- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04244708
The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas
Radiotherapy Plus Concomitant Temozolomide for Refractory Pituitary Adenomas,A Randomized,Double-blind, Placebo-controlled Phase II Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Renzhi Wang, Dr.
- Telefonnummer: 86+18611964099
- E-mail: wangrz@126.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Minimum Age: 18 Years Maximum Age: 80 Years
- Age ≥18 years, regardless of gender;
Meet the diagnostic criteria for refractory pituitary tumors;
- The tumor showed invasive growth on imaging and rapid growth, Ki-67 labeling index ≥3%;
- The tumor recurred within a short period of time (< 6months) after total resection;
- The tumor continues to grow after surgery and medical therapy;
- Systemic examination showed no metastases in the cranial canal or other systems throughout the body.
- Clinicopathological diagnosis of pituitary adenoma, and pathological tissue (wax or frozen tissue) can be obtained;
- Expected survival time ≥ 6 months;
- KPS score ≥70 points;
- Subjects who were able to read, understand, and sign written informed consent prior to participating in the study and were willing to comply with protocol requirements.
Exclusion Criteria:
Participants cannot participate in this study if they meet any of the following conditions:
- Subjects participated in clinical studies of other drugs or medical devices within 3 months before screening.
- Known to be allergic to temozolomide capsules;
- Have been diagnosed with pituitary carcinoma or have other malignant tumors;
- Have received radiation therapy for Sella region;
Those with severe acute and chronic diseases in various systems, whose conditions have not been effectively controlled, and whose conditions are unstable, including but not limited to:
- Patients with cardiac insufficiency (NYHA cardiac function grade ≥ 2), patients with severe heart disease such as cardiomyopathy, coronary heart disease, severe arrhythmia, etc. that are not effectively controlled;
- Severe active infections,
- Uncontrollable diabetes, hypertension / hypotension, cerebrovascular disease, gastric ulcer, respiratory disease, active autoimmune disease, etc .;
- History of any other diseases that the researcher judges to be unsuitable for the trial, etc .;
- For hepatic and renal insufficiency, hematological indicators: total bilirubin> 1.5 × ULN, ALT, AST> 2.5 × ULN; serum creatinine> 2 × ULN;
- Those with a neutrophil count of less than 1.5 × 109 / L, or a platelet count of less than 100 × 109 / L, or an HGB of less than 90g / L;
- Hepatitis B surface antigen, anti-HCV, anti-HIV or syphilis antibody positive;
- Those who need to take valproic acid and drugs that can cause bone marrow depression during the application or research period;
- pregnant or lactating women or those planning to become pregnant;
- People with history of difficulty in drawing blood;
- People with a history of bleeding disorders;
- Subjects had a history of drug use or smoking and alcohol abuse within 6 months before enrollment;
- Researchers do not consider it appropriate to participate in the trial.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Radiotherapy plus temozolomide
Undergoing fractionated radiotherapy at a dose of 2 Gy per fraction given once daily five days per week for a total dose of 54 Gy, plus continuous daily temozolomide (75 mg per square meter of body-surface area per day), followed by six cycles of adjuvant temozolomide.
|
undergoing fractionated radiotherapy at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks, for a total dose of 54 Gy, plus continuous daily temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).
|
Placebo komparator: Radiotherapy plus placebo
Radiotherapy treatment alone undergoing fractionated radiotherapy, total 54 Gy, 2GyX27, received placebo.
|
undergoing fractionated radiotherapy at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks, for a total dose of 54 Gy, plus placebo
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Tumor size
Tidsramme: Four weeks after concurrent chemoradiotherapy, patients were then to receive three cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days. At the end of Cycle 3 (each cycle is 28 days)
|
A tumor response was defned as a decrease of more than 30% of the largest tumor diameter or stable in Tumor volume
|
Four weeks after concurrent chemoradiotherapy, patients were then to receive three cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days. At the end of Cycle 3 (each cycle is 28 days)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hormonal responses
Tidsramme: Four weeks after concurrent chemoradiotherapy, patients were then to receive three cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days. At the end of Cycle 3 (each cycle is 28 days)
|
Hormonal response as a 50% or more decrease in baseline hormone levels.
|
Four weeks after concurrent chemoradiotherapy, patients were then to receive three cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days. At the end of Cycle 3 (each cycle is 28 days)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: renzhi Wang, Dr., PUMCH
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Sygdomme i det endokrine system
- Neoplasmer i endokrine kirtler
- Hypothalamus sygdomme
- Hypothalamiske neoplasmer
- Supratentoriale neoplasmer
- Neoplasmer i hjernen
- Neoplasmer i centralnervesystemet
- Neoplasmer i nervesystemet
- Adenom
- Hypofyse neoplasmer
- Hypofysesygdomme
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Temozolomid
Andre undersøgelses-id-numre
- PekingUMCH-PA-TMZ
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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