International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study).
Primary ObjectiveS:
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?
Secondary Objectives:
In InPACT-neoadjuvant:
1. Can neoadjuvant therapy prior to surgery (ILND) reduce recurrence rates?
2. Which is the more active of neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy?
3. What is the operative/post-operative complication rate following neoadjuvant therapy of both types?
4. Is neoadjuvant chemoradiotherapy feasible in this setting?
In InPACT pelvis:
1. 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:
1. What is the relationship between human papillomavirus (HPV) status and outcome for all groups studied?
2. What is the impact on quality of life of the (sequential) treatments studied?
IFOSFAMIDE
PACLITAXEL
Chemotherapy multiple agents systemic
- Rutgers Cancer Institute of New Jersey
Inclusion Criteria
1. Written informed consent
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
1. Pure verrucous carcinoma of the penis,
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.