Know Cancer

forgot password

A Phase II, Randomized, Controlled, Open-Label Study Comparing Standard Chemoradiation Versus Chemoradiation Associated With Nimotuzumab as the Treatment of Locally Advanced Esophageal Cancer

Phase 2/Phase 3
18 Years
Open (Enrolling)
Esophageal Cancer, Adenocarcinoma

Thank you

Trial Information

A Phase II, Randomized, Controlled, Open-Label Study Comparing Standard Chemoradiation Versus Chemoradiation Associated With Nimotuzumab as the Treatment of Locally Advanced Esophageal Cancer

This will be a phase II, randomized, controlled, open-label, multicenter, and two-arm study.
The study will be conducted in Brazil and has the purpose of determining the activity and
safety of nimotuzumab in terms of overall survival, TTP, clinical and endoscopic response
rates, resectability rate, toxicity profile, and quality of life. All participating patients
will sign a consent form before they undergo any study-related procedure. The eligible
patients will have locally advanced esophageal cancer, and they will be randomized to one of
two treatment groups. Randomization will be centrally coordinated by the sponsor and
performed by means of the electronic CRF itself.

Inclusion Criteria:

1. Age ≥ 18 years;

2. Histological prove of SCC or esophageal adenocarcinoma;

3. T1N1M0, T2N1M0, T3N0M0, T4N0M0, T3N1M0, T4N1M0, qqTqqNM1a stage, according to the TNM

4. Life expectation above 6 months;

5. Inoperable superior, medial, or distal third esophageal cancer, including GE junction
tumors, defined as type I and II tumors in the Siewert classification43 (see
Appendix B);

6. Performance status 0, 1, or 2, according to the Eastern Cooperative Oncology Group
criteria44 (ECOG) (see Appendix C);

7. Creatinine clearance ≥ 60 ml/min, according to the Cockcroft and Gault formula45
(see Appendix D);

8. Adequate body functions, indicated by

- Creatinine clearance ≥ 60 ml/min;

- Bilirubin, transaminase, alkaline phosphatase, and gamma-GT < 1,5 x the upper
limit of normal;

- leucocytes ≥ 3000/μl;

- granulocytes ≥ 1500/ μl;

- hemoglobin ≥ 9 g/dl;

- platelets ≥ 80000/ μl;

9. Adequate calorie ingestion, at the investigator's discretion;

10. He/she must have signed the informed consent form

Exclusion Criteria:

1. Previous or planned treatment of esophageal carcinoma with surgery, radiotherapy,
chemotherapy, or antineoplastic biological therapy;

2. Presence of active infection;

3. Knowledge of the presence of HIV seropositivity;

4. Presence of severe comorbidities that, in the investigator's opinion, will put the
patient at a significantly higher risk or will damage the protocol compliance;

5. Presence of a significant neurological or psychiatric disease, including dementia and
seizures, as per the investigator's judgment;

6. History of malignant neoplasm, except for adequately treated skin basal carcinoma or
SCC, and cervical carcinoma in situ;

7. Presence of peripheral neuropathy;

8. Knowledge of the presence of hypersensitivity or allergy to drugs that will be
administered in this protocol;

9. History of severe allergic reaction;

10. Pregnancy or lactation;

11. Presence of aerodigestive fistula (trachea and/or bronchia);

12. Evident presence of trachea and/or bronchia infiltration by the tumor;

13. Presence of uncontrolled hypercalcaemia ≥ 2.9 mmol/L (or grade >1, according to the
NCI-CTCAE, version 3.0).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival and assessment of the complete endoscopic response

Outcome Description:

The primary endpoint of this study is the overall survival at the end of Phase II. At the end of Phase II, the assessment of the complete endoscopic response, and the regimen safety will be used to decide if the study will continue to Phase III.

Outcome Time Frame:

2 years

Safety Issue:



Brazil: National Committee of Ethics in Research

Study ID:




Start Date:

January 2009

Completion Date:

September 2013

Related Keywords:

  • Esophageal Cancer
  • Adenocarcinoma
  • Esophageal Cancer
  • Nimotuzumab
  • EF024
  • EF024-201
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms