Who is sponsoring NCT01307956?

NCT01307956 is sponsored by University of Nebraska.

What drugs are being tested in NCT01307956?

Interventions in NCT01307956: Fluorouracil, Laboratory Biomarker Analysis, Leucovorin Calcium, Oxaliplatin, Panitumumab, Pharmacological Study, Radiation Therapy, Therapeutic Conventional Surgery.

What condition does NCT01307956 study?

NCT01307956 studies Adenocarcinoma of the Gastroesophageal Junction, Esophageal Adenocarcinoma, Stage IIA Esophageal Cancer, Stage IIB Esophageal Cancer.

Is NCT01307956 still recruiting?

NCT01307956 is currently terminated. Last updated 26 October 2023.

Are results published for NCT01307956?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-26 · How we verify

NCT01307956

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Panitumumab, Combination Chemotherapy, & Radiation Therapy in Esophageal or Gastroesophageal Junction Cancer

Terminated Phase 2 Results posted Last updated 26 October 2023

What this trial tests

Phase 2 trial testing Fluorouracil in Adenocarcinoma of the Gastroesophageal Junction in 11 participants. Terminated before completion.

Timeline

28 February 2011

Primary endpoint
23 December 2015

23 December 2015

Quick facts

Lead sponsor	University of Nebraska
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	28 February 2011
Primary completion	23 December 2015
Estimated completion	23 December 2015
Sites	1 location across United States

Drugs / interventions tested

Fluorouracil — full drug profile →
Laboratory Biomarker Analysis
Leucovorin Calcium
Oxaliplatin (Oxaliplatin) — full drug profile →
Panitumumab
Pharmacological Study — full drug profile →
Radiation Therapy
Therapeutic Conventional Surgery

Conditions studied

Adenocarcinoma of the Gastroesophageal Junction — all drugs for Adenocarcinoma of the Gastroesophageal Junction →
Esophageal Adenocarcinoma — all drugs for Esophageal Adenocarcinoma →
Stage IIA Esophageal Cancer — all drugs for Stage IIA Esophageal Cancer →
Stage IIB Esophageal Cancer — all drugs for Stage IIB Esophageal Cancer →

Sponsor

University of Nebraska

Who can join

19 and older, any sex, with Adenocarcinoma of the Gastroesophageal Junction or Esophageal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Complete Pathological Response (pCR) Rate Primary · Up to 8 weeks

Based on the proportion who achieve pCR based on the first 4 courses of protocol treatment. Evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate.

Group	Value	95% CI
Treatment (Panitumumab, Chemotherapy, Radiation)	3

Number of Patients Who Can Undergo Resection Secondary · 4 weeks after completion of the radiation

Restaging with repeat imaging studies will be performed. If no contraindication for surgical resection is identified, resection will be performed. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate.

Group	Value	95% CI
Treatment (Panitumumab, Chemotherapy, Radiation)	11

Progression-free Survival Secondary · Patients were followed from time of consent until the date of first documented progession or date of death from any cause, whichever came first, assessed up to 100 months.

Descriptively summarized using the method of Kaplan-Meier. Response and disease progression were assessed using RECIST criteria version 1.1

Group	Value	95% CI
Treatment (Panitumumab, Chemotherapy, Radiation)	409	119 – 2840

Overall Survival Secondary · From the first date of therapy until the date the patient dies, assessed up to 100 months

Descriptively summarized using the method of Kaplan-Meier.

Group	Value	95% CI
Treatment (Panitumumab, Chemotherapy, Radiation)	596	119 – 2840

Adverse events — posted to ClinicalTrials.gov

Time frame: Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Panitumumab, Chemotherapy, Radiation)

Serious: 10/11 (91%)

Deaths: 7/11

Serious adverse events (54 terms)

Reaction	System	Treatment (Panitumumab, Ch…
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	—
Lung infection	Infections and infestations	—
hypotension	Vascular disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Thromboembolic event	Vascular disorders	—
dehydration	Metabolism and nutrition disorders	—
Gastrointestinal disorders - Other	Gastrointestinal disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Sepsis	Infections and infestations	—
Surgical and medical procedures - Other	Surgical and medical procedures	—
Fever	General disorders	—
Anemia	Blood and lymphatic system disorders	—
Weight loss	Investigations	—
diarrhea	Gastrointestinal disorders	—
Thromboembolic event	Vascular disorders	—
pulmonary edema	Respiratory, thoracic and mediastinal disorders	—
nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
bradycardia	Cardiac disorders	—
Gastrointestinal disorders - Other	Gastrointestinal disorders	—
Gastrointestinal disorders - Other	Gastrointestinal disorders	—
Gastrointestinal disorders - Other	Gastrointestinal disorders	—
Pericarditis	Cardiac disorders	—
Chest pain - cardiac	Cardiac disorders	—

Other adverse events (51 terms — click to expand)

Reaction	System	Treatment (Panitumumab, Ch…
Hypokalemia	Metabolism and nutrition disorders	—
Anorexia	Metabolism and nutrition disorders	—
White blood cells decreased	Investigations	—
lymphocyte count decreased	Investigations	—
Neutrophil count decreased	Investigations	—
Anemia	Blood and lymphatic system disorders	—
dysphagia	Gastrointestinal disorders	—
Hypoalbuminemia	Metabolism and nutrition disorders	—
hypophosphatemia	Metabolism and nutrition disorders	—
hyperglycemia	Metabolism and nutrition disorders	—
hypoxia	Respiratory, thoracic and mediastinal disorders	—
Platelet cell count decreased	Investigations	—
Diarrhea	Gastrointestinal disorders	—
Hoarseness	Respiratory, thoracic and mediastinal disorders	—
Lung infection	Infections and infestations	—
Nausea	Gastrointestinal disorders	—
Pain	General disorders	—
Hypotension	Vascular disorders	—
hypocalcemia	Metabolism and nutrition disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
weight loss	Investigations	—
depression	Psychiatric disorders	—
mucositis - oral	Gastrointestinal disorders	—
pleural effusion	Respiratory, thoracic and mediastinal disorders	—
Acidosis	Metabolism and nutrition disorders	—
blood bilirubin increased	Investigations	—
constipation	Gastrointestinal disorders	—
Infections and infestations - Other	Infections and infestations	—
dysgeusia	Nervous system disorders	—
Febrile neutropenia	Blood and lymphatic system disorders	—
Ileus	Gastrointestinal disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Depressed level of consciousness	Nervous system disorders	—
Respiratory, thoracic and mediastinal disorders - Other	Respiratory, thoracic and mediastinal disorders	—
INR increased	Investigations	—
Skin and subcutatneous tissue disorder - Other	Skin and subcutaneous tissue disorders	—
hyponatremia	Metabolism and nutrition disorders	—
Injury, poisoning and procedural complications - Other	Gastrointestinal disorders	—
Esophageal pain	Gastrointestinal disorders	—
Aspartate aminotransferase increased	Investigations	—

Most-reported serious reactions: Hypoxia, Adult respiratory distress syndrome, Lung infection, hypotension, Dyspnea, Thromboembolic event, dehydration, Gastrointestinal disorders - Other.

Data from ClinicalTrials.gov NCT01307956 adverse events section.

Sponsor's own description

This phase II trial is studying how well giving panitumumab, combination chemotherapy, and radiation therapy together before surgery works in treating patients with advanced esophageal or gastroesophageal (GE) junction cancer. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, 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. Giving monoclonal antibody therapy together with chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Trial watch: Chemotherapy with immunogenic cell death inducers.
Vacchelli E, Galluzzi L, Fridman WH, Galon J, et al · · 2012 · cited 98× · PMID 22720239 · DOI 10.4161/onci.1.2.19026

Verify or expand the search:

Other trials of Fluorouracil

Trials testing the same drug.

NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
NCT07271355 — Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colore · Phase 3 · not yet recruiting
NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies · Phase 2 · not yet recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
NCT07456852 — Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Ca · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Adenocarcinoma of the Gastroesophageal Junction

Currently open trials in the same condition.

NCT04028167 — Induction FLOT With CROSS CRT for Esophageal Cancer · Phase 2 · active not recruiting

Other University of Nebraska trials

Trials by the same sponsor.

NCT07507006 — Feasibility Study of the Flash-Sole: A Wearable Midsole With Soft Actuators for Walking Assistance · NA · not yet recruiting
NCT07517705 — MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma · NA · not yet recruiting
NCT07506993 — Inflammation in Clear Aligners With and Without Attachments · not yet recruiting
NCT07207850 — Parents Helping Parents for Youth Vaping Cessation · NA · not yet recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01307956 (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 University of Nebraska
Last refreshed: 26 October 2023

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/NCT01307956.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing