Chemotherapy for Esophageal Cancer

(TNT Esophagus Trial)

Overseen By Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must be taking: Chemoradiation, Chemotherapy

Disqualifiers: Metastatic disease, Prior therapy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding extra chemotherapy (FOLFOX, a chemotherapy regimen) after standard chemoradiation can more effectively prevent esophageal cancer from returning or spreading and may reduce the need for surgery. It targets a specific type of esophageal cancer, adenocarcinoma, affecting the thoracic region or the junction where the stomach meets the esophagus. Individuals recently diagnosed with this cancer type and suitable for standard chemoradiation may be good candidates. Participants will first undergo standard chemoradiation treatment, followed by the additional chemotherapy. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer treatment.

Is there any evidence suggesting that FOLFOX is likely to be safe for humans?

Previous studies have shown FOLFOX to be safe for treating esophageal cancer. Research indicates that patients generally tolerate this treatment well. Some studies found it safe and effective, especially for those unable to use cisplatin-based treatments. Most patients experience manageable side effects, and quality of life data suggest it is well tolerated as a supporting treatment. Although every treatment can have side effects, available evidence suggests that FOLFOX is a reasonably safe option for patients with esophageal cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about this treatment because it combines chemoradiation with the FOLFOX regimen, a powerful chemotherapy combination. Unlike standard treatments for esophageal cancer, which often involve surgery or different chemotherapy drugs, this approach uses FOLFOX after chemoradiation, potentially enhancing effectiveness. The FOLFOX regimen includes oxaliplatin, which may offer improved outcomes by working synergistically with the radiation therapy to target cancer cells more precisely. This unique approach could lead to better survival rates and a more targeted attack on the cancer, making it an exciting development in esophageal cancer treatment.

What evidence suggests that adding consolidative chemotherapy might be an effective treatment for esophageal cancer?

Research has shown that FOLFOX chemotherapy can effectively treat esophageal cancer, particularly in advanced stages. Studies have identified FOLFOX as a reliable option for esophageal cancer that has spread, often serving as a first-line treatment. One study found that FOLFOX helped shrink or eliminate tumors in 48.5% of patients, with 12% experiencing complete tumor disappearance. Considered safe, it has proven effective when used before surgery or as an alternative to treatments with cisplatin, another cancer drug. In this trial, participants will receive a standard course of chemoradiation followed by consolidative chemotherapy with the FOLFOX regimen. While it might not improve survival compared to some other treatments, it remains a strong option for controlling the disease. ^{1 2 6 7 8}

Who Is on the Research Team?

Manisha Palta, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for adults with a new diagnosis of adenocarcinoma in the thoracic esophagus or gastroesophageal junction (stage II-IVA, but not T4b), who have no signs of cancer spread and are healthy enough for chemotherapy and radiation. Participants must be able to give consent and have good organ function.

Inclusion Criteria

I am able to understand and sign the study consent form.

I have had a full check-up within the last 21 days.

I had a recent scan showing my cancer has not spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation

Participants receive a standard course of chemoradiation

approximately 12 weeks

Consolidative Chemotherapy

Participants receive consolidative chemotherapy (FOLFOX regimen)

approximately 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• FOLFOX

Trial Overview

The study tests if adding extra chemotherapy (FOLFOX) after standard chemoradiation can better control localized esophageal cancer compared to chemoradiation alone. All participants receive initial chemo plus radiation, then some get additional FOLFOX chemo.

How Is the Trial Designed?

Group I: chemoradiation with consolidative chermotherapy Experimental Treatment 1 Intervention

Participants will receive a standard course of chemoradiation followed by consolidative chemotherapy (FOLFOX regimen at the treating physican's discretion)

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1.

physicianresources.dana-farber.org

physicianresources.dana-farber.org/news/new-targeted-treatments-emerge-for-gastric-and-esophageal-cancer

New Targeted Treatments Emerge for Gastric and ...

Patients with advanced gastric or gastric-esophageal junction cancer were enrolled in SPOTLIGHT and received zolbetuximab and FOLFOX or FOLFOX ...

2.

ruesch.georgetown.edu

ruesch.georgetown.edu/uppergi/

Patients - Upper GI Cancer

FOLFOX and CAPOX are the two primary chemotherapy regimens used in the first line setting of stage 4 gastric and esophageal cancer treatment. FOLFOX and ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11889194/

The efficacy and safety of FOLFOX therapy for advanced ...

First-line FOLFOX treatment is suitable for patients with advanced ESCC. However, FOLFOX has shown limited efficacy as a later-line treatment.

4.

nature.com

nature.com/articles/s41598-025-92657-7

The efficacy and safety of FOLFOX therapy for advanced ...

The FOLFOX regimen consisted of 85 mg/m2 oxaliplatin (L-OHP), 200 mg/m2 leucovorin, and a bolus injection of 5-fluorouracil 400 mg/m2 ...

5.

tcr.amegroups.org

tcr.amegroups.org/article/view/15963/html

the making or breaking of a backbone - Dhanarajan

FOLFOX remains a reliable chemotherapy option for treatment of metastatic esophageal and GEJ cancer. Is it the only backbone that should be ...

6.

gastroenterologyadvisor.com

gastroenterologyadvisor.com/news/preoperative-folfox-therapy-safe-efficacious-for-esophageal-cancer/

Preoperative FOLFOX Therapy Safe, Efficacious for ...

Preoperative FOLFOX therapy was efficacious for patients with esophageal cancer who could not receive cisplatin-containing treatment.

7.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.3_suppl.280

First-line FOLFOX therapy for advanced esophageal ...

Conclusions: First-line FOLFOX showed an acceptable safety profile and the prespecified statistical efficacy target was achieved. FOLFOX might ...

8.

withpower.com

withpower.com/trial/phase-3-esophageal-neoplasms-5-2017-8af8b

Induction Chemotherapy for Esophageal Cancer

Overall survival at 3 years was 19.9% (95% CI 10.8–31.0) in the FOLFOX group and 26.9% (95% CI 16.9–37.8) in the cisplatin-fluorouracil group. ... Health ...