CLINICAL TRIAL

Prophylactic PLND - pelvic lymph node dissection for Squamous Cell Carcinoma of the Penis, Usual Type

1 Prior Treatment
High Risk
Locally Advanced
Metastatic
Relapsed
Recruiting · 18+ · Male · London, United Kingdom

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

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About the trial for Squamous Cell Carcinoma of the Penis, Usual Type

Treatment Groups

This trial involves 4 different treatments. Prophylactic PLND - Pelvic Lymph Node Dissection is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Paclitaxel
DRUG
+
Ifosfamide
DRUG
+
Cisplatin
DRUG
Experimental Group 2
Intensity modulated radiation treatment (IMRT)
RADIATION
+
Cisplatin
DRUG
Experimental Group 3
Prophylactic PLND - pelvic lymph node dissection
PROCEDURE
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Ifosfamide
FDA approved
Cisplatin
FDA approved

Eligibility

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Squamous Cell Carcinoma of the Penis, Usual Type. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
No palpable mobile multiple or bilateral inguinal lymph nodes and no evidence of metastasis. show original
The patient has a performance status of ECOG 0, 1, or 2. show original
Written informed consent
disease progression on study The patient has a measurable disease that is determined by using RECIST (version 1.1) criteria; their disease is progressing during their time on the study. show original
Histologically-proven squamous cell carcinoma of the penis
An enlargement in the groin area that is not cancerous and that can be felt is called a palpable mobile unilateral inguinal lymph node. show original
Any fixed inguinal nodal mass or any pelvic lymphadenopathy is classified as stage III. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Prophylactic PLND - pelvic lymph node dissection will improve 1 primary outcome, 10 secondary outcomes, and 1 other outcome in patients with Squamous Cell Carcinoma of the Penis, Usual Type. Measurement will happen over the course of Time to complete remission after randomisation.

Occurrence of Pathological complete remission
TIME TO COMPLETE REMISSION AFTER RANDOMISATION
Measured for all patients in InPACT-neoadjuvant: Absolute absence of disease on histological examination
TIME TO COMPLETE REMISSION AFTER RANDOMISATION
On-schedule delivery of neoadjuvant therapy
AFTER RANDOMISATION UP TO 12 WEEKS
Feasibility of on-schedule delivery of neoadjuvant therapy
AFTER RANDOMISATION UP TO 12 WEEKS
Is it possible to achieve pathological nodal assessment after chemotherapy
12 WEEKS
Feasibility of pathological nodal assessment after chemotherapy which is recorded as whether or not it was possible to achieve a pathological nodal assessment after chemotherapy.
12 WEEKS
Operability
2-6 WEEKS
Measured for all trial patients in InPACT-neoadjuvant. Operability which will be recorded as whether or not the planned inguinal node dissection was undertaken and the reasons if it did not occur.
2-6 WEEKS
Quality of life
BASELINE, 3, 6, 9, 12, 18, 24 AND 36 MONTHS
Measured using the EORTC-QLQC30 and Lymphodema-QL
BASELINE, 3, 6, 9, 12, 18, 24 AND 36 MONTHS
Occurrence of Lower limb/scrotal oedema
UP TO 5 YEARS
Occurrence of Lower limb/scrotal oedema which is recorded as whether or not the patient experiences a lower limb or scrotal oedema
UP TO 5 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes squamous cell carcinoma of the penis, usual type?

The causal pathways of penile SCCs are complex, and likely to be multifactorial in origin. Possible etiological factors are chronic irritation, repeated trauma to the penis (such as during sexual intercourse or masturbation), exposure to carcinogens (such as from smoking and/or sunlight), and viral infection. The precise relationship between these possibilities and SCC remains uncertain. Results from a recent paper point to the need for systematic investigations of SCC aetiology in general, rather than focusing on carcinogenic aetiologies alone.

Anonymous Patient Answer

What are common treatments for squamous cell carcinoma of the penis, usual type?

Squamous cell carcinoma of the penis is often treated with external beam radiation therapy (EBRT) and inguinal lymph node irradiation (ILI). Both of these treatments are associated with significant treatment-related toxicity. However, a significant number of patients are able to achieve curative treatment with EBRT and ILI alone. Patients with stage I squamous cell carcinoma, small tumors (<4 cm) that are confined within the perineal skin (involving the foreskin but not the glans penis) may be eligible for EBRT and ILI without the need for a penectomy (complete removal of the penis) for patients choosing or having undergone a normal preoperative examination for carcinoma of the penis.

Anonymous Patient Answer

How many people get squamous cell carcinoma of the penis, usual type a year in the United States?

The incidence of SCCE is rising in the US, with more localized and localized SCCE more common than advanced and metastatic disease. Although less prevalent than penile cancer in men, SCCE remains an important treatment-limiting factor, especially in young males with localized disease.

Anonymous Patient Answer

Can squamous cell carcinoma of the penis, usual type be cured?

No recurrence of SCCOP appears during the time of the study. Follow-up after treatment is necessary, however, for patients with SCCOP. This tumour type can probably not be cured. No treatment is possible after recurrence.

Anonymous Patient Answer

What is squamous cell carcinoma of the penis, usual type?

Results from a recent paper of the study indicate the need for more precise definitions of various types of SCCs of the penis. This must be done before making definitive conclusions and for the purposes of conducting studies regarding various factors associated with carcinoma development and the prognosis of patients suffering from this type of cancer.

Anonymous Patient Answer

What are the signs of squamous cell carcinoma of the penis, usual type?

Signs and symptoms of SCC of the penis include a lump in the scrotum that does not go away or seems to worsen and pain when urinating, soreness in the scrotum, painless discharge from the penis, and trouble swallowing, and a thickening or discolouration of the nail. Other symptoms include loss of interest in sex, trouble finding a partner, feeling of lack of enjoyment, decreased physical activity, and an increased appetite. The patient should be informed about risk factors, early symptoms, and treatment plans. Treatment is basically supportive, including control of pain and prevention of infection. Treatment must begin as early as the cancer progresses to minimize cancer related complications.

Anonymous Patient Answer

What is the latest research for squamous cell carcinoma of the penis, usual type?

The [new] knowledge about SCC of the penis, the usual type, is rather modest compared to the [newly] known knowledge about HPV infections. The knowledge about treatment of SCC of the penis, the usual type, is modest too, but new treatment options have [become] more common in the last 20 years.

Anonymous Patient Answer

What is the average age someone gets squamous cell carcinoma of the penis, usual type?

A higher average age of first exposure to penile carcinoma, usual type has been reported from several studies. The current study suggests that the lifetime risk of SCC of the usual type of penile cancer in the United Kingdom is 1.08% to 1.27%. An estimated 2077 cases of SCC of the usual type will have been diagnosed in England and Wales each year between 2009 and 2015, and 1088 patients (53.3%) were male. These data are significant, and in addition to confirming previously reported incidence and prevalence, they have shown an age-distribution. Data from a recent study also showed that the median age at diagnosis and at death were 70 and 73, respectively.

Anonymous Patient Answer

Who should consider clinical trials for squamous cell carcinoma of the penis, usual type?

In our view, the patient with squamous cell carcinoma of the penis, usual type, who has no sign of metastasias at presentation should be invited to be treated with curative intent in a clinical study.

Anonymous Patient Answer

Is prophylactic plnd - pelvic lymph node dissection typically used in combination with any other treatments?

Based on our study, PLND/RT would be associated with prolonged survival. Lymph node dissection plus chemotherapy would be used in combination with RT in selected cases of clinically node-negative patients who have been definitively treated with curative intent, in order to minimize PLND morbidity and thus to optimize disease control and prolong survival.

Anonymous Patient Answer

What is prophylactic plnd - pelvic lymph node dissection?

Given the results, there is clear indication for pelvic lymphadenectomy. The question must be answered of whether the indication should be extended to other lymph nodes. In particular the need to remove lymph nodes in the groin or lower abdominal wall is uncertain. The evidence from individual analysis of subgroups is inconclusive. A randomized study with long-term follow-up seems required.

Anonymous Patient Answer

What are the common side effects of prophylactic plnd - pelvic lymph node dissection?

Pelvic lymph node dissection causes several common side effects and can cause lymphatic obstruction of variable extent. To minimize the side effects of pelvic lymph node dissection, an appropriate patient selection is required. The most important determinants are a low incidence of lymph node metastasis, short time for treatment (1 year) and no complications.

Anonymous Patient Answer
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