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NCT01333033 · ClinicalTrials.gov registry record · Phase 2
PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy
A Phase 2 study of Esophageal Cancer and Adenocarcinoma of the Gastroesophageal Junction, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 257
- Enrollment target
- 20
- Study locations
NCT01333033: Completed Phase 2 study of Esophageal Cancer and Adenocarcinoma of the Gastroesophageal Junction, sponsored by Alliance for Clinical Trials in Oncology.
NCT01333033 is a Phase 2 study of Esophageal Cancer and Adenocarcinoma of the Gastroesophageal Junction that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 257 participants, below the 497-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01333033, a Phase 2 study of Esophageal Cancer and Adenocarcinoma of the Gastroesophageal Junction, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 257 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.
Primary Outcome
The primary endpoint of this study is the percentage of PET/CT non-responders within each induction treatment group reporting a pCR. A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Fluorouracil
- DRUG Oxaliplatin
- DRUG Paclitaxel
- DRUG Leucovorin Calcium
Study Locations (20)
Hawaii
- OnCare Hawaii, Incorporated - Lusitana - Honolulu
- Queen's Cancer Institute at Queen's Medical Center - Honolulu
- Straub Clinic and Hospital, Incorporated - Honolulu
- OnCare Hawaii, Incorporated - Kuakini - Honolulu
- Kuakini Medical Center - Honolulu
- Kapiolani Medical Center for Women and Children - Honolulu
- Castle Medical Center - Kailua
- Kauai Medical Clinic - Lihue
- Kapiolani Medical Center at Pali Momi - ‘Aiea
- Oncare Hawaii, Incorporated - Pali Momi - ‘Aiea
California
- Camino Medical Group - Treatment Center - Mountain View
- Palo Alto Medical Foundation - Palo Alto
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Illinois
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University - Chicago
- John H. Stroger, Jr. Hospital of Cook County - Chicago
- University of Chicago Cancer Research Center - Chicago
Delaware
- Tunnell Cancer Center at Beebe Medical Center - Lewes
- CCOP - Christiana Care Health Services - Newark
Connecticut
- Yale Cancer Center - New Haven
District of Columbia
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 257 participants |
| Start Date | 2011-07 |
| Est. Completion | 2023-04-01 |
| Phase | Phase 2 |
What the finished NCT01333033 record still lists
NCT01333033 is an interventional study that assigns participants to a tested intervention. The registered 257 participants enrollment target is mid-sized for trials with a published cap, below the 497-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Esophageal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01333033 names 20 study sites across 6 states, led by Hawaii, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01333033 about?
NCT01333033 is a clinical study titled "PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy". RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.
What is the current status of trial NCT01333033?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 257 participants. The study started on 2011-07. Estimated completion is 2023-04-01.
What conditions does trial NCT01333033 study?
This clinical trial studies the following conditions: Esophageal Cancer, Adenocarcinoma of the Gastroesophageal Junction.
What interventions are being tested in trial NCT01333033?
The interventions under investigation include: Carboplatin (DRUG), Fluorouracil (DRUG), Oxaliplatin (DRUG), Paclitaxel (DRUG), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT01333033?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01333033 being conducted?
This trial has 20 study locations across California, Connecticut, Delaware, District of Columbia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01333033's enrollment target sits among peer trials
257 30th of 123 higher than 93 of 123 other Esophageal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal 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.
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