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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Stephanie Burnett
+44 (0)20 8722 4261
inpact-icrctsu@icr.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - An international study looking at the treatment of cancer of the penis that has spread to inguinal or pelvic lymph nodes
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An international study looking at the treatment of cancer of the penis that has spread to inguinal or pelvic lymph nodes

Recruiting

Open to: Male

Age: Adult

Cardiff Sutton Leicester London Norwich Swansea

Medical Conditions

Penis cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 May 2017 31 May 2025

Publications

2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/31160252/ (added 10/05/2022)

Interventional

Intervention Type : Mixed
Intervention Description : Patients will receive up to 4 treatments in different sequences. Randomisation process: Sequential randomisation by minimisation.

Treatment 1: Inguinal lymph node dissection (ILND)Methodology: Standard of care surgery performed utilizing open approachTotal duration of treatment: 1 day

Treatment 2: ChemotherapyMethodology: neoadjuvant chemotherapy before surgery (ILND)Generic drug name: Paclitaxel, Ifosfamide, Cisplatin (TIP)The dosage given: Paclitaxel 175 mg/m²/cycle, Ifosfamide 3600 mg/m²/cycle, Cisplatin 75 mg/m²/cycleMethod of administration: Intravenous infusionFrequency of administration: The inpatient regimen of TIP is administered over 3 days repeated in 21-day cycles. The outpatient regimen is administered over 5 days repeated in 21-day cyclesTotal duration of treatment: 12 weeks (4 21-day cycles)

Treatment 3: ChemoradiotherapyMethodology: neoadjuvant chemoradiotherapy before surgery (ILND) OR adjuvant chemoradiotherapy after pelvic lymph node dissectionGeneric drug name: CisplatinThe dosage given: Concurrent cisplatin at 40 mg/m² weeklyRadiotherapy in the neoadjuvant setting: the radiotherapy dose is 45Gy in 25 fractions over 5 weeks using 6-10 MV photons to all regions.Radiotherapy in the adjuvant setting: Groin: One or both groins may be boosted up to 54Gy in 25 fractions. An IMRT boost of up to 57 Gy can be given to recurrent or residual macroscopic tumourPelvis: An IMRT boost of up to 54Gy in 25 fractions is applied to:1. Any macroscopic tumour or pathological lymph nodes2. Electively to external iliac nodes in patient with high disease burdenMethod of administration: Concurrent cisplatin is given via intravenous infusion. Radiotherapy is to be delivered with either a forward planned IMRT technique or inverse planned IMRT, performed using the local treatment planning system. Rotational arc therapies are permitted (Rapid Arc™, VMAT™ and Tomotherapy™).Frequency of administration: Concurrent cisplatin is given once a week, radiotherapy is given 5 days a weekTotal duration of treatment: 5 weeks

Treatment 4: Pelvic lymph node dissectionMethodology: prophylactic pelvic lymph node dissection perforemed utilizing open, laparoscopic or robot-assisted laparoscopic approachesTotal duration of treatment: 1 day

Follow-up: All patients will undergo clinical review in accordance with the guidelines of the European Association of Urology (EAU), namely every 3 months for years 1 and 2, then every 6 months for years 3, 4 and 5, from the start of their treatment




You can take part if:



You may not be able to take part if:


Patients who have any of the following are not eligible: 1. Pure verrucous carcinoma of the penis2. Non-squamous malignancy of the penis3. Squamous carcinoma of the urethra4. Stage M15. Previous chemotherapy or chemoradiotherapy outside of the InPACT trial6. 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 years7. Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Velindre Hospital
    Velindre Road
    Cardiff
    CF14 2TL
  • The Royal Marsden Hospital
    Downs road
    Sutton
    SM2 5PT
  • Leicester General Hospital
    Gwendolen Road
    Leicester
    LE5 4PW
  • St George’s Hospital
    Blackshaw Road
    London
    SW17 0QT
  • Norfolk and Norwich University Hospital
    Colney Lane Colney
    Norwich
    NR4 7UY
  • Morriston Hospital
    Heol Maes Eglwys Cwmrhydyceirw
    Swansea
    SA6 6NL

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Ms Stephanie Burnett
+44 (0)20 8722 4261
inpact-icrctsu@icr.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Institute of Cancer Research and funded by Cancer Research UK.



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Read full details for Trial ID: ISRCTN13580965

Or CPMS 32594

Last updated 03 June 2024

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