Trial to Evaluate Progression Free Survival With Primary Retroperitoneal Lymph-node Dissection (pRPLND) Only in Patients With Seminomatous Testicular Germ Cell Tumors With Clinical Stage IIA/B (PRIMETEST)

  • STATUS
    Recruiting
  • End date
    Jun 21, 2021
  • participants needed
    30
  • sponsor
    Heinrich-Heine University, Duesseldorf
Updated on 21 January 2021

Summary

Primary objective:

to evaluate progression-free survival in patients with clinical stage II A/B seminomatous germ cell tumor undergoing primary retroperitoneal lymph node dissection (RPLND) without adjuvant treatment

Secondary objectives:

  • overall survival
  • perioperative complications (Clavien-Dindo score)
  • quality of life (EORTC QLQ C30, EORTC QLQ TC26)
  • long term sequelae
  • rate of retrograde ejaculation

Description

Standard treatment of patients with clinical stage IIA seminoma (isolated retroperitoneal lymph nodes up to 2 cm) is radiotherapy (30Gy) and for clinical stage IIB (isolated retroperitoneal lymph nodes 2-5 cm) is radiotherapy (36Gy, extended iliac field). Alternatively, 3 courses of BEP are equal (1,2,3,4). According to the EAU guidelines 3 cycles of BEP can be substituted for 4 x PE in patients with contraindications for bleomycin. Radiotherapy as well as chemotherapy has several side effects: multiple studies show significant long term toxicity after cisplatin chemotherapy such as cardiotoxicity or nephrotoxicity (5,6,7,8, 9). Patients after radiotherapy show a significant increased rate of secondary malignancies during long term follow-up (relative risk between 1.3 and 1.4) (13, 14).

There are no reliable data on recurrences of patients with seminoma in CS II who have undergone surgery only. After the publication of Warszawski et al in 1997 primary RPLND in seminoma has not been performed on a routine basis (10). However, seminoma metastasis follows the same anatomical principles as non-seminoma and is primarily lymphatic. In clinical stage I high risk seminoma patients the overall recurrence rate without adjuvant therapy is ~ 30%, in CS IIB patients after radiotherapy at around 18%, respectively (11,12). If seminoma stage II patients could achieve a less than 10% recurrence rate after surgery, surveillance as well as a single course adjuvant chemotherapy would again be justified. The overall burden of standard treatment with 3 or 4 courses of chemotherapy could thereby considerably reduced. With a recurrence rate of > 30% (exceeding the upper border of the confidence interval) every third patient would require surgery and chemotherapy and the overall treatment burden would not justify this approach.

Thus, the hypothesis of this trial is currently an overtreatment of patients with low volume metastasis either initially diagnosed or as recurrence with 3 courses BEP chemotherapy as recommended standard treatment in most of these patients. In addition, surgical techniques have evolved and laparoscopic robot-assisted RPLND seems possible in unilateral low stage disease.

In order to clarify the role of primary RPLND in this patient cohort, the progression-free survival has to be explored in a single arm non-randomized trial. Only if the recurrence rate does not exceed the published figures further adjuvant treatment is justified. In a subsequent trial patients may then be selected based on prognostic parameters to receive surveillance after primary RPLND only or to be treated by 1 course of BEP in cases of higher relapse figures. Therefore, this trial may serve as first step to improve the overall treatment burden in patients with clinical stage II disease.

Details
Condition Stage II A/B Seminomatous Germ Cell Tumors, Stage II A/B Seminomatous Germ Cell Tumors
Treatment Primary retroperitoneal lymph-node dissection (pRPLND)
Clinical Study IdentifierNCT02797626
SponsorHeinrich-Heine University, Duesseldorf
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Are you male?
Do you have Stage II A/B Seminomatous Germ Cell Tumors?
Do you have any of these conditions: Do you have Stage II A/B Seminomatous Germ Cell Tumors??
histologically confirmed seminomatous testicular germ cell tumor
inguinal, paraaortic or retroperitoneal lymph nodes classified as local or regional unilateral lymph node metastasis by contrast CT or MRI
maximum dimensions of lymph node metastasis: single mass of max. 5.0 cm in transverse CT diameter multiple metastases in a unilateral field with single max. diameter of 5.0 cm (UICC IIB)
patients with serum tumour marker elevation at the time of CT staging are
eligible if the elevated human chorionic gonadotropin (hCG) directly before
RPLND does not exceed 5 IU/L
patients qualify for this trial with following scenarios
initial diagnosis of UICC clinical stage IIA/IIB disease
recurrence after surveillance for clinical stage I
recurrence after adjuvant treatment of clinical stage I seminoma with 1 x carboplatin AUC7
curative treatment is intended
patients age above 18 years
able to communicate well with the investigator, to understand and comply with the requirements of the study, to understand and sign the written informed consent

Exclusion Criteria

non-seminomatous germ cell tumors
germ cell tumor-related AFP elevation suspicious of non-seminoma
metastatic lymph node mass with greatest dimension >5 cm (CS IIC)
other metastasis (CS III)
patients with prior scrotal or retroperitoneal surgery due to other diseases than germ cell cancer
patient underwent chemotherapy other than adjuvant Carboplatin monotherapy
patient underwent radiotherapy of the retroperitoneum
patient in reduced general condition or with live threatening disease
patient has a psychiatric disease
patient does not have sufficient knowledge of German language
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note