Therapy De-escalation in Seminoma Stage IIA/B

• Status: Active, not recruiting
• Trial end date: 2038-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The main objective of this trial is to test the efficacy and safety of carboplatin chemotherapy and involved node radiotherapy in patients with stage IIA/B seminoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Carboplatin

Criteria

Inclusion Criteria:

• Patient has given written informed consent before registration.

• Histologically confirmed classical seminoma treated with primary inguinal orchidectomy.

• Tumor stage at diagnosis or at relapse after primary active surveillance is pT1-4* cN1-2 cM0 according to UICC TNM 2009 is pT1-4 cN1-2 cM0 according to UICC TNM 2009.

• Multi-slice CT or MRI or FDG-PET-CT of the chest, abdomen and pelvis or a FDG-PET-CT within 4 weeks prior to patient registration, showing stage IIA/B disease. I.v. contrast medium has to be administered.

• Age ≥ 18 years.

• WHO performance status 0-2.

• Adequate hematological values: neutrophils ≥ 1.0 x 109/L, platelets ≥ 100x 109/L.

• Adequate renal function (calculated creatinine clearance ≥ 50 ml/min, according to the formula of Cockcroft-Gault).

• Patient agrees not to father a child during trial treatment and during 12 months thereafter.

• Patient has been proposed sperm conservation.

• Patient compliance and geographic proximity allow proper staging and follow-up for at least 3 years.

Exclusion Criteria:

• Previous or concurrent malignancy within 5 years with the exception of localized non-melanoma skin cancer or stage I seminoma for patients entering the trial with relapse during active surveillance.

• Psychiatric disorder precluding understanding of information on trial-related topics or giving informed consent or interfering with compliance for treatment schedule.

• Mixed histology seminoma.

• Elevated levels of AFP (≥ULN) at any time.

• Any prior abdominal/pelvic radiotherapy (RT).

• Any anti-cancer therapy after primary tumor resection (active surveillance for stage I disease is not considered as a treatment).

• Any treatment in a clinical trial within 30 days of trial entry.

• Any serious underlying medical condition or serious co-morbidity (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial.

• Any contraindication for the trial drug (for example, known hypersensitivity to trial drug or to any other co-component of the trial drug, past or current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major hearing defects).

• Any concomitant drugs contraindicated for use with the trial drug according to the approved product information (for example, nephrotoxic or ototoxic medicines).