araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary

Summary: This is a randomized phase III trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary and a predicted favorable prognosis.
  The purpose of this trial is to compare the overall survival rates of patients with carcinoma of unknown primary (CUP) and a predicted favorable prognosis according to the French classification treated with cisplatin with or without gemcitabine.


Eligibility: Inclusion Criteria:
  -  Patients older than 18 years
  -  Evidence of CUP based on histologic examination
  -  Negative search for the primary tumor site using recommended guidelines
  -  Disease classified as good prognosis according to the French classification criteria: *performance status >2 and *normal serum LDH
  -  No prior chemotherapy
  -  No previous carcinoma, except basal-cell carcinoma of the skin
  -  Adequate renal function: measured or calculated creatinine clearance > 60 ml/min
  -  Absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold the upper normal value
  -  Signed informed consent
  Exclusion Criteria:
  -  Patients infected by the Human Immunodeficiency Virus (HIV)
  -  CUP belonging to one of the following subgroups: 1) Axillary lymph node of an adenocarcinoma in a woman; 2) Serous adenocarcinoma of the peritoneum in a woman; 3) Undifferentiated carcinoma of the middle line in a young man; 4)Squamous-cell carcinoma; 5) Neuroendocrine carcinoma; 6) Bone metastases with elevated serum prostate specific antigen (PSA) in a man
  -  Patients who do not fit inclusion criteria.

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

Clinical trial: A Study to Evaluate the Effectiveness of Imiquimod 5% Cream for Basal Cell Carcinoma Recurrence

Summary: The primary objective of this study is to assess whether basal cell carcinoma (BCC) lesions surgically treated with curettage, followed by imiquimod 5% cream as postsurgical adjuvant therapy, will have an improved cure rate over the ED/C historical norm of approximately 70% at 1-year posttreatment follow-up. A secondary objective is to assess cosmetic outcome.

Detailed description: This was an open-label, phase IIIb, multicenter, single arm, historical-controlled study. Biopsy-confirmed BCC lesions (1 per subject) were excised by curettage, with no electrodessication. Approximately 1 week later, treatment with imiquimod 5% cream was initiated. Imiquimod was applied to the target BCC once daily, 5 times per week (5x/week) for up to 6 weeks. Rest periods were allowed as needed. Subjects reported to the study center at treatment weeks 1, 2, and 6, and posttreatment at weeks 12, 26, and 52. At treatment week 6 and all posttreatment visits, the investigator clinically assessed the target site for tumor clearance and cosmetic outcome. A template made at initiation and created from clear plastic overlay aided in locating the target tumor site. If the investigator identified a lesion that had occurred or recurred at the target site, the subject was discontinued from the study and counted as a recurrence/persistence (R/P).

Eligibility: Inclusion Criteria:
  -  Basal cell carcinoma
  Exclusion Criteria:
  -  Psoriasis

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

Clinical trial: The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas

Summary: This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed uterine sarcoma (rereading in reference centers)
  -  Leiomyosarcoma, adenosarcoma, carcinosarcoma and high grade endometrial stromal sarcoma
  -  All stages <= stage III (FIGO modified for endometrial carcinoma)
  -  Full surgical exeresis
  -  Age >= 18 years and physiological age <= 65 years
  -  Negative extension check-up (thoracic and abdomino-pelvic TDM)
  -  Performance status (PS) <= 2 (ECOG)
  -  Normal haematologic functions (absolute neutrophil count > 1,500/mm3, platelets > 100,000/mm3)
  -  Serum creatinine < 1.25 x ULN
  -  Good hepatic check-up (total serum bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN)
  -  Absence of neuropathy > grade 1
  -  Left ventricular ejection fraction > 50% (by isotopic or ultrasound scan determination)
  -  Written informed consent
  Exclusion Criteria:
  -  Low grade endometrial stromal sarcoma
  -  Time since surgery > 8 weeks
  -  Specific contraindications to the studied treatment (cardiac, kidney, or hepatic ones)
  -  Antecedents or evolutive psychiatric disorder
  -  Concurrent active infection or other serious uncontrolled systemic disease
  -  Antecedents of cancer but a cutaneous basocellular one or an in situ epithelioma of the cervix

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

Clinical trial: Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

Summary: An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.

Detailed description: Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.

Eligibility: Inclusion Criteria:
  -  Have at least 1 previously untreated superficial basal cell carcinoma tumor
  -  Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm
  Exclusion Criteria:
  -  Evidence of clinically significant, unstable medical conditions
  -  Cannot have recent use of topical steroids or retinoids in the treatment area.

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

Clinical trial: Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer

Summary: The purpose of this study is to find out whether adding ZD1839 to standard treatment (Cisplatin and Radiation Therapy) of unresectable head and neck cancers is better than cisplatin and radiation alone.

Detailed description: This is a Phase I-II, open-label, dose-escalation study in subjects with advanced head or neck cancer. Subjects will receive daily ZD1839 during a course of standard radiation therapy accompanied by cisplatin.
  Subjects are adults with Stage III-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, who are in medically stable condition, with an Eastern Cooperative Oncology Group (ECOG) Performance Status of £ 1, stable hepatic and bone marrow function, and a life expectancy of at least 6 months. Subjects should have no previous cancer history (with the exception of squamous cell carcinoma of the skin or cervical cancer in situ) and no prior treatment with radiation, chemotherapy, or definitive surgical therapy. Subjects in the Phase II portion of the trial must have measurable disease as defined by RECIST criteria.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. For the Phase II portion of the study: measurable disease as based on RECIST criteria.
  -  Stage III or IV disease, M0.
  -  Life expectancy > 6 months.
  Exclusion Criteria:
  -  Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
  -  Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of squamous cell carcinoma of the skin or cervical cancer in situ.
  -  Previous treatment with radiation, chemotherapy, or definitive surgical therapy.
  -  Distant metastatic disease.
  -  Documented evidence of HIV infection (because the interaction of ZD1839 with Highly Active Anti-Retroviral Therapy [HAART] is unknown).
  -  Substance abuse or psychiatric problems that would interfere with compliance.
  -  Pregnancy or breast-feeding (women of child-bearing potential).
  -  Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  -  Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)

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

Clinical trial: Debulking Effect of Curretage on Basal Cell Carcinomas - a Histological Assessment.

Summary: The aim of this study was to compare histologically observed tumour infitration of basal cell carcinoma (bcc) lesions before and after curretage.A significant reduction of tumour depth would enable further bcc's included for superficial non-invasive treatment modalities such as topical photodynamic therapy.


Eligibility: Inclusion Criteria:
  -  bcc with tumour depth two mm.or more
  Exclusion Criteria:
  -  bcc tumours smaller than three mm in mean diameter.

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

Clinical trial: Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR

Summary: The purpose of this study is to determine whether cetuximab is effective in the treatment of locally advanced or metastatic squamous cell carcinoma of the skin expressing EGFR.

Detailed description: Patients with locally advanced or metastatic squamous cell carcinoma (SCC) of the skin are often bad responders to conventional chemotherapy included cisplatin.
  The investigation of the EGFR expression may allow identifying new molecular targets for novel therapeutic strategies in patients with locally advanced or metastatic SCC of the skin.
  Several publications in the literature for primary lesions and one publication for metastatic lesions showed that EGFR was expressed in 80-90% of SCC of the skin. Immunohistochemistry studies performed at the Gustave Roussy Institute confirm these data: they found an over-expression of EGFR in 90% of patients with metastatic disease. These results are in favor of the investigation of cetuximab in patients with locally advanced or metastatic SCC of the skin expressing EGFR.
  Cetuximab is a monoclonal antibody targeted against EGFR administered weekly by intravenous route; it may be prescribed as out hospital to patients with locally advanced or metastatic SCC of the skin expressing EGFR.
  Due to the low occurrence of locally advanced or metastatic SCC of the skin, a multicenter trial will be required.

Eligibility: Inclusion Criteria:
  -  Histological SCC of the skin expressing (IHC) moderately or highly the EGFR (++ and +++, on a semi-quantitative scale).
  -  Locally advanced or metastatic SCC of the skin not suitable for local surgery with documented progression.
  -  Presence of at least one measurable target lesion by RECIST criteria.
  -  At least one lesion accessible to biopsies.
  -  ECOG Performance status < 2.
  -  Life expectancy > 3 months.
  -  Age > 18 years.
  -  Normal hematological (Neutrophils > 1.5x109 cells/l, platelets > 100x109 cells/l), hepatic (bilirubin < 1.5 times the upper limit of the normal range (ULN); alkaline phosphatase and transaminases < 5 x UNL in case of hepatic metastases or < 2.5 x UNL in absence of hepatic metastases) and renal (serum creatinine < 150 micromol/L) functions.
  -  Written informed consent.
  -  In case of second tumor,excepted carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma, the possibility for including a patient may be discussed with the principal investigator.
  Exclusion Criteria:
  -  Prior chemotherapy
  -  Prior radiotherapy < 1 month.
  -  Prior therapy with agent targeting EGFR
  -  Unstable systemic diseases or active uncontrolled infections.
  -  Patients (male and female) not using effective contraception if of reproductive potential.
  -  Females pregnant or lactating. Women of child bearing potential must have a negative serum or urine pregnancy test prior to start each cycle of treatment.

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

Clinical trial: The Final Diagnosis and Treatment Result of Metastatic Cervical Carcinoma of Unknown Primary

Summary: Investigate the final diagnosis and treatment result of metastatic cervical carcinoma of unknown primary

Detailed description: Carcinoma of unknown primary (CUP) is defined as biopsy-proven metastasis of an epithelial malignancy in the absence of an identifiable primary site after complete history and physical examination, basic laboratory studies, chest X-ray and additional directed studies indicated by positive findings during the initial work-up. It is characterized by its slow local development and its high metastatic potential.1,2 Patients with CUP represent 4–10% of all new cancer patients.3,4 The presenting sites of metastasis identified pathologically, radiographically or by physical examination were found most frequently in the lymph nodes (37.1%), followed by the liver, bone, lung, pleura/pleural space, brain, peritoneum, adrenal and skin. Of the lymph nodes of metastasis, the supraclavicular cervical area is the leading site (31.3%), followed by the mediastinum, axilla, retroperitonium, and inguina.5 The incidence of metastatic cervical CUP (MCCUP) varies between 2% and 9% of all head and neck cancers.6-8 The level of cervical metastatic involvement may give some clue as to the likely primary site. A submandibular mass (level I) would most commonly be related to a primary in the oral cavity or skin. Level II nodes, including the jugulodigastric node, may point to a primary in the oral cavity, oropharynx, or supraglottic larynx. Tumours of the nasopharynx generally spread to level II or the posterior triangle, as well as retropharyngeal nodes. Middle and lower jugular nodes (levels III and IV) are more likely related to a laryngeal or hypopharyngeal cancer. Metastatic disease restricted to the supraclavicular region is often due to an infraclavicular primary site.9 The prognosis is different according to the involved lymph node level and possible primary site. Modern cancer management relies heavily on recognition of the primary tumor; thus the absence of a primary site poses major diagnostic and therapeutic problems. The patient benefits from identification of the initial tumor site because postoperative irradiation ports may be reduced and because surveillance for recurrence may be improved.10 In order to identify the likely primary site of MCCUP and compare the prognoses of known and unknown primary groups, we report the results according to the different levels of metastatic cervical lymph nodes.

Eligibility: Inclusion Criteria:
  -  cases of metastatic cervical carcinoma of unknown primary
  Exclusion Criteria:

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

Clinical trial: Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage

Summary: To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage

Detailed description: The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream on nodular BCC lesions treated 5x/week for 6 weeks after primary treatment with curettage without electrodesiccation. The secondary objective of this study is to evaluate the cosmetic outcome after treatment of the lesions using this modality.

Eligibility: Inclusion Criteria:
  1. Are willing and able to give informed consent;
  2. Are at least 18 years of age;
  3. Are willing to comply with all study requirements, evaluations, and procedures
  4. Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria:
  -  a primary lesion (not recurrent, not previously treated or biopsied)
  -  non-infected
  -  size between 0.25 and 1.5 cm2
  -  located at least 1 cm from the eyes, nose, mouth, ear, and hairline to exclude the H-zone of the face
  -  clinically consistent with nodular BCC
  -  histologically consistent with nodular BCC and have no histological evidence of a morpheaform or micronodular pattern
  -  suitable for treatment with surgical excision
  -  easily identifiable and treatable by subject or reliable subject representative
  5. Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
  6. Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits.
  Exclusion Criteria:
  1. Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study.
  2. Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
  3. Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
  4. Are pregnant at the screening or treatment initiation visit.
  5. Have known allergies to any excipient in the study cream
  6. Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.

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

Clinical trial: Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

Summary: Basal like breast carcinoma is a Her2, estrogen receptor (ER) progesterone receptor (PR) negative breast cancer. It is notable for the high level of epidermal growth factor receptor (EGFR) expression in this tumor subtype .
  Thus the investigators wanted to combine the use of anti EGFR therapy in the form of Erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of these women. This is a small phase I/II study.

Detailed description: Basal like breast carcinoma is a Her2, ER PR negative breast cancer. It is notable for the high percentage of EGFR expression in this tumor subtype.Weekly taxol (paclitaxel) is widely used in breast cancer patients with metastatic disease. Erbitux (cetuximab) is a monoclonal antibody that shown its ability to enhance activity of chemotherapy in colon carcinoma. Thus we wanted to combine the use of anti EGFR therapy in the form of Erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of women with basal like breast carcinoma. This is a small phase II study that will hopefully provide initial data as to the general tolerability and response rate of this combination in this disease. Furthermore, pathologic analysis will be used to try and assess relation of response with the presence of immunohistochemical markers such as EGFR expression.

Eligibility: Inclusion Criteria:
  -  Patients with metastatic breast carcinoma of the basal like subtype with available biopsy for analysis and ECOG PS of 2 or less
  Exclusion Criteria:
  -  Pregnancy
  -  BUN, blood creatinine, AST, ALT > X3 of upper limits of normal
  -  More than previous 2 chemotherapy lines in the metastatic settings or the use of previous inhibitors of EGFR

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

Clinical trial: To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC

Summary: The purpose of this study is to determine maximum tolerated dose level (MTD) of PEP005 Topical Gel for the treatment of superficial basal cell carcinoma on the trunk

Detailed description: Basal cell carcinomas (BCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation and simple excision, which are often cosmetically disfiguring. Non-invasive alternative therapy for treatment of BCC lesions is thus being researched. Sap from the plant Euphorbia peplus has been used for many years in Australia as a "folk" remedy to treat a number of skin conditions. The active component of Euphorbia peplus has been isolated and made into a gel applied directly to the skin by Peplin Opeation Pty Ltd.
  The proposed study follows a previously conducted 12 week study in sBCC, PEP005-003. This was a two dose schedule evaluating doses up to 0.05%. Histological clearance rate at the end of study was 71% for the 0.05% concentration on the Day 1, Day 2 schedule compared with 0% in the vehicle group.
  The proposed study aims to determine the maximum tolerated dose level (MTD) of PEP005 Topical Gel, in patients, when administered either as a single application or as two applications to a selected superficial basal cell carcinoma lesion with a 3 month follow up.

Eligibility: 1. Male or female patients at least 18 years of age.
  2. A primary clinically diagnosed and histologically confirmed sBCC lesion located on the trunk which is suitable for excision the histological diagnosis should be made no more than 60 days prior to the screening visit the biopsy specimen should have removed no more that 20% of the total tumour mass
  3. Ability to follow study instructions and likely to complete all study requirements.
  4. Written informed consent has been obtained.
  5. Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package.

Relevance to patient case: not relevant