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Chemotherapy

Multiple Therapies for Advanced Penile Cancer (InPACT Trial)

Phase 3

Recruiting

Research Sponsored by Institute of Cancer Research, United Kingdom

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically-proven squamous cell carcinoma of the penis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

InPACT Trial Summary

This trial is designed to efficiently examine a series of questions that arise when deciding how to treat cancer that has spread to the lymph nodes in the groin area. The study is based on the consensus of international experts on which questions are most important to answer. The trial will provide data to help make future treatment decisions.

Who is the study for?

This trial is for individuals with squamous cell carcinoma of the penis, who have palpable lymph nodes but no distant metastasis (M0), and are in a decent physical state (ECOG 0-2). They must have measurable disease and not have received prior chemo or chemoradiotherapy. Those with pure verrucous carcinoma, urethral cancer, other recent malignancies except certain skin cancers, or non-squamous penile cancer cannot join.Check my eligibility

What is being tested?

The study tests different sequences of treatments for penile cancer. Patients may receive standard surgery alone (ILND), chemotherapy before surgery (neoadjuvant chemotherapy + ILND), or chemoradiotherapy before surgery (neoadjuvant chemoradiotherapy + ILND). High-risk patients post-ILND may also be randomized to get prophylactic pelvic lymph node dissection or not.See study design

What are the potential side effects?

Possible side effects include those from surgical procedures like pain and infection risk; chemotherapy can cause nausea, hair loss, fatigue; radiation might lead to skin irritation and fatigue; cisplatin can cause kidney damage; paclitaxel may trigger joint pains.

InPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with penile squamous cell carcinoma.

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My cancer is at a stage where it has spread to my lymph nodes but not to other parts of my body.

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I can take care of myself and am up and about more than half of my waking hours.

InPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival

Secondary outcome measures

Disease specific survival time

Disease-free survival time

Is it possible to achieve pathological nodal assessment after chemotherapy

+7 more

Other outcome measures

Acceptability of randomisation

InPACT Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Arm P - prophylactic PLNDExperimental Treatment1 Intervention

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: Any macroscopic tumour or pathological lymph nodes Electively to external iliac nodes in patient with high disease burden Patients who have had neoadjuvant chemoradiotherapy will have prophylactic PLND alone.

Group II: Arm C - neoadjuvant chemoradiotherapyExperimental Treatment2 Interventions

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.

Group III: Arm B - neoadjuvant chemotherapyExperimental Treatment3 Interventions

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

Group IV: Arm Q - Surveillance no prophylactic PLNDActive Control1 Intervention

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

Group V: Arm A - Standard Surgery (ILND)Active Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ifosfamide

FDA approved

Paclitaxel

FDA approved

Cisplatin

FDA approved

0 / 3Eligibility criteria met