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Clinical Trial 19319

Cancer Type:
Interventions:Ifosfamide; Not Applicable; Taxol (paclitaxel); cisplatin; paclitaxel

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Philippe Spiess

Call 813-745-6100
or 1-800-679-0775
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?

Inclusion Criteria

  • Written informed consent.
  • Males age 18 years or older.
  • Measurable disease as determined by RECIST (version 1.1) criteria.
  • Histologically-proven squamous cell carcinoma of the penis, Stage: a.) any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or; b.) any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or; c.) any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0.
  • Performance Status ECOG 0, 1 or 2.

  • Exclusion Criteria

  • Pure verrucous carcinoma of the penis,
  • Nonsquamous malignancy of the penis,
  • Squamous carcinoma of the urethra,
  • Stage M1,
  • Previous chemotherapy or chemoradiotherapy,
  • 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.