International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
NCT ID: NCT02305654
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2017-05-12
2027-11-30
Brief Summary
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InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments:
A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).
After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either:
P. prophylactic PLND Q. no prophylactic PLND
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A - Standard Surgery (ILND)
Part of randomisation 1.
The total treatment duration (Inguinal Lymph Node Dissection (ILND)) is estimated to be over 1 day for those patients allocated to Arm A - standard surgery.
ILND - Inguinal Lymph Node Dissection
Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.
Arm B - neoadjuvant chemotherapy
Part of randomisation 1.
Patients will receive up to 4 cycles of Paclitaxel, Ifosfamide, and Cisplatin (TIP).
Administration on an outpatient basis:
Paclitaxel 175 mg/m2, day 1, Ifosfamide 900 mg/m2, days 2-5, Cisplatin 15 mg/m2, days 1-5
Administration on an inpatient basis:
Paclitaxel 175 mg/m2, day 1, Ifosfamide 1200 mg/m2, days 1-3, Cisplatin 25 mg/m2, days 1-3
Paclitaxel
Dose 175mg/m2 as part of TIP regimen.
Ifosfamide
Dose 900mg/m2 as part of TIP regimen.
Cisplatin
Dose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)
Arm C - neoadjuvant chemoradiotherapy
Part of randomisation 1.
Radiotherapy dose is 45Gy in 25 fractions over 5 weeks using 6-10 MV photons to all regions.
Concurrent cisplatin 40mg/m2 will be given weekly, subject to GFR\>45mls/min.
Cisplatin
Dose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)
Intensity modulated radiation treatment (IMRT)
Treatment with very high energy X-rays (radiotherapy).
Arm P - prophylactic PLND
Part of randomisation 2.
Prophylactic pelvic lymph node dissection (PLND) - The total treatment duration is estimated to be over 1 day.
Patients who have NOT received neoadjuvant chemoradiotherapy will receive adjuvant chemoradiotherapy:
Cisplatin 40mg/m2 will be given weekly, subject to GFR\>45mls/min.
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 tumour
Pelvis: the dose is limited to 45Gy unless IMRT is available. An IMRT boost of up to 54Gy in 25 fractions is applied to:
1. Any macroscopic tumour or pathological lymph nodes
2. Electively to external iliac nodes in patient with high disease burden
Patients who have had neoadjuvant chemoradiotherapy will have prophylactic PLND alone.
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.
Arm Q - Surveillance no prophylactic PLND
no prophylactic PLND Part of randomisation 2.
For patients who have NOT received neoadjuvant chemoradiotherapy:
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 tumour
Pelvis: the dose is limited to 45Gy unless IMRT is available. An IMRT boost of up to 54Gy in 25 fractions is applied to:
Any macroscopic tumour or pathological lymph nodes Electively to external iliac nodes in patient with high disease burden
No interventions assigned to this group
Interventions
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ILND - Inguinal Lymph Node Dissection
Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.
Paclitaxel
Dose 175mg/m2 as part of TIP regimen.
Ifosfamide
Dose 900mg/m2 as part of TIP regimen.
Cisplatin
Dose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)
Intensity modulated radiation treatment (IMRT)
Treatment with very high energy X-rays (radiotherapy).
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Steve Nicholson
Role: STUDY_CHAIR
Mid and South Essex NHS Foundation Trust
Curtis Pettaway
Role: STUDY_CHAIR
University of Texas M.D. Anderson Cancer Center ; 713-792-3250 ; [email protected]
Locations
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Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Velindre NHS Trust
Cardiff, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
St George's Hospital NHS Foundation Trust
London, , United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, , United Kingdom
Swansea Bay University Health Board
Swansea, , United Kingdom
Countries
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Central Contacts
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US/Canada - InPACT DA for EA8134
Role: CONTACT
Facility Contacts
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Dr James Barber
Role: primary
Dr Christopher Kent
Role: primary
Mr Nick Watkin
Role: primary
Mr Vivekanandan Kumar
Role: primary
Related Links
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Other Identifiers
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CRUK/13/005
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
13580965
Identifier Type: REGISTRY
Identifier Source: secondary_id
EA8134
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRCI004
Identifier Type: OTHER
Identifier Source: secondary_id
2015-001199-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ICR CTSU/2014/10048
Identifier Type: -
Identifier Source: org_study_id
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