Carboplatin Chemotherapy and Involved Node Radiotherapy in Stage IIA/B Seminoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 25
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
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.
详细描述
INTRODUCTION AND BACKGROUND
- Disease background
Testicular cancers are the most common malignancies in men aged between 18-35 years. Of those, seminoma is the most frequent as it accounts for about half of all testicular cancers. Seminoma is classified according to the involvement of and degree of spreading to lymph nodes and to the lung or other organs. Around 10% of all seminoma patients are diagnosed with stage IIA/B disease. Stage IIA patients have one or more enlarged regional lymph nodes, 2 cm or less in greatest dimension, without evidence of distant disease (cN1 cM0). Stage IIB patients have one or more enlarged regional lymph nodes more than 2 cm but not more than 5 cm in greatest dimension, without evidence of distant disease (cN2 cM0). Paraaortic, interaortocaval, para-/pre-/retrocaval and pre-/retroaortic lymph nodes are considered regional. Intrapelvic, external iliac and inguinal lymph nodes are considered regional only after scrotal or inguinal surgery.
Seminoma stage IIA/B is highly responsive to chemotherapy or radiation therapy and the progression free survival at 5 or 6 years with such treatments is between 87-95%. Supra-diaphragmatic lymph nodes are the usual site of tumor recurrence after radiation therapy, while local failure or tumor persistence in paraaortic lymph nodes is predominant after chemotherapy. 2. Therapy background
Current standard of therapy in patients with stage IIA/B seminoma involves either large volume paraaortic and ipsilateral pelvic radiation therapy ("dogleg field") or three cycles of chemotherapy with BEP (Bleomycin, Etoposide, Cisplatin). While both treatment modalities offer high rates of progression free survival and overall survival, they also potentially bear the risk of unwanted events during and following the treatment. Large volume radiation therapy is associated with fatigue, nausea and vomiting during treatment. BEP chemotherapy causes transient fatigue, cytopenia and hair loss. In terms of late adverse events, radiotherapy increases the risk for permanent kidney and bowel damage, while BEP chemotherapy may harm kidneys, lungs, heart and the inner ear. Both therapy modalities may also lead to secondary tumors. Data on late undesirable effects of large field radiation therapy or intensive chemotherapy will become available in the future at the conclusion of long term follow-up analyses of the recent trials. Thus, the current research on seminoma focuses on minimizing short and long term treatment-related morbidity. 3. Previous trials
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •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-
- •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.
排除标准
- •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).
研究组 & 干预措施
Carboplatin
干预措施: Carboplatin (Drug)
Carboplatin
干预措施: Involved node RT (Radiation)
结局指标
主要结局
Progression free survival (PFS)
时间窗: at 3 years
PFS is defined as the time from registration until one of the following events occurs: * PD or relapse, defined as progression according to the modified trial-specific version of RECIST 1.1 or a rising level of the tumor marker beta-hCG over the ULN (value must be confirmed by a second measurement). Presence of non-seminoma germ cell tumor has to be excluded in the latter case. * Death from any cause.
次要结局
- Late AEs(at the latest at 20 years)
- Incidence of secondary malignancies(at the latest at 20 years)
- Response rate(at 3 years)
- Time to progression (TTP)(at the latest at 20 years)
- Overall survival (OS)(at the latest at 20 years.)
- Seminoma specific survival(at the latest at 20 years)
- PFS(at the latest at 20 years)
- Localization of progression(at the latest at 20 years)
- Adverse events (AEs) temporarily associated with the trial treatment(at 3 years)