araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib

Summary: This study will allow for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.

Detailed description: This protocol is a sub-protocol of an interventional study. Because the main study is interventional, this study was approved by FDA as an interventional study. It cannot stand alone without the parent study. The sites will receive diagnostic information for all patients that come on study.

Eligibility: Inclusion Criteria:
  -  Written informed consent must be obtained prior to any baseline/screening procedures.
  -  Patients eligible for this companion sample collection protocol sample collection protocol must meet all inclusion in CLEE011A2404.
  Exclusion Criteria:
  -  Patients eligible for this companion sample collection protocol must not meet any of the exclusion criteria in the CLEE011A2404 study, in addition to the following:
  -  Patients without either fresh or archival tumor tissue accessible.

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma

Summary: Gamma GBM is a single-arm phase II trial that prospectively measures the progression-free survival time after addition of an early gamma knife boost to areas of residual tumor to standard-of-care (surgery, chemo-radiotherapy, chemotherapy).

Detailed description: Glioblastomas are highly malignant brain tumors that recur about 6 months after treatment. Most recurrences develop at the edge of the surgical margin and a common reason for an early recurrence of a glioblastoma is when tumors are not completely resected. This may be the case when intraoperative neuro-monitoring indicates that further resection would impair certain motor functions. Physicians can identify residual tumor in early (24-72h after surgery) postoperative MRI scans and could treat these regions. However, this treatment would not be a part of the recommended standard of care and thus, any further treatment of this areas will need a clinical trial.
  The aim of this trial is to evaluate if the use of another modality to deplete these areas of residual tumor identified in early postoperative MRI scans will provide a relevant benefit in terms of progression-free survival (which means a prolongation of the time that patients do not experience a re-growth of the tumor). The modality is termed "radiosurgery", which is a non-invasive technique to delete cells without using a blade but a highly focused beam of gamma rays.
  The machine that focusses these rays (like a magnifying glass that can focus light), is called 'gamma knife'. Gamma knife radiosurgery is a safe and effective treatment for a plethora of malignant and benign brain tumors and the technique is used since the 1950s and there has been a continuous improvement of precision and patient comfort up to now.

Eligibility: Inclusion Criteria:
  -  Age ≥ 18
  -  Karnofsky performance status score ≥ 60
  -  histology must be glioblastoma (frozen sections during surgery)
  -  radiographic proof of residual tumor
  -  Informed consent
  -  adequate birth control (e.g., oral contraceptives)
  Exclusion Criteria:
  -  any previous cranial radiotherapy
  -  histology inconclusive or low(er)-grade astrocytoma
  -  contraindications for chemo- or radiotherapy
  -  bleeding or clotting disorders
  -  contraindications for MRI or CT scans

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Efficacy and Safety of Treatment With Alpelisib Plus Endocrine Therapy in Patients With HR+, HER2-negative aBC, With PIK3CA Mutations, Whose Disease Has Progressed on or After CDK 4/6 Treatment With an Aromatase Inhibitor (AI) or Fulvestrant

Summary: Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6 treatment with an aromatase inhibitor (AI) or fulvestrant


Eligibility: Inclusion Criteria:
  -  patient is male or female 18 years or older
  -  Patient is identified PIK3CA mutant status
  -  Patient has confirmed HER2-negative advanced breast cancer (aBC)
  -  Patient must be diagnosed with aBC with documented progression on or after CDK 4/6 treatment (adjuvant or metastatic setting)
  -  Patient has histological and/or cytological confirmed ER+ and/or PgR+ aBC
  -  Patient has either measurable disease per RECIST v1.1 or at least one predominantly lytic bone lesion must be present
  -  ECOG function of greater or equal to 2
  -  Patient has adequate bone marrow function
  -  Patient has adequate liver and renal function
  Exclusion Criteria:
  -  patient has received prior treatment with any PI3K inhibitors
  -  patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
  -  Patient has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanoma skin cancer or curatively resected cervical cancer
  -  Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to enrollment, and who has not recovered to grade 1 or better from related side effects of such therapy
  -  History of acute pancreatitis within 1 year of screening or past medical history of pancreatitis
  -  Bilateral diffuse lymphangitis carcinomatosis
  -  Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
  -  At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment
  -  Clinically stable CNS tumor at the time of screening untreated or without evidence of progressions for at least 4 weeks after treatment as determined by clinical examination and brain imaging (MRI or CT) during screening period and stable low dose of steroids for 2 weeks prior to initiating study treatment
  -  Patient with severe liver impairment (Child Pugh score B/C
  -  Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
  -  Patient has documented pneumonitis which is active and requiring treatment

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer

Summary: RATIONALE: Giving fluconazole may be effective in preventing or controlling mucositis caused by radiation therapy to the head and neck.
  PURPOSE: Randomized phase II/III trial to study the effectiveness of fluconazole in preventing mucositis in patients undergoing radiation therapy for head and neck cancer.

Detailed description: OBJECTIVES:
  -  Determine the effect of prophylactic antifungal therapy with fluconazole on the incidence and severity of radiation-associated mucositis/thrush in patients with head and neck cancer undergoing definitive radiotherapy.
  OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo standard hyperfractionated radiotherapy 5 days a week for 5-5.6 weeks. Patients receive oral fluconazole on days 1-4 and 28-31 of radiotherapy.
  -  Arm II: Patients undergo radiotherapy as in arm I. Patients who develop a microbiologically proven fungal infection or clinically evident oral cavity and/or oropharyngeal thrush may receive fluconazole as in arm I.
  PROJECTED ACCRUAL: At least 42 patients (26 per arm) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven head and neck cancer undergoing definitive radiotherapy
  PATIENT CHARACTERISTICS:
  Age:
  -  Over 21
  Performance status:
  -  Karnofsky 70-100%
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  SGOT and SGPT less than 2 times normal
  -  Alkaline phosphatase less than 2 times normal
  Renal:
  -  Not specified
  Other:
  -  No history of hypersensitivity to fluconazole
  -  HIV negative
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified
  Other
  -  At least 2 months since prior antifungal agents
  -  Not currently receiving phenytoin, hydrochlorothiazide, or warfarin
  -  If these medications are initiated during study therapy, medication serum levels and electrolytes are monitored for possibility of drug interaction

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Photodynamic Therapy in Treating Patients With Skin Cancer

Summary: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be effective in treating patients with skin cancer.
  PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in treating patients with skin cancer.

Detailed description: OBJECTIVES:
  -  Characterize the penetration of topically applied aminolevulinic acid (ALA) into the lesions of patients with primary basal cell and squamous cell carcinomas.
  -  Quantitate the depth of fluorescence achievable with varying application periods of ALA in these patients.
  -  Compare the results of tissue fluorescence with surface fluorescence measurements in these patients.
  OUTLINE: This is a randomized study. Patients are stratified according to lesion type (superficial basal cell carcinoma (BCC) vs nodular BCC vs squamous cell carcinoma). Patients within each group are randomized to receive one of two application times: 4-5 or 20-24 hours in duration.
  Aminolevulinic acid is topically applied either in a cream mixture or an alcohol base and an occlusive dressing placed over the lesion. After the randomized treatment duration has expired, the dressing is removed and quantitative protoporphyrin IX fluorescence measurements from the tumor and surrounding skin are mapped using a fluorometer. Routine surgical excision is then performed on the carcinoma.
  Patients return after one to two weeks for a follow-up examination and suture removal.
  PROJECTED ACCRUAL: 54 patients will be accrued within 10 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven basal cell carcinoma or squamous cell carcinoma
  -  Candidate for complete surgical excision
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No inflammation or infection of treated area
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Biopsy at least 2 weeks prior to surgery

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: High-Dose Multivitamins Compared to a Placebo in Preventing the Recurrence of Cancer in Patients With Early Stage Bladder Cancer

Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of high-dose multivitamins may be an effective way to prevent the recurrence of early stage bladder cancer. It is not yet known whether high-dose vitamins are more effective than no further therapy in decreasing the risk of early-stage bladder cancer.
  PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of high-dose multivitamins with a placebo in preventing the recurrence of cancer in patients with early stage bladder cancer.

Detailed description: OBJECTIVE: I. Determine whether high dose multivitamins have chemopreventive efficacy beyond standard therapy in reducing the risk of recurrence in patients with resected stage 0 and I (Ta, T1, and Tis) transitional cell carcinoma of the bladder.
  OUTLINE: This is a randomized, double blind study. Patients are randomized to receive multivitamins or placebo orally once daily for 3 years. Patients are followed every 3 months for 2 years, then every 6 months for 1 year, and then annually thereafter.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed stage 0 and I (Ta, T1 or Tis) resected transitional cell carcinoma of the bladder No advanced disease or muscle invasion No history of transitional cell carcinoma of the prostate
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Greater than 3 years Hematopoietic: WBC at least 3500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception At least 5 years since prior malignancy except nonmetastatic squamous cell or basal cell carcinoma of the skin No history of drug interactions which could affect therapy No immunodeficiency
  PRIOR CONCURRENT THERAPY: Biologic therapy: Prior intravesical BCG required (if T1 or Tis pathology and negative cytology PAB) Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the pelvis Surgery: Not specified Other: Intravesical therapy within 30 days allowed At least 30 days since greater than 2 multivitamins daily

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic cancer of the urinary tract.

Detailed description: OBJECTIVES: I. Determine the objective response to nitrocamptothecin in patients with metastatic urothelial tract tumors. II. Determine the response rate in these patients when treated with this regimen. III. Determine the duration of objective response in these patients when treated with this regimen. IV. Characterize the toxicities of this treatment in this patient population.
  OUTLINE: This is a multicenter study. Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression.
  PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable primary carcinoma of the urinary tract including bladder, ureter, and renal pelvis Transitional cell carcinoma OR Mixed cell carcinoma OR Squamous cell carcinoma OR Adenocarcinoma Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan No symptomatic brain metastases
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN in case of hepatic metastases) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: Normal cardiac function No ischemic disease in past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancies except cone biopsied carcinoma of the cervix or adequately treated basal or squamous cell skin carcinoma No concurrent unstable systemic disease or active uncontrolled infection No psychological, familial, sociological, or geographical condition that would preclude study
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Must have received 1 prior chemotherapy regimen for advanced or metastatic disease At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 14 days since prior major surgery Other: No other concurrent anticancer agents No other concurrent investigational therapy

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.

Summary: The purpose of the two studies is to determine whether an experimental therapy using a photoactive drug, verteporfin, in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors.

Detailed description: Basal cell carcinoma (BCC) of the skin is the most common type of cancer that can be treated with various therapies including surgical removal. A number of factors can lead to the development of multiple BCC of the skin, including genetic disorders (e.g., nevoid basal cell carcinoma syndrome). Treatment of multiple BCC becomes much more challenging. In these trials, the experimental therapy: verteporfin PDT is compared to placebo PDT. PDT or photodynamic therapy in these studies is the combination of the photoactive drug verteporfin (given intravenously) and red light exposure of skin tumors.
  The primary objective is to assess whether verteporfin PDT can completely eliminate multiple BCCs. Eligible subjects will have at least 3 BCCs. Study subjects won't know which treatment they have been been assigned to - this is done randomly (like flipping a coin). After study treatment, the BCCs in each subject will be closely observed and toward the end of the study all will be surgically removed and examined to verify response to study treatment. Safety will be assessed by testing blood samples before and after study treatment, and analyzing adverse events and skin reactions to the study treatment.

Eligibility: Inclusion Criteria:
  -  Currently has at least 3 eligible BCC skin tumors that have never been treated
  -  Is willing to have these tumor sites surgically removed
  Exclusion Criteria:
  -  Has xeroderma pigmentosum
  -  Has BCC tumors that are the result of prior radiotherapy or immunosuppression due to an organ transplant
  -  Is immunosuppressed
  -  Has abnormal liver function
  -  Is receiving systemic chemotherapy or has received chemotherapy within the last two years

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Acupuncture or Standard Therapy in Treating Pain and Dysfunction in Patients Who Have Undergone Neck Surgery for Head and Neck Cancer

Summary: RATIONALE: Acupuncture may help relieve pain and dysfunction caused by cancer surgery. It is not yet known whether acupuncture is more effective than standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer.
  PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared to standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine whether acupuncture reduces pain and dysfunction in patients with head and neck cancer who have undergone neck dissection.
  Secondary
  -  Determine whether acupuncture relieves dry mouth in these patients.
  OUTLINE: This is a randomized, controlled study. Patients are stratified according to surgical procedure (selective neck dissection vs modified radical neck dissection vs radical neck dissection) and baseline Constant-Murley score (≤ 35 vs > 35). Patients are randomized into 1 of 2 treatment arms.
  -  Arm I: Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.
  -  Arm II: Patients undergo standard of care for 4 weeks. In both arms, treatment continues in the absence of unacceptable toxicity.
  The Constant-Murley score is assessed at baseline and then at week 6. Pain medication use is recorded at baseline, during study treatment, and then at week 6. Numerical Rating Scale of pain on activity and xerostomia inventories are completed at baseline and then at weeks 5 and 6.
  After completion of study treatment, patients are followed periodically.
  PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Must have undergone neck dissection for cancer ≥ 3 months ago (in order to qualify pain as chronic sequella)
  -  Subjective complaint of pain and/or dysfunction in the neck and/or shoulders that, in the opinion of the investigator, is due to neck dissection
  -  Constant-Murley score ≤ 70 (i.e., moderate or severe pain and dysfunction)
  -  No moderate or severe neck or shoulder pain that, in the opinion of the investigator, is not due to cancer surgery
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  At least 3 months since prior radiotherapy
  -  More than 6 weeks since prior acupuncture
  -  Concurrent analgesics allowed

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: A Research Study for Patients With Metastatic Renal Cell Carcinoma

Summary: The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy.


Eligibility: Inclusion Criteria:
  Patients must fulfill all of the following criteria to be eligible for study participation:
  -  Age ≥ 18 years;
  -  Histologically confirmed Renal Cell Carcinoma (RCC);
  -  Metastatic disease, with measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST);
  -  Failure of prior cytokine therapy;
  -  Documented progressive disease;
  Exclusion Criteria:
  Patients are ineligible for entry if any of the following criteria are met:
  -  Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
  -  History of serious ventricular arrhythmia
  -  Corrected QT interval (QTc) ≥ 500 msec
  -  Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;
  -  Previous extensive radiotherapy involving ≥ 30% of bone marrow
  -  Coexistent second malignancy or history of prior malignancy within previous 5 years

Relevance to patient case: not relevant