- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03482791
Protonisädehoito ruokatorven syövän hoidossa
Vaiheen II tutkimus protonisädehoidosta ruokatorven syövän hoidossa
The investigators plan to include both operable and inoperable patients with esophagus cancer in this prospective trial. Since both proton and photon treatments are biologically equivalent, the investigators do not expect a difference in tumor control compared to intensity modulated radiation therapy (IMRT). The investigators have a prospective experience of physician-reported toxicity and patient outcome using IMRT for patients with inoperable esophagus cancer that will serve as a comparison group. For the resectable patients receiving trimodality therapy (chemoradiation followed by surgery), the investigators will carefully track toxicity and patient outcomes prospectively. The central hypothesis is that the biologic efficacy for tumor control should be similar between protons and photons, and therefore survival measures should be similar between the two groups, but that the main difference lies in the total severe toxicities experienced by the patients undergoing therapy.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Missouri
-
St Louis, Missouri, Yhdysvallat, 63110
- Washington University School of Medicine
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
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Histologically or cytologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
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Staged by PET/CT and esophagogastroduodenoscopy (EGD) or endoscopic ultrasound (EUS) OR CT w/contrast and EGD to have stage II or III disease per AJCC 7th edition guidelines
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Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer (AJCC 7th edition) is eligible, irrespective of margin status.
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Induction chemotherapy prior to concurrent chemoradiation is allowed.
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Prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist.
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At least 18 years of age.
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ECOG performance status < 2
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Normal bone marrow and organ function as defined below:
- WBC > 2,500/mcL
- Platelets > 75,000/mcl
- Total bilirubin < 1.5 x institutional upper limit of normal (IULN)
- AST(SGOT)/ALT(SGPT) < 3.0 x IULN
- Creatinine < 1.5 x IULN OR Creatinine clearance > 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
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Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
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Ability to understand and willingness to sign an IRB approved written informed consent document.
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English speaker.
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Financial coverage for proton therapy.
Exclusion Criteria:
- Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone.
- Previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of the start of treatment.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Arm 1: Resectable (proton beam therapy)
|
Muut nimet:
-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation
Muut nimet:
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Kokeellinen: Arm 2: Unresectable (proton beam therapy)
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Muut nimet:
-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
The MDASI-Plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory. 21 questions ask the patient about the severity of their symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions ask the patient about how their symptoms interfered with their life with answers ranging from 0=did not interfere to 10=interfered completely. The higher the score the more severe symptom experience the patient experienced. |
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
The EQ-5D is a standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities. The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state. Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state. The higher the score the better health a patient experienced. |
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
The 19-item MOS Social Support Survey was designed for use with patients with chronic diseases and measures how often different kinds of support are available, if needed. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed to a 0-100 scale with higher scores indicating a greater availability of social support. |
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
The CES-D questionnaire is a 20-item measure which evaluates depressive symptoms. This trial will make use of the validated 4-item screening version in order to reduce participant burden. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. |
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The MDASI-Plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory. 21 questions ask the patient about the severity of their symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions ask the patient about how their symptoms interfered with their life with answers ranging from 0=did not interfere to 10=interfered completely. The higher the score the more severe symptom experience the patient experienced. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The EQ-5D is a standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities. The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state. Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state. The higher the score the better health a patient experienced. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The 19-item MOS Social Support Survey was designed for use with patients with chronic diseases and measures how often different kinds of support are available, if needed. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed to a 0-100 scale with higher scores indicating a greater availability of social support. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The CES-D questionnaire is a 20-item measure which evaluates depressive symptoms. This trial will make use of the validated 4-item screening version in order to reduce participant burden. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Physician-reported Toxicity of PBT for Esophageal Cancer
Aikaikkuna: Through 6 months following chemoradiation (estimated to be 9 months)
|
Number of participants with grade 3 or higher specific cardiac, metabolism/nutrition, gastrointestinal, respiratory/thoracic/mediastinal, and skin/subcutaneous toxicity using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 related to PBT |
Through 6 months following chemoradiation (estimated to be 9 months)
|
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Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life. MCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65. |
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life. PCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55. |
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life. PCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life. MCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-3. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-2. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-2. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-6. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-6. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
|
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score
Aikaikkuna: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life. The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5. |
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
PBT: n yleinen eloonjääminen (OS) potilaille, joilla on resektoitava verrattuna tutkittavissa oleva ruokatorven
Aikaikkuna: 5 vuotta kemoradioinnin jälkeen (arvioidaan olevan 5 vuotta ja 3 kuukautta)
|
5 vuotta kemoradioinnin jälkeen (arvioidaan olevan 5 vuotta ja 3 kuukautta)
|
|
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Progression-free Survival (PFS) of Proton Beam Therapy (PBT) for Patients With Resectable
Aikaikkuna: 5 years following chemoradiation (estimated to be 5 years and 3 months)
|
-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. |
5 years following chemoradiation (estimated to be 5 years and 3 months)
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Gregory Vlacich, M.D., Ph.D., Washington University School of Medicine
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Ruoansulatuskanavan sairaudet
- Pään ja kaulan kasvaimet
- Ruokatorven sairaudet
- Ruokatorven kasvaimet
- Terveyspalveluiden hallinto
- Terveydenhuollon laatu, saatavuus ja arviointi
- Tutkintatekniikat
- Epidemiologiset menetelmät
- Terapeuttiset lääkkeet
- Tiedonkeruu
- Terveydenhuollon arviointimekanismit
- Terveydenhuollon laatu
- Kansanterveys
- Ympäristö ja kansanterveys
- Terveydenhuollon taloustiede ja organisaatiot
- Sädehoito
- Tuloksen arviointi, terveydenhuolto
- Tulos ja prosessien arviointi, terveydenhuolto
- Tutkimukset ja kyselylomakkeet
- Terveydenhuollon suunnittelu
- Raskas ionisäteily
- Terveydenhuollon tutkimukset
- Terveyspalveluiden tutkimus
- Potilaan tulosten arviointi
- Protoniterapia
- Potilas ilmoitti tulostoimenpiteistä
Muut tutkimustunnusnumerot
- 201803092
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