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

PHASE3RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

May 12, 2017

Primary Completion Date

May 31, 2027

Study Completion Date

November 30, 2027

Conditions
Squamous Cell Carcinoma of the Penis, Usual Type
Interventions
PROCEDURE

ILND - Inguinal Lymph Node Dissection

Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.

DRUG

Paclitaxel

Dose 175mg/m2 as part of TIP regimen.

DRUG

Ifosfamide

Dose 900mg/m2 as part of TIP regimen.

DRUG

Cisplatin

Dose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)

RADIATION

Intensity modulated radiation treatment (IMRT)

Treatment with very high energy X-rays (radiotherapy).

PROCEDURE

Prophylactic PLND - pelvic lymph node dissection

Surgery to remove the lymph nodes deeper in the pelvis, further away from where the cancer first appeared, that are at high risk of harbouring cancer.

Trial Locations (17)

19111

ACTIVE_NOT_RECRUITING

Fox Chase Cancer Center, Philadelphia

30303

ACTIVE_NOT_RECRUITING

Grady Health System, Atlanta

30322

RECRUITING

Emory University Hospital/Winship Cancer Institute, Atlanta

33612

RECRUITING

Moffitt Cancer Center, Tampa

43210

ACTIVE_NOT_RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

55905

RECRUITING

Mayo Clinic, Rochester

60637

ACTIVE_NOT_RECRUITING

University of Chicago Comprehensive Cancer Center, Chicago

73104

ACTIVE_NOT_RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

77030

RECRUITING

University of Texas M.D. Anderson Cancer Center, Houston

90033

RECRUITING

Los Angeles County-USC Medical Center, Los Angeles

RECRUITING

USC / Norris Comprehensive Cancer Center, Los Angeles

CF14 2TL

RECRUITING

Velindre NHS Trust, Cardiff

LE1 5WW

RECRUITING

University Hospitals of Leicester NHS Trust, Leicester

SM2 5PT

ACTIVE_NOT_RECRUITING

The Royal Marsden NHS Foundation Trust, London

SW17 0QT

RECRUITING

St George's Hospital NHS Foundation Trust, London

NR4 7UY

RECRUITING

Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich

SA6 6NL

ACTIVE_NOT_RECRUITING

Swansea Bay University Health Board, Swansea

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

lead

Institute of Cancer Research, United Kingdom

OTHER