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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

Tracking Information
First Submitted Date  ICMJE December 30, 2019
First Posted Date  ICMJE January 28, 2020
Last Update Posted Date January 28, 2020
Estimated Study Start Date  ICMJE February 10, 2020
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas
Official Title  ICMJE Radiotherapy Plus Concomitant Temozolomide for Refractory Pituitary Adenomas,A Randomized,Double-blind, Placebo-controlled Phase II Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Pituitary Adenomas
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Radiotherapy plus temozolomide
  • Placebo Comparator: Radiotherapy plus placebo
    Radiotherapy treatment alone undergoing fractionated radiotherapy, total 54 Gy, 2GyX27, received placebo.
    Intervention: Other: Radiotherapy plus placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Renzhi Wang, Dr. 86+18611964099 wangrz@126.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04244708
Other Study ID Numbers  ICMJE PekingUMCH-PA-TMZ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: renzhi Wang, Dr. pumch
PRS Account Peking Union Medical College Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP