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Clinical Trial 19319

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT02305654

Phase: Phase III
Principal Investigator: Spiess, Philippe

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or 1-800-679-0775 Learn More

Overview

Study Title

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

Summary

The purpose of this study is to determine if having surgery after chemotherapy or after chemotherapy with radiotherapy is better than having surgery alone and whether having additional surgery to remove the lymph nodes that are further away from where the cancer first appeared is better than not having this additional surgery. Not every participant will receive every study treatment.

Objective

Primary Objective: Two questions regarding the management of patients with locally-advanced squamous carcinoma of the penis are addressed as primary objectives: 1. (a) Is there a role for neoadjuvant therapy and, if so, (b) does chemotherapy or chemoradiotherapy produce superior outcomes (either for survival endpoints or for morbidity/quality of life endpoints)? 2. What is the additional survival benefit of prophylactic pelvic lymph node dissection (PLND) given after neoadjuvant chemoradiotherapy or with adjuvant chemoradiotherapy of the pelvic nodes over and above that of chemoradiotherapy alone in patients at high risk of recurrence following ILND? These questions are address through sequential randomisations (InPACT-neoadjuvant and InPACT-pelvis) at two key decision points in the clinical management pathway. Secondary Objectives: In InPACT-neoadjuvant: -Can neoadjuvant therapy prior to surgery (ILND) reduce recurrence rates? -Which is the more active of neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy? -What is the operative/post-operative complication rate following neoadjuvant therapy of both types? -Is neoadjuvant chemoradiotherapy feasible in this setting? In InPACT-pelvis: -What is the rate of additional complications for the combination of PLND and chemoradiotherapy? Exploratory Objectives: Two additional questions will be addressed, in participating patients: -What is the relationship between human paillomavirus (HPV) status and outcome for all groups studied? -What is the impact on quality of life of the (sequential) treatments studied?

Treatments

Therapies

Chemotherapy (NOS); Observational; Radiotherapy; Surgery

Medications

Ifosfamide (); Not Applicable (); Radiotherapy (); Taxol (paclitaxel); cisplatin (); paclitaxel ()

Inclusion Criteria

Written informed consent.

Males age 18 years or older.

Patients being considered for InPACT-neoadjuvant must have either:

Measurable disease as determined by RECIST (version 1.1) criteria or; a single, unilateral lymph node that does not meet RECIST criteria for measurable disease, but that is either palpable or radiologically abnormal, and with histological/cytological evidence of metastatic involvement. This applies only to low disease burden patients who would then be eligible for direct entry into arm A. *Patients with radiological evidence of macroscopic pelvic node involvement are eligible for randomisation in InPACT-neoadjuvant but are not be eligible for entry into InPACT-pelvis.

Histologically-proven squamous cell carcinoma of the penis. Stage: - any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node OR a single radiologically-abnormal inguinal lymph node with no evidence of extra-nodal extension), M0 or; - any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes OR radiologically evident multiple or bilateral inguinal nodes with no evidence of extra-nodal extension), M0 or; - any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0

Measurable disease as determined by RECIST criteria (inPACT neoadjuvant only)

Performance Status ECOG 0, 1 or 2.

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 (see section 5.5.2 for full details) but may be considered for arm A.

Nodal disease burden must be assessable, with all patients stratified into one of three categories (low / intermediate / high disease burden) in accordance with physical examination and Graafland radiological criteria

Glomerular filtration rate (GFR) must be assessed for all patients per protocol guidelines

Inclusion criteria for InPACT-pelvis:

Patient has met eligibility criteria for InPACT-neoadjuvant

Patient has completed ILND within arms A, B or C of InPACT-neoadjuvant

There must be no radiological evidence of residual inguinal disease on cross-sectional imaging performed after therapeutic inguinal lymph node dissection

There must be no radiological evidence of pelvic lymphadenopathy on cross-sectional imaging performed after therapeutic inguinal lymph node dissection.

Patient must be at high risk of relapse following ILND, risk of relapse being assigned on the basis of histological assessment of the ILND specimen. High-risk disease is defined as any patient where ILND reveals either: extranodal extension, bilateral nodal involvement, or 3 or more involved nodes. These patients should be considered at high risk of harbouring occult micrometastatic disease in the ipsilateral pelvic nodes.

Performance Status ECOG 0, 1 or 2.

Patient is fit to receive the randomisation options for which he is being considered.

Willing and able to comply with follow-up schedule.

Written informed consent

Exclusion Criteria

Pure verrucous carcinoma of the penis,

Nonsquamous malignancy of the penis,

Squamous carcinoma of the urethra,

Stage M1,

Previous chemotherapy or chemoradiotherapy outside of the InPACT trial

Any absolute contraindication to chemotherapy if eligible for a chemotherapy/chemoradiotherapy randomisation.

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.

Radiological evidence of macroscopic pelvic lymph node disease on post-ILND cross-sectional imaging

Patients with regionally advanced (N1-3, M0) penile cancer with disease burden that is considered unresectable by the accredited InPACT surgeon* utilising standard inguinal, ilioinguinal lymphadenectomy resection and reconstructive techniques. For example, where procedures would require circumferential resection of the femoral or iliac vessels, or the requirement for hemipelvectomy.

Other criteria apply

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