NCT03223662

Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy

Terminated Phase 2 Results posted Last updated 30 October 2018

What this trial tests

Phase 2 trial testing Chemoradiotherapy in Esophageal Cancer in 2 participants. Terminated before completion.

Timeline

31 October 2017

Primary endpoint
27 July 2018

27 July 2018

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	31 October 2017
Primary completion	27 July 2018
Estimated completion	27 July 2018
Sites	1 location across United States

Drugs / interventions tested

• Chemoradiotherapy — full drug profile →
• Esophagectomy

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →
• Esophageal Adenocarcinoma — all drugs for Esophageal Adenocarcinoma →
• Esophageal Squamous Cell Cancer — all drugs for Esophageal Squamous Cell Cancer →
• Esophageal Neoplasms — all drugs for Esophageal Neoplasms →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 99, any sex, with Esophageal Cancer or Esophageal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

The number of patients with esophageal cancer keeps rising. For many patients, a combination of surgery, chemotherapy, and radiation is necessary to completely treat the disease. Usually, patients receive chemotherapy and radiation at the same time followed by surgery to remove the part of the esophagus with the tumor (Neoadjuvant chemoradiotherapy (nCRT)). Researchers want to learn how to make this treatment more effective.

Objective:

To see if biopsies before treatment can show which patients will do the best with a combination of chemotherapy, radiation, and surgery.

Eligibility:

Adults at least 18 years old with esophageal adenocarcinoma or squamous cell carcinoma who should be treated with chemotherapy, radiation, and surgery.

Design:

Patients will undergo standard testing that is routine for all patients with this disease. These tests include:

Medical history

Physical exam with activity and nutritional assessment

Standard lab tests

Imaging studies including a computerized axial tomography (CAT) scan and positron-emission tomography (PET) scan

Breathing test into a machine to measure size and function of lungs.

Biopsy for a small sample of tumor is removed by esophagogastroduodenoscopy (EGD): A tube inserted into the mouth under anesthesia

Endoscopic ultrasound is performed in some but not all patients.

Patients will have nCRT at the clinic or with their local doctor.

In 6 -12 weeks after nCRT, patients will undergo surgery with:

1. A robotically-assisted, minimally-invasive esophagectomy
2. Or, a traditional, open approach.

After surgery, patients are usually in the hospital for 2 weeks and have a feeding tube for at least 2 weeks and potentially longer until they are eating enough to not lose weight.

Patients will return for follow-up visits with labs and CAT scans every 6 months for the first two years then every year afterwards.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Innovative Technologies Changing Cancer Treatment.
   Charmsaz S, Prencipe M, Kiely M, Pidgeon GP, et al · · 2018 · cited 19× · PMID 29921753 · DOI 10.3390/cancers10060208
2. Metabolomic and BH3 profiling of esophageal cancers: novel assessment methods for precision therapy.
   Taylor Ripley R, Surman DR, Diggs LP, Trepel JB, et al · · 2018 · cited 6× · PMID 29933761 · DOI 10.1186/s12876-018-0823-x
3. Mitochondria dysfunction in circulating tumor cells.
   Agnoletto C, Volinia S. · · 2022 · cited 3× · PMID 35992829 · DOI 10.3389/fonc.2022.947479