InPACT

 Penile Cancer / Posted 1 year ago

International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study) (InPACT)

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.

  • Inclusion Criteria :
    • Male, aged 18 years or older
    • Histologically-proven squamous cell carcinoma of the penis.
    • Stage: - any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or; - any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or; - any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0
    • Measurable disease as determined by RECIST (version 1.1) criteria.
    • Performance Status ECOG 0, 1 or 2.
    • Patient is fit to receive the randomisation options for which he is being considered.
    • Haematology/biochemistry (as dictated by local hospital practice) should indicate fitness for randomisation options and parameters should be in line with considerations specified in the summary of product characteristics. Haematological parameters should not be supported by transfusion to enable entry into the trial. Liver function and renal function tests must form part of the pre-treatment assessment for patients who may be randomised to receive TIP chemotherapy e.g. patients with impaired renal function may not be considered for arms B and C of InPACTneoadjuvant (see section 5.5.2 for full details) but may be considered for arm A.
    • Willing and able to comply with follow-up schedule.
    • Written informed consent.
  • Exclusion Criteria : Patients who have any of the following are not eligible:
    • Pure verrucous carcinoma of the penis.
    • Non-squamous malignancy of the penis.
    • Squamous carcinoma of the urethra.
    • Stage M1.
    • Previous chemotherapy or chemoradiotherapy outside of the InPACT trial.
    • Concurrent malignancy (other than SCC or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 years.
    • Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile)
  • Study start date : 12/05/2017
  • Study end date : 31/01/2021
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Dr James Barber (Velindre), Mr Pradeep Bose (Morriston)
Contact details

Velindre and Morriston HospitalWales Wide inpact-icrctsu@icr.ac.uk www.clinicaltrialsregister.eu

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