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The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04244708
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pituitary Adenomas Drug: Radiotherapy plus temozolomide Other: Radiotherapy plus placebo Phase 2 Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Radiotherapy Plus Concomitant Temozolomide for Refractory Pituitary Adenomas,A Randomized,Double-blind, Placebo-controlled Phase II Trial
Estimated Study Start Date : February 10, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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).

Placebo Comparator: Radiotherapy plus placebo
Radiotherapy treatment alone undergoing fractionated radiotherapy, total 54 Gy, 2GyX27, received placebo.
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




Primary Outcome Measures :
  1. Tumor size [ Time Frame: 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


Secondary Outcome Measures :
  1. Hormonal responses [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04244708


Contacts
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Contact: Renzhi Wang, Dr. 86+18611964099 wangrz@126.com

Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Director: renzhi Wang, Dr. pumch
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04244708    
Other Study ID Numbers: PekingUMCH-PA-TMZ
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Peking Union Medical College Hospital:
Temozolomide; radiotherapy; refractory pituitary adenomas
Additional relevant MeSH terms:
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Adenoma
Pituitary Neoplasms
Pituitary Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents