2023-509663-24-00招募中2 期
SAKK 01/18: Reduced intensity radio-chemotherapy for Stage IIA/B seminoma. A multicenter, open label phase II trial with two cohorts
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 95
- 试验地点
- 9
- 主要终点
- Progression free survival (PFS) at 3 years
研究概览
简要总结
To investigate efficacy of a stage-adapted treatment regimen in stage IIA/B seminoma based on the preliminary experience gained in SAKK 01/10
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
- •Adequate renal function: creatinine clearance ≥ 60 ml/min calculated according to the CKD-EPI formula
- •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
- •Histologically confirmed classical seminoma treated with primary inguinal orchidectomy or partial orchidectomy
- •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
- •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
- •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.
- •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
- •Age ≥ 18 years
- •WHO performance status 0-2
- •Baseline PRO questionnaires have been completed
- •Adequate bone marrow function: neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 100x 10^9/L
排除标准
- •Any other histological component than seminoma
- •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
- •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
- •Elevated levels of Alpha-1-Fetoprotein AFP (≥ 2x ULN)
- •Involved nodes (metastatic) in previously irradiated localizations in the abdomen or pelvis
- •Any anti-cancer therapy after primary tumor resection in patients presenting with primary stage IIA/B seminoma
- •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)
- •Any treatment in a clinical trial within 28 days prior to registration
- •Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or contraindicated for use with radiotherapy
- •Known hypersensitivity to trial drugs or to any component of the trial drugs
- •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
结局指标
主要结局
Progression free survival (PFS) at 3 years
Progression free survival (PFS) at 3 years
次要结局
- Response rate (RR)
- Progression free survival (PFS)
- Time to progression (TTP)
- Overall Survival (OS)
- Seminoma-specific survival
- Time to distant metastasis
- Time to next treatment
- Localization of progression
- Method of detection of progression
研究者
Competence Center of SAKK
Scientific
Swiss Group for Clinical Cancer Research
研究点 (9)
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