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International Penile Advanced Cancer Trial (InPACT)

This study is for men aged 18 and older with advanced squamous cell carcinoma of the penis that has spread to the lymph nodes in the groin. Researchers are comparing different treatment approaches, including surgery (Inguinal Lymph Node Dissection), chemotherapy drugs like Paclitaxel, Ifosfamide, and Cisplatin, and radiation therapy (Intensity Modulated Radiation Treatment or IMRT). The main goal is to see which treatments lead to better overall survival, measured up to 5 years. This is an international study, and the current recruitment status is unclear.

Study design
This is an international Phase III interventional study with a Bayesian design, involving two sequential randomizations. It plans to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for overall survival, measured at up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02305654

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Institute of Cancer Research, United Kingdom
~200 participants
Updated 2025-04-02 on ClinicalTrials.gov
What's tested:ILND - Inguinal Lymph Node DissectionPaclitaxelIfosfamideCisplatinIntensity modulated radiation treatment (IMRT)Prophylactic PLND - pelvic lymph node dissection

At a glance

Recruiting sites
10 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival
Measured over up to 5 years

Conditions

Squamous Cell Carcinoma of the Penis, Usual Type

Explore related trials

Penile Carcinoma

Where it's being run

17 sites across 10 states
United Kingdom6
California2
Georgia2
Florida1
Illinois1
Minnesota1
Ohio1
Oklahoma1

Study leadership

  • 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 ; [email protected]

Who to contact

UK - InPACT Senior Trial Manager
[email protected]
02087224261
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Overall survivalup to 5 years

    The primary outcome measure that will be measured for all trial patients is survival time. This is defined in whole days as the time from the date of randomisation to the date of death from any cause; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up.