RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2017-05-12
Study Completion:2027-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02305654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Written informed consent
  2. 2. Measurable disease as determined by RECIST (version 1.1) criteria;
  3. 3. Histologically-proven squamous cell carcinoma of the penis,
  4. 4. Stage:
  5. * any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;
  6. * any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or;
  7. * any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0
  8. 5. Performance Status ECOG 0, 1 or 2.
  1. 1. Pure verrucous carcinoma of the penis,
  2. 2. Nonsquamous malignancy of the penis,
  3. 3. Squamous carcinoma of the urethra,
  4. 4. Stage M1,
  5. 5. Previous chemotherapy or chemoradiotherapy,
  6. 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.

Contacts and Locations

Study Contact

UK - InPACT Senior Trial Manager
CONTACT
02087224261
InPACT-icrctsu@icr.ac.uk
US/Canada - InPACT DA for EA8134
CONTACT
(857)504-2900

Principal Investigator

Steve Nicholson
STUDY_CHAIR
Mid and South Essex NHS Foundation Trust
Curtis Pettaway
STUDY_CHAIR
University of Texas M.D. Anderson Cancer Center ; 713-792-3250 ; cpettawa@mdanderson.org

Study Locations (Sites)

Los Angeles County-USC Medical Center
Los Angeles, California, 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Grady Health System
Atlanta, Georgia, 30303
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Institute of Cancer Research, United Kingdom

  • Steve Nicholson, STUDY_CHAIR, Mid and South Essex NHS Foundation Trust
  • Curtis Pettaway, STUDY_CHAIR, University of Texas M.D. Anderson Cancer Center ; 713-792-3250 ; cpettawa@mdanderson.org

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-05-12
Study Completion Date2027-11-30

Study Record Updates

Study Start Date2017-05-12
Study Completion Date2027-11-30

Terms related to this study

Keywords Provided by Researchers

  • Penis cancer
  • Chemotherapy
  • Chemoradiotherapy
  • Surgery
  • Phase III

Additional Relevant MeSH Terms

  • Squamous Cell Carcinoma of the Penis, Usual Type