Retroperitoneal Lymph Node Dissection for Testicular Seminoma

Recruiting at 13 trial locations

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Second malignancy, Chemotherapy, Radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

55 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking investigational agents or have uncontrolled illnesses, you may not be eligible to participate.

What data supports the effectiveness of the treatment Retroperitoneal Lymph Node Dissection for Testicular Seminoma?

Retroperitoneal lymph node dissection is shown to be effective in managing testicular cancer by providing high cure rates and reducing long-term side effects compared to radiation or chemotherapy. Advances in surgical techniques have minimized complications, making it a viable option for treating testicular seminoma. ^{1 2 3 4 5}

Is retroperitoneal lymph node dissection generally safe for humans?

Retroperitoneal lymph node dissection (RPLND) is generally considered safe with minimal long-term side effects, especially when nerve-sparing techniques are used. However, patients who undergo RPLND after chemotherapy may face a higher risk of complications during and after the surgery. ^{1 6 7 8 9}

How is retroperitoneal lymph node dissection different from other treatments for testicular seminoma?

Retroperitoneal lymph node dissection is a surgical treatment that may offer an alternative to radiation or chemotherapy for testicular seminoma, potentially reducing long-term side effects while maintaining high cure rates. Unlike traditional open surgery, the laparoscopic approach can shorten hospital stays and speed up recovery, although it is technically demanding and may have a higher risk of complications. ^{1 2 3 5 10}

Research Team

Siamak Daneshmand

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for patients with stage I-IIa testicular seminoma who've had an orchiectomy and show signs of cancer spread to lymph nodes in the retroperitoneum. Eligible participants should not have received prior chemotherapy or radiotherapy, must be within three years of initial diagnosis, and have good overall health as indicated by ECOG status.

Inclusion Criteria

If I had a biopsy, it showed pure seminoma.

My recent chest scans show no signs of cancer spread.

I can carry out all my self-care but cannot do heavy physical work.

Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

I have had chemotherapy or radiotherapy in the past.

Patients receiving any other investigational agent(s)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo retroperitoneal lymph node dissection (RPLND) as first-line treatment for testicular seminoma

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recurrence and complications after RPLND

5 years

1 visit at 1 month, every 4 months for 1 year, every 6 months for 2 years, then annually

Treatment Details

Interventions

• Retroperitoneal Lymph Node Dissection

Trial Overview The study is testing the effectiveness of Retroperitoneal Lymph Node Dissection (RPLND) surgery in treating testicular seminoma that has potentially spread to abdominal lymph nodes. The goal is to see if this procedure can reduce long-term health issues like second cancers or heart disease.

Participant Groups

Group I: Treatment (RPLND) Experimental Treatment 2 Interventions

Patients undergo RPLND.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Retroperitoneal Lymph Node Dissection as an Alternative Treatment Strategy for Low Volume, Clinical Stage II Testicular Seminoma: A Survey of Patients and Providers. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic retroperitoneal lymph node dissection in stage A nonseminomatous testis cancer. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

What is the role of enlarged lymph node resection alone in patients with nonseminomatous germ cell tumor who had stage II or III disease? [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Role of Retroperitoneal Lymph Node Dissection in the Management of Testicular Cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic retroperitoneal lymph node dissection. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Complications of retroperitoneal lymph node dissection. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Indications for Surgery in Disseminated Seminoma. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Retroperitoneal Lymph Node Dissection as First-Line Treatment of Node-Positive Seminoma. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Primary robotic RLPND for nonseminomatous germ cell testicular cancer: a two-center analysis of intermediate oncologic and safety outcomes. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic approach to retroperitoneal lymph node dissection. [2004]