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NCT03161522
Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
Phase 2 trial testing Capecitabine in Gastric Adenocarcinoma in 100 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 19 February 2018 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Capecitabine (capecitabine) — full drug profile →
- Chemotherapy (chemotherapy) — full drug profile →
- Conventional Surgery
- Fluorouracil — full drug profile →
- Radiation Therapy — full drug profile →
Conditions studied
- Gastric Adenocarcinoma — all drugs for Gastric Adenocarcinoma →
- Oligometastasis — all drugs for Oligometastasis →
- Stage IV Esophageal Adenocarcinoma AJCC v7 — all drugs for Stage IV Esophageal Adenocarcinoma AJCC v7 →
- Stage IV Esophageal Cancer AJCC v7 — all drugs for Stage IV Esophageal Cancer AJCC v7 →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
Adults 18 to 79, any sex, with Gastric Adenocarcinoma or Oligometastasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Outcomes of concurrent chemoradiotherapy versus chemotherapy alone for esophageal squamous cell cancer patients presenting with oligometastases.
Chen Y, Cheng X, Song H, Wu AJ, et al · · 2019 · cited 29× · PMID 31179097 · DOI 10.21037/jtd.2019.03.10 -
Survival after Multimodal Treatment Including Surgery for Metastatic Esophageal Cancer: A Systematic Review.
Bardol T, Ferre L, Aouinti S, Dupuy M, et al · · 2022 · cited 12× · PMID 36010949 · DOI 10.3390/cancers14163956 -
Oligometastatic disease in esophagogastric cancer: an update of recommendations on definition, diagnosis, and treatment.
Kroese TE, Bronzwaer SFC, van Hillegersberg R, van Rossum PSN, et al · · 2023 · cited 1× · PMID 41647727 · DOI 10.1016/j.esmogo.2023.08.008 -
The evolving concept of conversion surgery for upfront unresectable upper gastrointestinal and hepato-pancreato-biliary cancers: comprehensive review.
Perri G, Engstrand J, Wright RD, Bronzwaer SFC, et al · · 2025 · cited 1× · PMID 40631805 · DOI 10.1093/bjsopen/zraf070
Verify or expand the search:
- PubMed search for NCT03161522
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Gastric Adenocarcinoma
Currently open trials in the same condition.
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03161522 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03161522.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing