An international study looking at the treatment of cancer of the penis that has spread to inguinal or pelvic lymph nodes

Not Applicable

• Conditions: Penis cancer; Cancer

• Registration Number: ISRCTN13580965
• Lead Sponsor: Institute of Cancer Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-13
• Last Update Posted: 18 June 2024
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 249

Inclusion Criteria

1. Male, aged 18 years or older
2. Histologically-proven squamous cell carcinoma of the penis
3. Stage:
3.1. Any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or
3.2. Any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or
3.3. Any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0
4. Measurable disease as determined by RECIST (version 1.1) criteria
5. Performance Status ECOG 0, 1 or 2
6. Patient is fit to receive the randomisation options for which he is being considered
7. Haematology/biochemistry (as dictated by local hospital practice) should indicate fitness for randomisation options and parameters should be in line with considerations specified in the summary of product characteristics. Haematological parameters should not be supported by transfusion to enable entry into the trial. Liver function and renal function tests must form part of the pre-treatment assessment for patients who may be randomised to receive TIP chemotherapy e.g. patients with impaired renal function may not be considered for arms B and C of InPACT-neoadjuvant but may be considered for arm A
8. Willing and able to comply with follow-up schedule
9. Written informed consent

Exclusion Criteria

Patients who have any of the following are not eligible:
1. Pure verrucous carcinoma of the penis
2. Non-squamous malignancy of the penis
3. Squamous carcinoma of the urethra
4. Stage M1
5. Previous chemotherapy or chemoradiotherapy outside of the InPACT trial
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
7. Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile)

Study & Design

• Study Type: Interventional
• Study Design: Not specified