Blood and Lymph Conditions

All Conditions

Neoplasms

Rare Diseases

Lymphadenopathy

Seminoma

Germinoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Lymphatic Diseases

Testicular Seminoma

Central Nervous System Germinoma

Laboratory Biomarker Analysis

Retroperitoneal Lymph Node Dissection

Siamak Daneshmand

This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in the body behind the intestines that is typically the first place that seminoma spreads. RPLND is a surgery that removes lymph nodes in this area to treat testicular seminoma and may experience fewer long-term toxicities, such as a second cancer, cardiovascular disease, metabolic syndrome (pre-diabetes), or lung disease.

PRIMARY OBJECTIVES:

I. Assess the recurrence free survival (RFS) at 2 years after RPLND when RPLND is used as a first line treatment for patients with testicular seminoma and low volume (=\< 2cm) retroperitoneal disease.

SECONDARY OBJECTIVES:

I. Estimate the percent of patients, after treatment with RPLND, who can avoid external beam radiotherapy (XRT) or systemic chemotherapy (CTX) for seminoma.

II. Assess the complications associated with primary RPLND for seminoma.

OUTLINE:

Patients undergo RPLND.

After completion of study treatment, patients are followed up at 1 month, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

Surgery in Early Metastatic Seminoma (SEMS): Phase II Trial of Retroperitoneal Lymph Node Dissection as First-Line Treatment for Testicular Seminoma With Isolated Retroperitoneal Disease (1-3cm)

Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method. The recurrence location (pelvic, retroperitoneal, distant) will be calculated as a percentage of total recurrences to describe the clinical pattern of disease after relapse.

The rate of short and long term complications will be calculated.

Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method.

National Cancer Institute (NCI)

University of Southern California

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Carcinoma

Adenocarcinoma

Ovarian Neoplasms

Gastrointestinal Stromal Tumors

Neuroendocrine Tumors

Glioma

Aggression

Carcinosarcoma

Mixed Tumor, Mullerian

Adenocarcinoma, Clear Cell

Fibromatosis, Aggressive

Carcinoma, Small Cell

Adenocarcinoma, Mucinous

Cystadenocarcinoma

Sex Cord-Gonadal Stromal Tumors

Fibroma

Neoplasms, Glandular and Epithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Nerve Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Sarcoma

Neoplasms, Cystic, Mucinous, and Serous

Neoplasms, Fibrous Tissue

Ovarian Cancer

Neuroendocrine Tumor

Germ Cells Tumors

Adenocarcinoma of the Appendix

Malignant Mixed Mullerian Tumor

Desmoid Tumor

Ovarian Germ Cell Tumor

Nonseminomatous Germ Cell Tumor

Neuroepithelioma

Soft Tissue Sarcoma

On-site surveillance by a hospital physician

Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Oncological Follow-up

Laurence ROTSAERT

Fanny BEN OUNE

Guillaume BONNET

Mathieu BOONE, MD

François GERNIER

Nicolas PENEL, MD

PENEL Nicolas, MD, PhD

This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

The primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms.

The secondary objectives are to compare between the two arms :

* Long-term compliance (5-year follow-up)
* Use of care
* Oncological events and their management
* Supportive care needs

The exploratory objectives are to :

* Evaluate the costs in terms of medical transportation
* Evaluate and compare patients' satisfaction and psychological well-being (in terms of anxiety/depression)
* Evaluate the homogeneity of the impact of the intervention according to covariates (gender, tumor pathology, occupational status, and center)
* Evaluate the reasons for recruitment failures

Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring

Medical transport includes light medical vehicles and ambulances

Salary mass mobilized from a hospital perspective in both arms

Patients will answer a satisfaction survey (French Version of the Princess Margaret Hospital Satisfaction With Doctor) at different points of the study depending on their pathology

Patient reported outcomes will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire at different points of the study depending on their pathology.

The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression:

A score equal to or less than 7 indicates no symptoms, A score of 8 - 10 indicates a questionable symptoms, A score of 11 and above confirms of the presence of anxiety and/or depression symptoms.

In each investigating site, a screening log will be completed to find out the reasons for recruitment failures

Compliance is defined by completion of all scheduled examinations (telephone contact, biological, clinical examination and imaging examination) with a margin of + or - 30 days from the scheduled date

Rate of patients lost to follow-up or quitting the surveillance program

* number of physical consultations at the investigator site
* number of emergency room visits for oncological reasons
* number of extra-hospital consultations for oncological reasons

Occurence and type of oncological event : relapse/progression.

The management of oncological events will be evaluated according to three criteria :

* completion of an oncological surgery
* implementation of a treatment by radiotherapy
* implementation of a systemic therapy such as chemotherapy

Time from randomization to first oncological event (progression/relapse) or death from any cause.

Time from randomization to death from any cause

Support care needs include :

* algology consultation
* nutrition/diet consultation
* psycho-oncology consultation
* social worker consultation
* job retention consultation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma	NCT02537548	Lymphadenopathy Stage I Testicu... Stage II Testic...	Laboratory Biom... Retroperitoneal...	16 Years -	University of Southern California
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring	NCT05500391	Stage I Testicu... Stage I Testicu... Gastrointestina... Ovarian Germ Ce... Adenocarcinoma,... Borderline Ovar... Sex Cord-Stroma... Mucinous Adenoc... Carcinoma, Smal... Carcinosarcoma,... Serous Tumor of... Glioma Neuroendocrine ... Aggressive Fibr...	Oncological Fol...	18 Years -	Centre Oscar Lambret
Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma	NCT02537548	Lymphadenopathy Stage I Testicu... Stage II Testic...	Laboratory Biom... Retroperitoneal...	16 Years -	University of Southern California

Spots Global Cancer Trial Database for stage i testicular seminoma