Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer

NCT03161522 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2016-0972NCI-2018-01202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well chemotherapy with or without radiation or surgery works in treating participants with esophageal or gastric cancer that has spread to less than 3 places in the body (oligometastatic). Drugs used in chemotherapy, such as fluorouracil and capecitabine, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Surgery, such as complete surgical resection, may stop the spread of tumor cells by surgically removing organs or tumors. Giving chemotherapy with radiation or surgery may work better than chemotherapy alone in treating participants with oligometastatic esophageal or gastric cancer.

Conditions

Gastric Adenocarcinoma; Oligometastasis; Stage IV Esophageal Adenocarcinoma AJCC v7; Stage IV Esophageal Cancer AJCC v7; Stage IV Gastric Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.

  Up to 6 years

Secondary Outcomes (4)

• Local progression-free survival (PFS)

  Up to 6 years

• Distant PFS

  Up to 6 years

• Incidence of adverse events

  Up to 6 years

• Time to local or regional disease recurrence

  Up to 6 years

Other Outcomes (2)

• Time to local disease recurrence

  Up to 6 years

• Time to disease progression

  Up to 6 years

Study Arms (2)

Group I (maintenance chemotherapy)

EXPERIMENTAL

Participants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity.

Drug: Capecitabine; Drug: Chemotherapy; Drug: Fluorouracil

Group II (local therapy)

EXPERIMENTAL

Participants receive fluorouracil and capecitabine and undergo RT per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Participants may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician.

Drug: Capecitabine; Drug: Chemotherapy; Procedure: Conventional Surgery; Drug: Fluorouracil; Radiation: Radiation Therapy

Interventions

Capecitabine DRUG

Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.

Also known as: Ro 09-1978/000, Xeloda

Group I (maintenance chemotherapy); Group II (local therapy)

Chemotherapy DRUG

Receive induction chemotherapy

Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

Group I (maintenance chemotherapy); Group II (local therapy)

Conventional Surgery PROCEDURE

Undergo surgery

Group II (local therapy)

Fluorouracil DRUG

Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.

Also known as: 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Group I (maintenance chemotherapy); Group II (local therapy)

Radiation Therapy RADIATION

Undergo RT

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Group II (local therapy)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology
• The patient is staged with EGD and PET/CT scan.
• The patient has three or less observable metastatic lesions. Patients may have three or less radiographically visible metastatic lesions at diagnosis or if have regressed to three or less metastatic lesions after induction chemotherapy at time of randomization. The patient must have pathologic confirmation and or radiologically visible disease. For esophageal tumors, the maximal dimension of the primary tumor may not provide reproducible measurements for RECIST and may not be visible on CT or PET/CT at diagnosis or after induction chemotherapy. Accordingly, patients are eligible regardless of the imaging measurements of the primary tumor. Additionally, in patients with non-measurable metastases, patients are eligible if there is pathology confirming metastases from a distant site. However, biopsy of a metastatic site is not required if there are visible metastases on imaging (such as ultrasound, diagnostic CT , EUS, PET/CT).
• The patient has three or less observable metastatic lesions by diagnostic scans (CT scan, PET/CT, eEndoscopic ultrasound, MRI, or bone scan). Metastatic lesions include distant M1 lymph node group; which will be counted as one site (M1 metastatic lymph nodes to include cervical, mediastinal, gastric, retroperitoneal lymph nodes will be counted as one lesion).
• Osseous metastases or visceral metastases will each count as one metastatic site.
• Each CNS metastases will count as one metastatic site.
• Satellite lesions in the primary esophageal malignancy such as skipped esophageal primaries are not considered metastatic sites. Symptomatic metastatic sites can be treated locally prior to randomization or by palliative radiation.
• Symptomatic metastatic sites may be treated with radiation or surgery prior to enrollment.
• Patient ECOG of 0-2, with life expectancy of at least 6 months
• Patients age \>18 yrs old but \<80 yrs old and signed informed consent
• Women of child-bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after discontinuation of systemic agents.

You may not qualify if:

• Patients with prior chemotherapy or radiation therapy for their diagnosis of esophageal or gastric cancer. Patients with prior radiation therapy to same site for another diagnosis of cancer. Note: Patients may receive palliative radiation to their symptomatic sites of metastases but not definitive local therapy to esophageal or gastric primary prior to randomization. All patients may be enrolled on protocol then start systemic therapy; if they do not have evidence of disease progression at re-staging following initial therapy, they may be randomized.
• Patients with fistula documented radiographically or by EDG/EUS, EBUS.
• Patients with life expectancy less than 6 months, ECOG \>3
• Female patients who are pregnant confirmed by bHCG lab test.
• Patient has history of uncontrolled angina, congestive heart failure or recent MI within 6 months.
• Nursing females
• Patients in poor nutritional state
• Patients with:
• Severely depressed bone marrow function
• Potentially serious infections
• Known hypersensitivity to 5-fluorouracil
• Known or suspected to have a dihydropyrimidine dehydrogenase deficiency (as these patients are at a greater risk of experiencing symptoms of toxicity)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Esophageal Neoplasms; Stomach Neoplasms

Interventions

Capecitabine; Drug Therapy; Fluorouracil; dehydroftorafur; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics; Physical Phenomena

Study Officials

• Quynh-Nhu Nguyen

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quynh Nhu Nguyen, MD

CONTACT

713-563-2300; qnnguyen@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: February 19, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)