The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas

Study Purpose

The purpose of this study was to determine whether radiotherapy combined with Temozolomide is more effective than radiotherapy alone in the treatment of patients with refractory pituitary adenomas. The Basic treatment was Radiotherapy over a period of six weeks, for a total dose of 54 Gy. The150 participants were randomized to use either radiotherapy plus 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), or radiotherapy plus placebo for 6 weeks. After a 4-week break, followed by six cycles of placebo or adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle). The primary end point was Objective Response rate, the second end point was PFS. Greater response was anticipated in patients treated with Temozolomide+ radiotherapy than radiotherapy alone.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Minimum Age: 18 Years Maximum Age: 80 Years 1. Age ≥18 years, regardless of gender; 2. Meet the diagnostic criteria for refractory pituitary tumors; 1. The tumor showed invasive growth on imaging and rapid growth, Ki-67 labeling index ≥3%; 2. The tumor recurred within a short period of time (< 6months) after total resection; 3. The tumor continues to grow after surgery and medical therapy; 4. Systemic examination showed no metastases in the cranial canal or other systems throughout the body. 3. Clinicopathological diagnosis of pituitary adenoma, and pathological tissue (wax or frozen tissue) can be obtained; 4. Expected survival time ≥ 6 months; 5. KPS score ≥70 points; 6. 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: 1. Subjects participated in clinical studies of other drugs or medical devices within 3 months before screening. 2. Known to be allergic to temozolomide capsules; 3. Have been diagnosed with pituitary carcinoma or have other malignant tumors; 4. Have received radiation therapy for Sella region; 5. 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: 1. 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; 2. Severe active infections, 3. Uncontrollable diabetes, hypertension / hypotension, cerebrovascular disease, gastric ulcer, respiratory disease, active autoimmune disease, etc .; 4. History of any other diseases that the researcher judges to be unsuitable for the trial, etc .; 6. For hepatic and renal insufficiency, hematological indicators: total bilirubin> 1.5 × ULN, ALT, AST> 2.5 × ULN; serum creatinine> 2 × ULN; 7. 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; 8. Hepatitis B surface antigen, anti-HCV, anti-HIV or syphilis antibody positive; 9. Those who need to take valproic acid and drugs that can cause bone marrow depression during the application or research period; 10. pregnant or lactating women or those planning to become pregnant; 11. People with history of difficulty in drawing blood; 12. People with a history of bleeding disorders; 13. Subjects had a history of drug use or smoking and alcohol abuse within 6 months before enrollment; 14. Researchers do not consider it appropriate to participate in the trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04244708
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Peking Union Medical College Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

renzhi Wang, Dr.
Principal Investigator Affiliation pumch
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pituitary Adenomas
Additional Details

The purpose of this study was to determine whether radiotherapy combined with Temozolomide is more effective than radiotherapy alone in the treatment of patients with refractory pituitary adenomas. The Basic treatment was Radiotherapy, which is consisted of fractionated focal irradiation 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. The150 participants were randomized to use either radiotherapy plus 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), or radiotherapy plus placebo for 6 weeks. After a 4-week break, patients were then to receive up to six cycles of adjuvant temozolomide or placebo according to the standard 5-day schedule every 28 days. The dose was 150 mg per square meter for the first cycle and was increased to 200 mg per square meter beginning with the second cycle, so long as there were no hematologic toxic effects followed by six cycles of placebo or adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle). The primary end point was Objective Response rate, the second end point was PFS. Greater response was anticipated in patients treated with Temozolomide+ radiotherapy than radiotherapy alone.

Arms & Interventions

Arms

Experimental: 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.

Placebo Comparator: Radiotherapy plus placebo

Radiotherapy treatment alone undergoing fractionated radiotherapy, total 54 Gy, 2GyX27, received placebo.

Interventions

Drug: - Radiotherapy plus 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).

Other: - Radiotherapy plus 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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Renzhi Wang, Dr.

wangrz@126.com

86+18611964099

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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