NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer
Recruiting
Phase 1
Interventional Study
Cervical Esophagus Adenocarcinoma
Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Gastroesophageal Junction Adenocarcinoma
Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
Thoracic Esophagus Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Other
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About This Trial
The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction
* Adenocarcinoma of the esophagus stages II-III allowed
* Medically able to receive chemoradiation. Following chemotherapy regimens are allowed:
* Oxaliplatin and fluorouracil (5…
Contacts
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