Neuroendocrine TumorsPhase 2NCT03279601
Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor
A Phase 2 study testing Capecitabine, Dacarbazine and Capecitabine, Temozolomide in people with Neuroendocrine Tumors, run by Peking University at 1 site in China.
Trial summary
The study will be conducted to compare the safety and efficacy of Capecitabine Combined With Dacarbazine(CAPDTIC) and Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.In this prospective randomized phase II study, the investigators aim… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Capecitabine, Dacarbazine and Capecitabine, Temozolomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Sep 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sign written informed consent form
- age ≥ 18 years
- pathologically confirmed well-differentiated neuroendocrine tumor;
- No prior antitumor treatment of capecitabine, dacarbazine or temozolomide. For recurrent patients after radical surgery, adjuvant chemotherapy should not include capecitabine, dacarbazine or temozolomide, and the last date should beyond 6 months prior to randomization;
- At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
- Screening laboratory values must meet the following criteria (within past 7 days): hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN;
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- KPS ≥ 70;
- Predicted survival >=3 months;
- Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
- Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
Who cannot join
- Hypersensitivity to capecitabine, dacarbazine or temozolomide;
- Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
- Received surgery within past 4 weeks, or have not recovered from surgery;
- Severe diarrhea;
- Concurrent severe infection；
- Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including severe liver disease (active hepatitis, cirrhosis), uncontrolled diabetes or hypertension, or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
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- Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；
- Meningeal carcinomatosis;
- Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
- Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
- Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
- History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible；
- Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；
- Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, Professor, 010-88196561, Linshenpku@163.com
Shen Lin, professor
About this study
Official title: A Randomized, Controlled Phase II Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor
The study will be conducted to compare the safety and efficacy of Capecitabine Combined With Dacarbazine(CAPDTIC) and Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.In this prospective randomized phase II study, the investigators aim to compare the survival benefit as well as the safety forCapecitabine Combined With Dacarbazine(CAPDTIC) versus Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Capecitabine, Dacarbazine, Capecitabine, Temozolomide
- Keywords
- chemotherapy, OS, ORR, PFS, safety
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine, DacarbazineDrug
Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W
Capecitabine, TemozolomideDrug
Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o. bid d10-14 q4W,
| Study group | Role | What they receive |
|---|---|---|
| A: Capecitabine Combined With Dacarbazine(CAPDTIC) | Experimental | patients in arm A will receive chemotherapy of CAPDTIC regimen: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W Receives: Drug: Capecitabine, Dacarbazine |
| B: Capecitabine Combined Temozolomide(CAPTEM) | Experimental | patients in arm B will receive chemotherapy of CAPDTEM regimen: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o.d10-14 q4W Receives: Drug: Capecitabine, Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (3)
Progression-free survival
Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause
Measured: baseline, every 8 weeks up to 1 year after last patient first treatment
Overall survival
Overall survival is defined as the time from date of start of treatment to date of death due to any cause
Measured: baseline, every 8 weeks up to 1 year after last patient first treatment
Incidence of Treatment-Emergent Adverse Events （Safety and Tolerability）
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279601
- Sponsor's protocol ID
- CAPDTIC vs. CAPTEM
- Status last verified
- Sep 2017
- First submitted
- 10 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Phase II Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor
- ClinicalTrials.gov ID
- NCT03279601
- Acronym / sponsor ID
- CAPDTIC vs. CAPTEM
- Conditions
- Neuroendocrine Tumors
- Keywords
- chemotherapy, OS, ORR, PFS, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 12 Sep 2017 (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 study will be conducted to compare the safety and efficacy of Capecitabine Combined With Dacarbazine(CAPDTIC) and Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.In this prospective randomized phase II study, the investigators aim to compare the survival benefit as well as the safety forCapecitabine Combined With Dacarbazine(CAPDTIC) versus Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Capecitabine Combined With Dacarbazine(CAPDTIC) | Experimental | Drug: Capecitabine, Dacarbazinepatients in arm A will receive chemotherapy of CAPDTIC regimen: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W |
| B: Capecitabine Combined Temozolomide(CAPTEM) | Experimental | Drug: Capecitabine, Temozolomidepatients in arm B will receive chemotherapy of CAPDTEM regimen: Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o.d10-14 q4W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- sign written informed consent form
- age ≥ 18 years
- pathologically confirmed well-differentiated neuroendocrine tumor;
- No prior antitumor treatment of capecitabine, dacarbazine or temozolomide. For recurrent patients after radical surgery, adjuvant chemotherapy should not include capecitabine, dacarbazine or temozolomide, and the last date should beyond 6 months prior to randomization;
- At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
Key exclusion criteria (14 listed)
- Hypersensitivity to capecitabine, dacarbazine or temozolomide;
- Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
- Received surgery within past 4 weeks, or have not recovered from surgery;
- Severe diarrhea;
- Concurrent severe infection；
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 |
|---|---|---|
| Capecitabine, DacarbazineCapecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W | Drug | A: Capecitabine Combined With Dacarbazine(CAPDTIC) |
| Capecitabine, TemozolomideCapecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o. bid d10-14 q4W, | Drug | B: Capecitabine Combined Temozolomide(CAPTEM) |
Primary outcome
Overall response rate (ORR)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1
3 secondary outcomes
Progression-free survival
Time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
Overall survival
Time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
Incidence of Treatment-Emergent Adverse Events （Safety and Tolerability）
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine, Dacarbazine and Capecitabine, Temozolomide in people with Neuroendocrine Tumors, run by Peking University at 1 site in China.
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 10 inclusion and 14 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 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Lin Shen (86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2017.