Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03213002 · ClinicalTrials.gov registry record · Phase 1
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
A Phase 1 study of Cancer and Glioblastoma, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT03213002: Recruiting Phase 1 study of Cancer and Glioblastoma, sponsored by Northwell Health.
NCT03213002 is a Phase 1 study of Cancer and Glioblastoma that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 67 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03213002, a Phase 1 study of Cancer and Glioblastoma, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.
Primary Outcome
PFS will be estimated by calculating the proportion of patients who are alive at 6 months from treatment commencement and are progression-free.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Temozolomide
Study Locations (1)
New York
- Lenox Hill Brain Tumor Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2017-06-13 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT03213002 shows while recruiting
NCT03213002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower).
The record links to 9 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which Capecitabine is the first listed.
NCT03213002 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03213002 about?
NCT03213002 is a clinical study titled "Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM". The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherap...
What is the current status of trial NCT03213002?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2017-06-13. Estimated completion is 2027-06.
What conditions does trial NCT03213002 study?
This clinical trial studies the following conditions: Cancer, Glioblastoma, Brain Tumor, Brain Cancer, Brain Tumor Adult.
What interventions are being tested in trial NCT03213002?
The interventions under investigation include: Capecitabine (DRUG), Temozolomide (DRUG).
Who is sponsoring clinical trial NCT03213002?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03213002 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03213002's enrollment target sits among peer trials
67 385th of 615 higher than 231 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
RECRUITING · Phase 1
-
A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
RECRUITING · Phase 1
-
A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Impact of Daily Oral Cannabis Doses in Patients With Cancer
RECRUITING · Phase 1
-
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04115163 · 67 participants · Phase 2
Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
- NCT04315324 · 67 participants · Phase 1
Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)
- NCT04532424 · 67 participants · NA
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
- NCT05003986 · 67 participants · Phase 2
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI