Ensayos clínicos

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 OR a single radiologically-abnormal inguinal lymph node with no evidence of extra-nodal extension), M0 or;
  • any T, N2 (i.e., palpable mobile multiple or bilateral inguinal lymph nodes OR radiologically evident multiple or bilateral inguinal nodes with no evidence of extra-nodal extension), 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 (InPACT-neoadjuvant only).
• 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 InPACT-neoadjuvant but may be considered for arm A.
• Patients being considered for InPACT-neoadjuvant must fulfil additional eligibility criteria.
• Patients being considered for InPACT-pelvis must fulfil additional eligibility criteria.
• Willing and able to comply with follow-up schedule.
•  Written informed consent.

Exclusion Criteria:

• 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.
• Any absolute contraindication to chemotherapy if eligible for a chemotherapy/chemoradiotherapy randomisation.
• 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).
• Radiological evidence of macroscopic pelvic lymph node disease on post-ILND cross-sectional imaging.
• Patients with regionally advanced (N1-3, M0) penile cancer with disease burden that is considered unresectable by the credentialed InPACT surgeon* utilising standard inguinal, ilioinguinal lymphadenectomy resection and reconstructive techniques. For example, where procedures would require circumferential resection of the femoral or iliac vessels, or the requirement for hemipelvectomy.

* InPACT surgeon should consider reviewing the case with their National InPACT surgical lead where resectablity is unclear.