Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Penile Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Ifosfamide

Isophosphamide mustard

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

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.

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

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.

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:

1. Any macroscopic tumour or pathological lymph nodes
2. Electively to external iliac nodes in patient with high disease burden

Patients who have had neoadjuvant chemoradiotherapy will have prophylactic PLND alone.

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

Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.

ILND - Inguinal Lymph Node Dissection

Dose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)

Treatment with very high energy X-rays (radiotherapy).

Intensity modulated radiation treatment (IMRT)

Surgery to remove the lymph nodes deeper in the pelvis, further away from where the cancer first appeared, that are at high risk of harbouring cancer.

Prophylactic PLND - pelvic lymph node dissection

UK - InPACT Senior Trial Manager

US/Canada - InPACT DA for EA8134

Anne Schuckman

Sia Daneshmand

Phil Spiess

Viraj Master

Lance Pagliaro

Stephen Boorjian /Jeffrey Karnes (karnes.r@mayo.edu)

Curtis Pettaway

Dr James Barber

Dr Christopher Kent

Mr Nick Watkin

Mr Vivekanandan Kumar

Steve Nicholson

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions.

InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments:

A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).

After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either:

P. prophylactic PLND Q. no prophylactic PLND

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

In addition to the outcome measures, the acceptability of both randomisations will be monitored based on the proportion of eligible patients approached for randomisation, the proportion of approached patients consenting to randomisation and the proportion of randomised patients receiving their allocated treatment. This will provide ongoing information regarding the feasibility of the trial successfully completing to target.

The primary outcome measure that will be measured for all trial patients is survival time. This is defined in whole days as the time from the date of randomisation to the date of death from any cause; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up.

Disease-specific survival time which is defined in whole days as the time from the date of randomisation to the date of death specifically from disease; for those who have not been reported as dead at the time of analysis, the survival time will be censored at the date of last follow-up and for those whose death is reported as non-disease specific then the survival time will be censored at date of death.

Disease-free survival time (DFST) which is defined in whole days as the time from date of randomisation to the date of either locoregional recurrence, distant metastasis or death from disease, whichever occurs first; for those who have not been reported as experiencing any of these events, the DFST will be censored at the date last known to be alive and free of disease or date of non-disease-specific death. A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin rather than date of randomisation.

Subsidiary outcome measures will be

* locoregional recurrence free survival time (LRFST).
* distant metastases free survival time (DMFST).
* A supplementary exploratory outcome measure will also be calculated taking date of penectomy as the origin for all these outcome measures rather than date of randomisation.

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.

Measured using the EORTC-QLQC30 and Lymphodema-QL

Measured for all patients in InPACT-neoadjuvant:

Absolute absence of disease on histological examination

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.

Occurrence of Lower limb/scrotal oedema which is recorded as whether or not the patient experiences a lower limb or scrotal oedema

Feasibility of on-schedule delivery of neoadjuvant therapy

National Cancer Institute (NCI)

ECOG-ACRIN Cancer Research Group

Institute of Cancer Research, United Kingdom

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Digestive System Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Uterine Cervical Neoplasms

Vulvar Neoplasms

Virus Diseases

Papilloma

Anus Neoplasms

Warts

Condylomata Acuminata

Head and Neck Neoplasms

Penile Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Vulvar Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Communicable Diseases

Papillomavirus Infections

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Genital Neoplasms, Male

Genital Diseases, Male

Penile Diseases

Male Urogenital Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Vulvar Cancer

Vaccines

The receiver is an immigrant mother born in Eritrea, Somalia, Syria, Afghanistan, Iran or Iraq.

The receiver is a mother born in Sweden whose education does not exceed 3 years of high school.

The receiver is a mother born in Sweden whose education is at least 3 years of high school but no more than high school diploma.

The receiver is a mother born in Sweden whose education is at least some college (undergrad) but does not exceed an undergraduate degree

The receiver is a mother born in Sweden whose education is an undergraduate degree plus at least some graduate education

A4 information sheet on HPV vaccine containing a reminder of the upcoming HPV vaccination, and information on: (i) its safety and efficacy in preventing a number of cancerous diseases, affecting both women and men; (ii) what is HPV and how contagion happens; (iii) the consequences of cervical cancer for women, in terms of invasive medical treatments and temporary or permanent loss of fertility. The information is framed in non-scientific, non-statistical terms and is emotionally charged: the consequences of cervical cancers are portrayed by testimonies of cancer survivors from Sweden.

Information T1

A4 information sheet on HPV vaccine containing a reminder of the upcoming HPV vaccination, and information on: (i) its safety and efficacy in preventing a number of cancerous diseases, affecting both women and men; (ii) what is HPV and how contagion happens; (iii) the consequences of cervical cancer for women, in terms of invasive medical treatments and temporary or permanent loss of fertility. The information is framed in scientific terms and incidence and mortality statistics are reported. The information is not emotionally charged but rather aseptic.

Information T2

A4 information sheet containing a reminder of the upcoming HPV vaccination, and information on the history and characteristics of the Swedish national vaccination program.

Information C

Lisen A. Dahlström, Ph.D.

Counteracting misinformation on childhood vaccines remains a priority for public health in industrialized countries. Previous research showed that misinformation-induced vaccine hesitancy particularly concerns very highly or very lowly educated parents, and, especially in Europe, specific groups of immigrants. Misinformation framing directly targets specific sub-population of parents by exploiting different cognitive biases, and specific concerns based on cultural norms: this project aims at testing the effectiveness of similar framing techniques applied to positive information on the HPV vaccine by conducting a Randomized Controlled Trial in Stockholm, Sweden. It randomizes emotionally and scientifically/statistically framed information addressing the specific concerns reported by previous literature.

In Europe, non-European immigrants display lower vaccination take-up than natives, a higher prevalence of STDs, and lower usage of publicly-funded treatments. Therefore, migrants (and especially women) face worse preventable health issues. Qualitative research suggests that migrants' lower take-up might be due to culturally founded concerns, which are then exploited and targeted by anti-vax information. These are adverse effects on fertility and, in the case of the HPV vaccine, which is administered at a very young age to prevent a sexually-transmissible infection, on reputational concerns related to incentivizing pre-marital sexual activity. Existing literature also investigates parental education as an alternative explanation to vaccines' mistrust, finding mixed evidence which suggests a non-linear relationship between education level and willingness to vaccinate children. In particular, qualitative research highlights that targeted misinformation addresses emotionally charged contents to lowly educated parents, and pseudo-scientific content to highly educated parents.

In this study, 7500 mothers of children (girls and boys) who are due to be offered the HPV vaccine in fall 2021 within the Swedish national vaccination program are randomly sampled. Mothers are stratified according to immigration status, and are sampled from the entire relevant population through Swedish population registers. There are 5 strata: (i) Mothers were born in Iran, Iraq, Afghanistan, Somalia, Eritrea (irrespective of education) (N=2500); (ii) Mothers born in Sweden and have attended at most 3 years of high school (N=1600); (iii) Mothers born in Sweden and have attended more than 3 years of high school and have not attended any university (N=1400); (iv) Mothers born in Sweden and have achieved at most undergraduate education (N=1000); (v) Mothers born in Sweden with graduate education after obtaining an undergraduate degree (N=1000). Sample sizes are chosen with the expectation of having 500 actual participants per stratum, based on participation rate estimates from the implementer (Statistics Sweden, SCB).

Within each stratum, the investigators randomize 3 types of information sheets on the HPV vaccine: emotionally-framed (T1), scientifically and statistically framed (T2) and uninformative placebo (C). Along the information sheet, all mothers receive a first survey covering their beliefs on vaccines (henceforth defined "baseline survey" for simplicity, despite being administered along the treatment), which does not vary across treatment arms. The information sheet and the baseline survey invitation are sent by ordinary post in June 2021 to the mother's address, and the survey can be compiled both on paper and online. In July and August, mothers who have still not compiled the baseline survey will receive 3 reminders: each reminders contains the information sheet, which depending on the specific reminder can be printed or accessible in digital format when accessing the online survey. Between September and October, all mothers will have to decide whether to authorize HPV vaccination for their child, which takes places directly at school and free of charge. In November, mothers who have responded to the baseline survey receive an invitation to an endline survey. All information sheets and surveys are available in Swedish, English, Arabic and Farsi. Informed consent is obtained in the baseline survey. For mothers who choose to participate, investigators will obtain, from population registers, background variables concerning the mother herself, the other parent and the child who is due to immunization. These cover specific information on parents' education, income, wealth and occupation, marital status, number of total children, gender of the child due to HPV vaccination, and if she/he received the previous vaccine in the national program's schedule (3 to 4 years before our intervention), order of the child among siblings.

We are randomly sampling mothers of children who are due for HPV immunization in fall 2021 according to the Swedish national vaccination program. Only for children who do not have a female guardian we invite a male guardian to participate (N=73).

Education, Immigration and HPV Vaccination: an Informational Randomized Trial

Utbildningsnivå, Invandringsstatus Och Viljan Att Vaccinera Mot HPV Som Funktion av Informationsformulering: En Randomiserad Studie

Investigators will assess if there are significant differences in the frequency of parents who decide to vaccinate across treatment arms, within each stratum

The investigators will examine whether across treatment groups, within strata, parents show different degrees of agreement with false statements concerning the risks of HPV, after reading the information sheet corresponding to their treatment arm

The investigators will examine whether across treatment groups, within strata, parents show different degrees of agreement with false statements concerning the risks of HPV, after they have already decided whether to vaccinate their child and vaccination has taken place

Investigators will assess, within strata and across treatment arms, whether individual treatments affected common beliefs about the benefits and risks of the HPV vaccine, which are observed more often among specific group of parents and which are believed to drive vaccine hesitancy. These beliefs are directly addressed by the informational intervention. They concern the perceived benefits/risks of the HPV vaccine relative to fertility, cancer and other illnesses' incidence and sexual behavior, such as whether the HPV vaccine incentivizes sexual activity of teenagers, or if it changes the probability that the teenager develops a cancer in the future. In the second case, the vaccine actually decreases that probability, but anti-vax information would postulate the opposite: we test whether across treatment arms there are significant differences in the degree of agreement with statements on these beliefs.

Investigators will assess whether the treatment effect has a significant interaction with the following variables which, unless specified otherwise, are extracted from population registers based on administrative data: -Field of education (medical vs non-medical and quantitative vs non-quantitative) -Presence of a medical doctor in the close network of the parent\[from baseline survey\] and other parent being a health worker -Self-declared percentage of the information sheet they actually read \[from baseline survey\] -Preferred source of information on vaccines \[from baseline survey\] - Household and mother's wealth - Previous knowledge of HPV and HPV vaccine \[from baseline survey\] -Marital status of the mother - Child being the firstborn - Child being female

Investigators will test, within each stratum, whether the self-reported intention to vaccinate \[post-treatment baseline survey\] and the objective measure of vaccination \[from vaccination registers\] are statistically different. While the objective vaccination indicator is by definition a binary variable, the subjective indicator is initially reported on a Likert scale by subjects, and then reduced to a binary indicator by investigators for immediate comparison.

Merck Sharp & Dohme LLC

Karolinska Institutet

Affiliated to Research

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Mouth Neoplasms

Oropharyngeal Neoplasms

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Oral Cancer

20 ml of blood sample will be made before the beginning of all treatment. This blood sample will be sent to the CERBA Laboratory for analysis.

In parallel, a standard anatomopathological and virological analysis will be carried out from a biopsy or from a tumor sample by the Tumor Biology Unit at Lorraine Institute of Oncology

The results of both analyzes will be compared blindly.

CaptHPV method

SASTRE-GARAU Xavier, MD

The current project is based on the assumption that a diagnosis of human papillomavirus associated Infiltrating Carcinomas can be made from a blood sample for patient with Cervical Cancer, Vulvar Cancer, Anal Cancer, Oropharynx Cancer, Oral Cavity Cancer or Penis Cancer at any stage of the disease and including surgical treatment for the small tumors.

CaptHPV : Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas

Monocentric Study of Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas From a Biological Specimen.

The diagnostic value of the serum marker provided by the method CaptHPV will be assessed in sensitivity and specificity to results of histological and virological analyzes of a sample tumor.

Institut de Cancérologie de Lorraine

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Diabetes Mellitus

Breast Neoplasms

Pancreatic Neoplasms

Stomach Neoplasms

Carcinoma, Renal Cell

Lung Neoplasms

Epilepsy

Urinary Bladder Neoplasms

Pain

Pancreatitis

Pancreatitis, Chronic

Kidney Neoplasms

Nervous System Neoplasms

Pelvic Neoplasms

Neuralgia

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Adenocarcinoma

Kidney Diseases

Chronic Disease

Disease Attributes

Stomach Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Pancreatic Cancer

Renal Cell Carcinoma

Chronic Graft Versus Host Disease

Stomach Cancer

Clear Cell Renal Cell Carcinoma

Analgesics

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Gabapentin

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

The study cohort from which cases and controls are drawn is all subjects in the United Kingdom (UK) General Practice Research Database (GPRD) 1993-2008. Each member of the UK population is registered with a General Practice, which centralizes the medical information not only from the general practitioners themselves but also from specialist referrals and hospital attendances. Over 487 General Practices contribute data to the GPRD. Entry into the study cohort begins Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of registration if later than Jan 1, 1993. Subjects are excluded from the GPRD cohort if they have a cancer diagnosis or a history of cancer prior to the cohort entry date.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)	NCT02305654	Squamous Cell C...	ILND - Inguinal... Paclitaxel Ifosfamide Cisplatin Intensity modul... Prophylactic PL...	18 Years -	Institute of Cancer Research, United Kingdom
Education, Immigration and HPV Vaccination: an Informational Randomized Trial	NCT04905030	Cervical Cancer Vulvar Cancer Anus Cancer Penis Cancer Mouse Papilloma Head Cancer Genital Wart Neck Cancer	Information T1 Information T2 Information C	-	Karolinska Institutet
CaptHPV : Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas	NCT02981862	Cervical Cancer Vulvar Cancer Anal Cancer Oropharynx Canc... Oral Cavity Can... Penis Cancer	CaptHPV method	18 Years -	Institut de Cancérologie de Lorraine
Cancer in Patients With Gabapentin (GPRD)	NCT01236053	Pain, Neuropath... Epilepsy Renal Pelvis Ca... Pancreatic Canc... Breast Cancer Nervous System ... Chronic Pancrea... Stomach Cancer Renal Cell Carc... Diabetes Bladder Cancer Bone and Joint ... Penis Cancer Anal Cancer Cancer Renal Cancer	Gabapentin pres...	-	GlaxoSmithKline
CaptHPV : Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas	NCT02981862	Cervical Cancer Vulvar Cancer Anal Cancer Oropharynx Canc... Oral Cavity Can... Penis Cancer	CaptHPV method	18 Years -	Institut de Cancérologie de Lorraine

Spots Global Cancer Trial Database for penis cancer

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