Reduced intensity radio-chemotherapy for stage IIA/B seminoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Swiss Group for Clinical Cancer Research

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

20 Aug 2020 → ongoing

Decision date (initial)

2024-08-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

SSKK · Roche · SAKK · Rising Tide Foundation for Clinical Cancer Research · Krebsforschung Schweiz · Krebsliga beider Basel · Hedy Glor Meyer Stiftung

External identifiers

EU CT number

2023-509663-24-00

EudraCT number

2019-000514-11

WHO UTN

U1111-1303-1967

ClinicalTrials.gov

NCT03937843

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To investigate efficacy of a stage-adapted treatment regimen in stage IIA/B seminoma based on the preliminary experience gained in SAKK 01/10

Secondary objectives 1

1. To investigate Response Rate, PFS, TTP, OS Seminoma-specific survival, time to distant metastasis, time to next treatment, localization of progression, method of detection of progression, AE, late AE, incidence of second tumors, development of metabolic syndrome, development of hypogonadism of a stage-adapted treatment regimen in stage IIA/B seminoma.

Conditions and MedDRA coding

Stage IIA/B seminoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
2. Histologically confirmed classical seminoma treated with primary inguinal orchidectomy or partial orchidectomy
3. Patients with a seminoma stage IIA or IIB, either newly diagnosed or recurrent after primary active surveillance, adjuvant carboplatin or radiotherapy for stage I disease. The tumor stage is pT1-4 cN1-2 cM0 according to UICC TNM 8th edition 2016. Patients with a recurrent seminoma stage IIA or IIB are only eligible in case of progression under active surveillance or recurrence after adjuvant carboplatin or radiotherapy for stage I disease
4. Stage IIA, in patients with equivocal lymph node enlargement, needs to be confirmed with a repeated CT/MRI scan of the abdomen (suggested timeframe: 4 weeks after the previous scan) in order to rule out false positive lymph node enlargement. Patients with a prior malignancy treated with curative intention are eligible if all treatment of that malignancy was completed at least 5 years before registration and the patient has no evidence of disease at registration. Less than 5 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence. Patients with a germ cell neoplasia in situ (GCNIS) or contralateral localized treated seminoma are eligible.
5. Diagnostic CT or MRI or FDG-PET-CT of the chest, abdomen and pelvis within 28 days prior to registration, showing stage IIA/B disease. I.v. contrast medium has to be administered
6. Age ≥ 18 years
7. WHO performance status 0-2
8. Baseline PRO questionnaires have been completed
9. Adequate bone marrow function: neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 100x 10^9/L
10. Adequate renal function: creatinine clearance ≥ 60 ml/min calculated according to the CKD-EPI formula
11. Patient agrees to use highly effective contraception and not to donate sperm or to father a child during trial treatment and during 12 months thereafter. Patient has been proposed sperm conservation

Exclusion criteria 11

1. Any other histological component than seminoma
2. Elevated levels of Alpha-1-Fetoprotein AFP (≥ 2x ULN)
3. Involved nodes (metastatic) in previously irradiated localizations in the abdomen or pelvis
4. Any anti-cancer therapy after primary tumor resection in patients presenting with primary stage IIA/B seminoma
5. Any serious underlying medical condition (i.e. current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major hearing defects) or serious co-morbidity which could impair the ability of the patient to participate in the trial (according to investigator's judgment)
6. Any treatment in a clinical trial within 28 days prior to registration
7. Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or contraindicated for use with radiotherapy
8. Known hypersensitivity to trial drugs or to any component of the trial drugs
9. Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications
10. Additional German specific exclusion criterion - not to be considered for Swiss patients: Patient who is dependent on the sponsor or the investigators according to ICH/GCP E6(R2) guideline
11. Additional German specific exclusion criterion - not to be considered for Swiss patients: Patient who has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities according to § 40a (2) AMG

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression free survival (PFS) at 3 years

Secondary endpoints 9

1. Response rate (RR)
2. Progression free survival (PFS)
3. Time to progression (TTP)
4. Overall Survival (OS)
5. Seminoma-specific survival
6. Time to distant metastasis
7. Time to next treatment
8. Localization of progression
9. Method of detection of progression

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Swiss Group for Clinical Cancer Research

Sponsor organisation

Swiss Group for Clinical Cancer Research

Address

Effingerstrasse 33

City

Bern

Postcode

3008

Country

Switzerland

Scientific contact point

Organisation

Swiss Group for Clinical Cancer Research

Contact name

Competence Center of SAKK

Public contact point

Organisation

Swiss Group for Clinical Cancer Research

Contact name

Competence Center of SAKK

Third parties 2

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications