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NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer

ConditionsCervical Esophagus AdenocarcinomaClinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Gastroesophageal Junction AdenocarcinomaPathologic Stage II Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage III Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8Thoracic Esophagus Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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 cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction

Adenocarcinoma of the esophagus stages II-III allowed

Oxaliplatin and fluorouracil (5-FU) or capecitabine

Docetaxel and/or 5-FU or paclitaxel

Disqualifiers

Prior radiation or any therapy for the treatment of esophageal cancer

Prior surgical resection of esophageal tumor

Esophageal cancer with radiographic evidence of metastases at screening

Esophageal fistula

Trial design

Design model

Single group

Treatments tested in this trial

  • Capecitabine

    Drug

    Not applicable to this study

  • Carboplatin

    Drug

    Not applicable to this study

  • Docetaxel

    Drug

    Not applicable to this study

  • Fluorouracil

    Drug

    Not applicable to this study

  • Hafnium Oxide-containing Nanoparticles NBTXR3

    Other intervention

    Given IT or IN

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo IMRT

  • Leucovorin

    Drug

    Not applicable to this study

  • Oxaliplatin

    Drug

    Not applicable to this study

  • Paclitaxel

    Drug

    Not applicable to this study

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Treatment (NBTXR3, IMRT, chemotherapy)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicities (DLTs)

Will be coded and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria. Descriptive summary tables will be produced, providing the DLTs by initial planned dose level of NBTXR3, initial planned volume of NBTXR3 to be injected, the injected volume, the radiation therapy dose given and the details of the concurrent chemotherapy given.

Time frame
Up to end of treatment visit (day 85)
2

Maximum tolerated dose and recommended phase 2 dose (RP2D)

The Bayesian Optimal Interval design, with accelerated titration, will be used to identify RP2D.

Time frame
Up to end of treatment visit (day 85)

Secondary outcomes

1

Incidence of NBTXR3/radiation therapy related late onset toxicities

Will be defined as any grade \>= 3 adverse event.

Time frame
From end of treatment visit (day 85) until end of study (1 year)
2

Feasibility of NBTXR3 injection in the esophageal tumor and involved regional lymph nodes

The feasibility features of NBTXR3 local administration by intratumoral injection will be presented relative to the initial planned volume level in every cohort.

Time frame
Up to 1 year
3

Objective response rate

Will be defined as the rate of complete or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, in target and non-target lesions.

Time frame
Up to 1 year
4

Major pathological response rate

Will be assessed by the Modified Ryan Scheme for Tumor Regression Score.

Time frame
Up to 1 year

Other outcomes

1

Time-course dependent presence of hafnium in blood and urine following NBTXR3 intratumoral/intranodal injection

Time frame
Up to 4 hrs post NBTXR3 injection
2

Disease control rate

Will be defined as the proportion of patients without progression (local or distant) 6-months post NBTXR3 injection.

Time frame
At 6 months post NBTXR3
3

R-status

Will be assessed macroscopically by surgeon.

Time frame
Up to 1 year
4

Pathological response rate

Will be assessed by the Modified Ryan Scheme for Tumor Regression Score.

Time frame
Up to 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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