Clinical trial NCT02305654: International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
Official title: International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of the Penis, Usual Type
Keywords: Penis cancer
Chemotherapy
Chemoradiotherapy
Surgery
Phase III
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: ECOG-ACRIN Cancer Research Group
First posted: 2014-12-02
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: up to 5 years
Secondary outcomes:
measure: Disease specific survival time
timeFrame: up to 5 years
measure: Number of patients experience a grade 3 or 4 toxicity
timeFrame: up to 5 years
measure: Disease-free survival time
timeFrame: up to 5 years
measure: Occurrence of surgical complication
timeFrame: up to 5 years
measure: Is it possible to achieve pathological nodal assessment after chemotherapy
timeFrame: 12 weeks
measure: Quality of life
timeFrame: Baseline, 3, 6, 9, 12, 18, 24 and 36 months
measure: Occurrence of Pathological complete remission
timeFrame: Time to complete remission after randomisation
measure: Operability
timeFrame: 2-6 weeks
measure: Occurrence of Lower limb/scrotal oedema
timeFrame: up to 5 years
measure: On-schedule delivery of neoadjuvant therapy
timeFrame: After randomisation up to 12 weeks
Other outcomes:
measure: Acceptability of randomisation
timeFrame: up to 5 years
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
city: Cardiff
country: United Kingdom
facility: Velindre NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's Hospital NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
city: Swansea
country: United Kingdom
facility: Swansea Bay University Health Board
Study officials:
affiliation: Mid and South Essex NHS Foundation Trust
name: Steve Nicholson
role: STUDY_CHAIR
affiliation: University of Texas M.D. Anderson Cancer Center ; 713-792-3250 ; cpettawa@mdanderson.org
name: Curtis Pettaway
role: STUDY_CHAIR
References: