Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT00707161
Eligibility Criteria:
Inclusion criteria:
* Signed study-specific consent form prior to registration.
* Pathologically confirmed malignant melanoma.
* Measurable melanoma lesion deemed to require radiation by treating physicians for purposes of local control or palliation. The lesion may be the primary melanoma, a nodal metastasis, or a distant metastasis. Recurrent lesions are allowed.
* Lesion has to be measurable clinically or radiographically in 2 dimensions.
* Karnofsky Performance Scale (KPS) \> 70.
* Laboratory values
* White blood cells (WBC) \> 3000/mm3
* Absolute granulocyte count \> 1,500
* Platelets \> 100,000/mm3
* Total bilirubin \< 2.0 x institutional upper limit of normal
* AST or ALT (aminotransferase/alanine aminotransferase) \< 2.5 x institutional upper limit of normal
* Serum calcium \< 1.3 x institutional upper limit of normal
* Serum creatinine \< 1.5 mg/dL or Creatinine clearance \> 50 cc/min,calculated as follows: CCr = 0.85 x (140-age) x (weight in kg) 72 x serum creatinine in mg/dL
Exclusion criteria:
* Systemic therapy for malignant melanoma within one month preceding trial enrollment.
* Prior irradiation to the planned field.
* Concomitant chemotherapy (in addition to cisplatin) or biologic therapy is allowed.
* Significant infection or other co-existent medical condition which would prevent the use of full dose chemotherapy.
* Pre-existing sensory neuropathy (CTC 3.0 ≥ Grade II)
* Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00707161
Study Brief:
Protocol Section:
NCT00707161