NCT00551759|TerminatedPhase 2Results

Study Stopped

The study used a two-stage design. After stage one, the study was terminated due to excess toxicity.

Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer

A Phase II Study to Measure Response Rate and Toxicity of Neo-adjuvant Chemoradiotherapy With Oxaliplatin (OX) and Infusional 5-Fluorouracil (5-FU) Plus Cetuximab Followed by Post-Operative Docetaxel and Cetuximab in Patients With Operable Adenocarcinoma of the Esophagus

Eastern Cooperative Oncology Group ClinicalTrials.gov

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3 other identifiers

CDR0000571857U10CA021115E2205

Study Type

interventional

Target

Locations

1 country

Sites

109

Timeline

RegisteredOct 2007

StartedOct 2008

CompletionFeb 2014

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving docetaxel and cetuximab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with cetuximab followed by surgery, docetaxel and cetuximab works in treating patients with esophageal cancer or gastroesophageal junction cancer.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Oct 2008

Longer than P75 for phase_2

Geographic Reach

1 country

109 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.3 years study duration

First Submitted

Initial submission to the registry

October 30, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed

11 months until next milestone

Study Start

First participant enrolled

October 2, 2008

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed

27 days until next milestone

Results Posted

Study results publicly available

February 28, 2014

Completed

Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

3 years

First QC Date

October 30, 2007

Results QC Date

January 17, 2014

Last Update Submit

June 14, 2023

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophaguschemoradiotherapyoxaliplatincetuximabdocetaxel

Outcome Measures

Primary Outcomes (1)

Proportion of Patients With Pathologic Complete Response
After neoadjuvant therapy, participants underwent surgical resection. The excised tumor was examined by a pathologist. A pathologic complete response is defined as the absence of any histopathologic evidence of tumor in the resected esophageal and nodal tissue specimen.
At time of surgery (which occurred 63 to 91 days after study entry)

Study Arms (1)

Neoadjuvant therapy, Surgery, adjuvant therapy

EXPERIMENTAL

Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery. Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician. Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Drug: 5-FluorouracilDrug: OxaliplatinDrug: CetuximabDrug: DocetaxelProcedure: SurgeryRadiation: Radiotherapy