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

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

Condition: Squamous Cell Carcinoma of the Penis, Usual Type

Intervention:

  • Procedure: ILND – Inguinal Lymph Node Dissection
  • Drug: Paclitaxel
  • Drug: Ifosfamide
  • Drug: Cisplatin
  • Radiation: Intensity modulated radiation treatment (IMRT)
  • Procedure: Prophylactic PLND – pelvic lymph node dissection

Purpose: 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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02305654

Sponsor: Institute of Cancer Research, United Kingdom

Primary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: up to 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Disease specific survival time
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Number of patients experience a grade 3 or 4 toxicity
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Disease-free survival time
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Occurrence of surgical complication
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Is it possible to achieve pathological nodal assessment after chemotherapy
  • Time Frame: 12 weeks
  • Safety Issue:
  • Measure: Quality of life
  • Time Frame: Baseline, 3, 6, 9, 12, 18, 24 and 36 months
  • Safety Issue:
  • Measure: Occurrence of Pathological complete remission
  • Time Frame: Time to complete remission after randomisation
  • Safety Issue:
  • Measure: Operability
  • Time Frame: 2-6 weeks
  • Safety Issue:
  • Measure: Occurrence of Lower limb/scrotal oedema
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: On-schedule delivery of neoadjuvant therapy
  • Time Frame: After randomisation up to 12 weeks
  • Safety Issue:

Estimated Enrollment: 400

Study Start Date: May 12, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. Written informed consent 2. Measurable disease as determined by RECIST (version 1.1) criteria; 3. Histologically-proven squamous cell carcinoma of the penis, 4. 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 5. Performance Status ECOG 0, 1 or 2.

Exclusion Criteria:

  1. Pure verrucous carcinoma of the penis,
  2. Nonsquamous malignancy of the penis,
  3. Squamous carcinoma of the urethra,
  4. Stage M1,
  5. Previous chemotherapy or chemoradiotherapy,
  6. 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.

Contact:

  • InPACT Senior Trial Manager
  • 02087224261

Locations:

  • The Royal Marsden NHS Foundation Trust
  • London SM2 5PT United Kingdom
  • St George’s Hospital NHS Foundation Trust
  • London SW17 0QT United Kingdom

View trial on ClinicalTrials.gov

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