of evidence on which to base the majority of management decisions. In 2011, 558 new cases of penis cancer were registered. Spread to lymph nodes in the groins and the pelvis is the most important prognostic factor: around 80% of patients who have a single involved lymph node in the groin will be alive at 5 years, but only 10% of patients who have involved deeper pelvic lymph nodes will survive.
  Conventional treatment for patients with positive groin nodes is surgery to remove all the affected nodes.
  Chemotherapy (CT) given before surgery (neoadjuvant CT) is shown to shrink affected nodes, but the impact of this approach on survival has not been assessed. Use of synchronous chemoRT (radiotherapy given at the same time as CT) has traditionally been in two scenarios: as palliative treatment for patients who are not fit for surgery; and as follow-on (“adjuvant”) therapy following groin dissection where the risk of cancer returning in the groin is high. Neoadjuvant chemoRT is of interest because of the high risk of such “locoregional” recurrence and the subsequent increased risk of death after recurrence; this approach has not been formally tested in penis cancer. This study will address the value, toxicity and deliverability of both neoadjuvant strategies in patients whose cancer has spread to the groin lymph nodes.
  Prophylactic (preventative) removal of lymph nodes in the pelvis is often performed in patients who have a high likelihood of pelvic and distant relapse. The risk of post-operative complications is high, and it is not clear whether this surgery confers any survival benefit over and above adjuvant chemoRT. This study will address whether there is any added benefit from removing the pelvic lymph nodes in addition to adjuvant chemoradiotherapy over adjuvant chemoradiotherapy alone.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  16/LO/1355

• Date of REC Opinion

  23 Sep 2016

• REC opinion

  Further Information Favourable Opinion