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

Overview

About this study

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions. InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments: A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND). After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either: P. prophylactic PLND Q. no prophylactic PLND

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lance Pagliaro, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20385605

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