araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: The Pilot Study Evaluate the Safety and Efficacy of Sirolimus in Patients With PIK3CA Mutation and/or PIK3CA Amplification Refractory Solid Tumors

Summary: This study is a single-arm, phase II study of sirolimus in patient with PIK3CA mutation and PIK3CA amplication Refractory solid tumors.
  sirolimus 1mg will be administered orally qd daily.
  To investigate the efficacy of sirolimus in patients with PIK3CA mutation and PIK3CA amplication Refractory solid tumors.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. PIK3CA amplification and/or PIK3CA mutation Refractory Solid Tumors.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer

Summary: This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in combination with selumetinib in KRASm NSCLC; and PART B - a randomized phase II study investigating the progression free survival and safety of selumetinib/afatinib combination therapy compared to standard of care chemotherapy in KRASm NSCLC.


Eligibility: Inclusion Criteria:
  -  Histological or cytological proof of advanced NSCLC; for PART B: treated with first line therapy for metastatic disease only.
  -  Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wildtype (defined as absence of mutations in exon 9 and 20)
  -  Able and willing to give written informed consent
  -  Able and willing to undergo blood sampling for PK and PD analysis
  -  Life expectancy >=3 months allowing adequate follow up of toxicity evaluation and antitumor activity.
  -  WHO performance status of 0 or 1.
  -  Able and willing to undergo a tumor biopsies prior to start, after two weeks (part A only) and upon progression of disease
  -  Measurable disease according to RECIST 1.1
  -  Adequate organ system function measured by laboratory values
  Exclusion Criteria:
  -  Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
  -  History of another malignancy Exception PART A: Patients who have been disease-free for at least 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent second malignancies are eligible. Exception PART B: Adequately treated carcinoma in situ of the cervix and adequately treated basal cell carcinoma of the skin. 3. Symptomatic or untreated leptomeningeal disease.
  -  Symptomatic brain metastasis.
  -  Patients previously treated with any drug combination known to interfere with EGFR, HER2, HER3, HER4 or MAPK- and PI3K-pathway components, including inhibitors of PTEN, PI3K, AKT, mTOR, BRAF, MEK and ERK.
  -  History of interstitial lung disease or pneumonitis
  -  Radio-, immuno- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed.
  -  Opthalmological diseases
  -  Patients with left ventricular ejection fraction (LVEF) < 55%
  -  Patients with cardiac comorbidities
  -  Concomitant or recent use (in the past 14 days) of strong inhibitors and inducers of CYP1A2, CYP2C19, CYP3A4, 3A5 and P-glycoprotein (P-gp)

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: RhGM-CSF as Adjuvant Immunotherapy in Treating Stage III Colon Cancer

Summary: This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers.

Detailed description: This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers. Patients were randomly assigned to rhGM-CSF group or placebo group and treated with rhGM-CSF or placebo perioperation and during the adjuvant chemotherapy. The purpose of the study is to evaluate the antitumor immune effect of rhGM-CSF before surgery and adjuvant chemotherapy through DFS of 5 years and to observe the safety during the treatment in order to provide evidence for improvement in treating resectable colon cancer patients.

Eligibility: Inclusion Criteria:
  1. Diagnosed as resectable stage III colon cancer
  2. 18-70 years old
  3. ECOG performance status ≤2
  4. Unexposed to rhGM-CSF in 6 months
  5. Signed an informed consent document
  Exclusion Criteria:
  1. Secondary primary cancer, or concurrent primary malignancies (except for basal cell or squamous cell skin cancer, cervical cancer in situ, and other cancer with disease free for more than 5 years)
  2. Complete intestinal obstruction
  3. Events within 6 months before randomization: myocardial infarction, sever or unstable angina, coronary artery or peripheral arterial bypass surgery, congestive heart failure ( NYHA functional class of III or IV ), stroke and any myocardial dysfunction in a transient ischaemic attack
  4. Abnormal liver and kidney function (Serum creatinine > 1.5 x ULN, total bilirubin > 1.5 x ULN, transaminase > 3 x ULN ), abnormal pulmonary function (FEV1<60% or diffusing capacity of the lung for carbon monoxide < 55% )
  5. Bone marrow dysfunction ( Hb<9.0 g/dL、ANC<1.5 x 109/L、PLT<100 x 109/L )
  6. ITP or immunodeficiency
  7. Uncontrolled infection, including HBV, HCV, HIV infection
  8. Female patients who has been pregnant or planning to, and those during lactation
  9. Known allergic to E.coli agents or rhGM-CSF or any severe allergic history to other drugs
  10. Other cases that the researcher found ineligible

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients

Summary: The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients by a randomized, parallel-group, double-blind, multicenter clinical study.

Detailed description: Although many therapies exist and are being developed to relieve symptoms for colon cancer, there are few randomized controlled clinical trials to evaluate comprehensive Traditional Chinese medicine (TCM) interventions in colon cancer. The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients. This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the synergistic anti-tumor effect of TCM on colon cancer patients. Following a run-in period, approximately 360 subjects will be randomly assigned to conventional chemotherapy treatment group, ChangTai Keli and conventional chemotherapy treatment group for 26 weeks. After the 26 weeks treatment period, subjects in two treatments arms will follow-up 36 months.

Eligibility: Inclusion Criteria:
  1. collaboration from hospital oncology patients in hospital. Confirmed by pathology or cytology for colon cancer, Ⅱ A - Ⅳ period of patients with colon cancer line (or late postoperative palliative chemotherapy).
  2. age > 18 years of age, and the 75 - year - old patient or less;
  3. fitness score (ECOG PS) 2 minutes or less, expected lifetime > 6 months;
  4. volunteered for the clinical research, and sign the informed consent.
  Exclusion Criteria:
  1. patients with other primary malignant tumors within 1 year;
  2. intentional, severe liver and kidney disease patients with serious obstacle and function;
  3. pregnancy or lactation women, mental disorders to cooperate to complete the healer;
  4. is in other subjects or attended other drugs test interval < 3 months.
  5. do not meet the inclusion criteria;

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: QoLiCOL - Quality of Life in Colon Cancer

Summary: All patients presenting at participating hospitals during the recruitment period with a newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for inclusion. They will answer a questionnaire on health related quality of life, physical symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36 months. Clinical data including recurrence, survival, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal Cancer Registry (SCRCR)

Detailed description: QoLiCOL is an explorative, prospective, longitudinal, non-interventional, international, multicenter study of health-related quality of life, physical symptoms, functional impairments and socioeconomic burden in colon cancer patients. All patients presenting at participating hospitals during the recruitment period with a newly diagnosed rectal cancer, regardless of stage and planned treatment, will be eligible for inclusion. Patients will be followed for 3 years. They will be asked to answer questionnaires at three different time points during follow-up: at diagnosis and after 12 and 36 months. Clinical data, including recurrence, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the national quality registry for rectal cancer in Denmark and Sweden. As these registries differ in some areas between the countries, additional data will be collected through short CRF:s.

Eligibility: Inclusion Criteria:
  -  Colon cancer newly diagnosed.
  -  Planned treatment presented
  Exclusion Criteria:
  -  No Colon cancer diagnosis,
  -  below 18 years of age,
  -  no informed consent or withdrawn informed consent.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cancer

Summary: Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety profile of panitumumab in patients affected by Head and Neck cancer after at least one cisplatin or carboplatin-based chemotherapy. A translational research study is also planned to evaluate EGFR status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA sequencing, PTEN protein expression by immunohistochemistry, and HPV genotyping by reverse hybridization.
  Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive disease, unacceptable toxicity, pregnancy, or patient's refusal


Eligibility: Inclusion Criteria:
  -  ECOG performance status 0-2, not pregnant.
  -  Histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck either metastatic or recurrent, judged incurable by surgery or radiation.
  -  Baseline tumor tissue, sufficient material available for EGFR determination (therapeutic target of panitumumab) and biomarker studies. Patients without available tissue at baseline or with tissue collected longer than 1 year before, may undergo tumor biopsy.
  -  Progression after or not responding to treatment with at least one cis-platin or carboplatin containing regimen.
  -  Measurable disease (RECIST 1.1).
  -  Adequate hematological values, renal and hepatic function.
  -  Patients may not be receiving any other investigational agents
  Exclusion Criteria:
  -  Platinum-naïve patients.
  -  Patients previously progressed after a regimen containing EGFR-inhibiting agents (as cetuximab, panitumumab, gefitinib, erlotinib), even if there was an initial response.
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year before enrollment/randomization.
  -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  -  Known or suspected brain metastases.
  -  Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent
  -  Known hypersensitivity to panitumumab active ingredient or excipients.
  -  Any concomitant drugs contraindicated for use with the trial drug according to the Swissmedic approved product information - HIV positive patients

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors

Summary: This study is a single arm, pilot study of sirolimus in patient with Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of sirolimus in patient with Refractory solid tumor.


Eligibility: Inclusion Criteria:
  -  Provision of fully informed consent prior to study specific procedures.
  -  Patients must be >= 19 years of age
  -  Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration( H1047R, E542K, E545K, PTEN LOSS) Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  ECOG Performance status0-2
  -  Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
  -  Adequate Organ Function Laboratory values
  -  Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=75 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL
  -  Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  -  Adequate heart function
  Exclusion Criteria:
  -  Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
  -  Has known active central nervous system(CNS) metastases
  -  Has an active infection requiring systemic therapy
  -  Pregnancy or breast feeding
  -  Patients with cardiac problem
  -  Any previous treatment with sirolimus

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Colorectal Cancer: Screening vs. Non-Screening

Summary: The purpose of this study is to determine whether colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after immunochemical based faecal occult blood test) has more favourable clinical-pathological characteristics than colorectal cancer diagnosed for symptoms. We aimed to compare these two groups of patients at the time of diagnosis and confirm the efficiency of the screening programme.

Detailed description: Multicentre prospective observational study. 12 centres across the Czech rep. included. Study approved by Ethical Committee.
  All participants gave their informed signed consent. Each centre was assigned a unique ID number to distinguish between the locations in which patients were enrolled.
  Patients informations were stored under identification number in secure internet database (RedCap) run by The International Clinical Research Center of St. Anne's University Hospital Brno.REDCap is a secure, web-based application designed to support data capture for research studies.
  Statistical analysis was done with SAS, ver. 9.3. Descriptive statistics such as absolute and relative frequencies and median with 95 % confidence intervals were used. Differences between the screening and non-screening groups were compared using the Chi-square test or Fisher's exact test (categorical parameters) and Mann-Whitney test (continuous parameters). Results with a p-value < 0.05 were considered statistically significant

Eligibility: Inclusion Criteria:
  -  newly diagnosed colorectal cancer
  Exclusion Criteria:
  -  unsigned informed consent
  -  mental disorder

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Sirolimus and Cyclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and Chondrosarcoma

Summary: Chondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient survival. Current treatment options consist of wide surgical resection, however for patients with a local recurrence or metastatic disease the outcome is poor. New treatment options being evaluated and mouse models show in vivo that mammilian target of rapamycin (mTOR) inhibition can prevent tumour growth. mTOR is an kinase that is present in two complexes and thereby activates multiple pathways. Aberrant mTOR signalling is known to be involved in cancer cell survival. Several clinical studies for patients with bone or soft tissue sarcoma treated with mTOR inhibitors have been conducted and they show promising results. From these studies the investigators can conclude that the combination of an mTOR inhibitor with cyclophosphamide shows promising results in chondrosarcoma. With the lack of other treatment options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the Eurosarc consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according to a common protocol with the combination of sirolimus and cyclophosphamide using the growth modulation index for evaluation in the current clinical study protocol.


Eligibility: Inclusion Criteria:
  -  Pathologically proven conventional chondrosarcoma
  -  Or pathologically proven myxoid liposarcoma with PIK3CA mutation or Phosphatase and tensin homolog (PTEN) loss
  -  Or pathologically proven mesenchymal or dedifferentiated chondrosarcoma
  -  Patient is 18 years and up
  -  Documented radiographic progression of disease according to RECIST 1.1 criteria in last 6 months
  -  Written signed informed consent
  -  Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L)
  -  Availability of archival tumor material for central review or be able to perform a 3 core fresh biopsy
  -  Ability to adhere to the study visits and all protocol requirements
  Exclusion Criteria:
  -  Previously treated with an mTOR inhibitor
  -  Known to be allergic to cyclophosphamide
  -  Life expectancy of less than 3 months
  -  No measurable lesions according to RECIST 1.1
  -  Eastern cooperative oncology group (ECOG) Performance status >2
  -  Major surgery less than 4 weeks prior to start of treatment
  -  Known human immunodeficiency virus (HIV) positivity
  -  A decreased renal function with calculated glomerular filtration rate (GFR) < 30ml/min
  -  Systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to a target lesion within 21 days prior to the first dose of study drug
  -  Pregnant or lactating women
  -  Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localised cured prostate and cervical cancer

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Laparoscopic Surgery for T4 Tumor of the Colon Cancer

Summary: The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer.

Detailed description: The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. However, the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. The aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well as the mortality and the morbidity.
  The number of patients needed to get a 80% power is 1960. The average number of patients/surgical center is approximately 200 in each of 10 surgical centers.
  The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.
  The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.
  Systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy VS conventional open surgery).

Eligibility: Inclusion Criteria:
  -  Able to provide written informed consent
  -  Histologically confirmed diagnosis of colon carcinoma
  -  CT or MRI verified as T4 colon cancer without involvement of other organs
  -  Without multiple lesion other than carcinoma in situ
  -  Tumor size < 8 cm
  -  No bowel obstruction
  -  Sufficient organ function
  -  No history of gastrointestinal surgery
  -  18 years of age or older
  -  Performance Status (ECOG) 0, 1 or 2 and life expectancy > 12 weeks
  -  Operable patients
  Exclusion Criteria:
  -  Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
  -  Unstable or uncompensated respiratory or cardiac disease
  -  Serious active infections
  -  Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
  -  Stomatitis, ulceration in the mouth or gastrointestinal tract
  -  Severe diarrhea
  -  Peripheral sensory neuropathy with functional impairment

Relevance to patient case: not relevant