Pituitary AdenomasPhase 2/3NCT04244708
The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas
A Phase 2/3 study testing Radiotherapy plus temozolomide in people with Pituitary Adenomas, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pituitary Adenomas
- What is being tested?
- Radiotherapy plus temozolomide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2020to 1 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Radiotherapy Plus Concomitant Temozolomide for Refractory Pituitary Adenomas，A Randomized，Double-blind, Placebo-controlled Phase II Trial
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.
Read the 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.
- Conditions
- Pituitary Adenomas
- Being tested
- Radiotherapy plus temozolomide, Radiotherapy plus placebo
- Keywords
- Temozolomide; radiotherapy; refractory pituitary adenomas
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy plus temozolomideDrug
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).
Radiotherapy plus placeboOther
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 group | Role | What they receive |
|---|---|---|
| Radiotherapy plus temozolomide | Experimental | 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. Receives: Drug: Radiotherapy plus temozolomide |
| Radiotherapy plus placebo | Placebo comparator | Radiotherapy treatment alone undergoing fractionated radiotherapy, total 54 Gy, 2GyX27, received placebo. Receives: Other: Radiotherapy plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor size
A tumor response was defned as a decrease of more than 30% of the largest tumor diameter or stable in Tumor volume
Measured: 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 outcomes (1)
Hormonal responses
Hormonal response as a 50% or more decrease in baseline hormone levels.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start10 Feb 2020 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomasStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- renzhi Wang, Dr., Study director, pumch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244708
- Sponsor's protocol ID
- PekingUMCH-PA-TMZ
- Status last verified
- Jan 2020
- First submitted
- 30 Dec 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burman P, Casar-Borota O, Perez-Rivas LG, Dekkers OM. Aggressive Pituitary Tumors and Pituitary Carcinomas: From Pathology to Treatment. J Clin Endocrinol Metab. 2023 Jun 16;108(7):1585-1601. doi: 10.1210/clinem/dgad098.
PubMed 36856733
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy Plus Concomitant Temozolomide for Refractory Pituitary Adenomas，A Randomized，Double-blind, Placebo-controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT04244708
- Acronym / sponsor ID
- PekingUMCH-PA-TMZ
- Conditions
- Pituitary Adenomas
- Keywords
- Temozolomide; radiotherapy; refractory pituitary adenomas
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 Feb 2020 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy plus temozolomide | Experimental | Drug: Radiotherapy plus temozolomideUndergoing 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 plus placebo | Placebo comparator | Other: Radiotherapy plus placeboRadiotherapy treatment alone undergoing fractionated radiotherapy, total 54 Gy, 2GyX27, received placebo. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Minimum Age: 18 Years Maximum Age: 80 Years
- Age ≥18 years, regardless of gender;
- Meet the diagnostic criteria for refractory pituitary tumors;
- Clinicopathological diagnosis of pituitary adenoma, and pathological tissue (wax or frozen tissue) can be obtained;
- Expected survival time ≥ 6 months;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy plus temozolomideundergoing 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). | Drug | Radiotherapy plus temozolomide |
| Radiotherapy plus placeboundergoing 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 | Other | Radiotherapy plus placebo |
Primary outcome
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
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Derived from this study: PubMed 36856733Burman P, Casar-Borota O, Perez-Rivas LG, Dekkers OM. Aggressive Pituitary Tumors and Pituitary Carcinomas: From Pathology to Treatment. J Clin Endocrinol Metab. 2023 Jun 16;108(7):1585-1601. doi: 10.1210/clinem/dgad098.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
renzhi Wang, Dr. study director
pumch
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radiotherapy plus temozolomide in people with Pituitary Adenomas, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renzhi Wang, Dr. (86+18611964099, wangrz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04244708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.