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Can adding chemotherapy before surgery beat penile cancer?

NCT ID NCT02305654

Disease control Sponsor: Institute of Cancer Research, United Kingdom Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether giving chemotherapy or chemoradiotherapy before surgery improves survival for people with penile cancer that has spread to lymph nodes in the groin. Participants are randomly assigned to receive standard surgery alone, chemotherapy followed by surgery, or chemoradiotherapy followed by surgery. After surgery, those at high risk of recurrence may be randomized again to receive additional preventive lymph node removal or not. The study aims to find the best sequence of treatments to extend life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of chemotherapy drugs (paclitaxel, ifosfamide, cisplatin) and radiation therapy, given before or after surgery to remove lymph nodes in the groin.
What this could lead to
If it works, this could establish a new standard of care for penile cancer that has spread to the lymph nodes, potentially improving survival rates.
What could go wrong
The trial is large and randomized, but the treatments carry significant side effects, and the results may not apply to all patients with this rare cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2017

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

penile neoplasm squamous cell carcinoma of penis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Squamous cell carcinoma of the penis, usual type

Contacts and locations

Locations

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Grady Health System

    Atlanta, Georgia, 30303, United States

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, NR4 7UY, United Kingdom

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • St George's Hospital NHS Foundation Trust

    London, SW17 0QT, United Kingdom

  • Swansea Bay University Health Board

    Swansea, SA6 6NL, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    London, SM2 5PT, United Kingdom

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University Hospitals of Leicester NHS Trust

    Leicester, LE1 5WW, United Kingdom

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Velindre NHS Trust

    Cardiff, CF14 2TL, United Kingdom