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The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas

Primary Purpose

Pituitary Adenomas

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Radiotherapy plus temozolomide
Radiotherapy plus placebo
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Adenomas focused on measuring Temozolomide; radiotherapy; refractory pituitary adenomas

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Radiotherapy plus temozolomide

    Radiotherapy plus placebo

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Tumor size
    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

    Hormonal responses
    Hormonal response as a 50% or more decrease in baseline hormone levels.

    Full Information

    First Posted
    December 30, 2019
    Last Updated
    January 27, 2020
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04244708
    Brief Title
    The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas
    Official Title
    Radiotherapy Plus Concomitant Temozolomide for Refractory Pituitary Adenomas,A Randomized,Double-blind, Placebo-controlled Phase II Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 10, 2020 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pituitary Adenomas
    Keywords
    Temozolomide; radiotherapy; refractory pituitary adenomas

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiotherapy plus temozolomide
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Radiotherapy plus placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Radiotherapy treatment alone undergoing fractionated radiotherapy, total 54 Gy, 2GyX27, received placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    Radiotherapy plus temozolomide
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Radiotherapy plus placebo
    Intervention Description
    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 Measure Information:
    Title
    Tumor size
    Description
    A tumor response was defned as a decrease of more than 30% of the largest tumor diameter or stable in Tumor volume
    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)
    Secondary Outcome Measure Information:
    Title
    Hormonal responses
    Description
    Hormonal response as a 50% or more decrease in baseline hormone levels.
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Renzhi Wang, Dr.
    Phone
    86+18611964099
    Email
    wangrz@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    renzhi Wang, Dr.
    Organizational Affiliation
    pumch
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas

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