A Study of Chemoradiation Associated With Nimotuzumab as the Treatment of Locally Advanced Esophageal Cancer (NICE)
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| ClinicalTrials.gov Identifier: NCT01249352 |
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Recruitment Status :
Completed
First Posted : November 29, 2010
Last Update Posted : January 6, 2014
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The primary objective of this study is to assess the efficacy of nimotuzumab in combination with chemotherapy and radiotherapy for the treatment of locally advanced esophageal cancer, comparing it to that of the conventional treatment with radiation and chemotherapy.
The secondary objective of this study is to assess the health-related quality of life for the nimotuzumab in combination with chemotherapy and radiotherapy regimen, compared to the standard chemoradiation regimen in the treatment of inoperable locally advanced esophageal cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Cancer Adenocarcinoma | Drug: Nimotuzumab Drug: Cisplatin Drug: Fluorouracil Radiation: Radiotherapy | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 104 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Randomized, Controlled, Open-Label Study Comparing Standard Chemoradiation Versus Chemoradiation Associated With Nimotuzumab as the Treatment of Locally Advanced Esophageal Cancer |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | November 2013 |
| Actual Study Completion Date : | November 2013 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: STANDARD CHEMORADIATION
Cisplatin 75 mg/m2, IV IV doses on D1 of each chemotherapy cycle, for 4 cycles Fluorouracil 1000 mg/m2, IV IV doses in a 24-hour continuous infusion, from D1 to D4 of each chemotherapy cycle, for 4 cycles. Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day Equivalent to 28 fractions for 5 and a half weeks. |
Drug: Nimotuzumab
200 mg, IV Weekly IV dose for up to 26 weeks. Drug: Cisplatin 75 mg/m2, IV dose on D1 of each chemotherapy cycle, for 4 cycles, always after nimotuzumab. Drug: Fluorouracil 1,000 mg/m2, IV dose in a 24-hour continuous infusion, from D1 to D4, every chemotherapy cycle, for 4 cycles. Radiation: Radiotherapy Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day |
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Experimental: CHEMORADIATION + NIMOTUZUMAB
Nimotuzumab 200 mg, IV weekly IV doses for up to 26 weeks. Cisplatin 75 mg/m2, IV IV dose on D1 of each chemotherapy cycle, for 4 cycles, always after nimotuzumab. Fluorouracil 1000 mg/m2, IV IV dose in a 24-hour continuous infusion, from D1 to D4 of each chemotherapy cycle, for 4 cycles. Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day Equivalent to 28 fractions for 5 and a half weeks. |
Drug: Nimotuzumab
200 mg, IV Weekly IV dose for up to 26 weeks. Drug: Cisplatin 75 mg/m2, IV dose on D1 of each chemotherapy cycle, for 4 cycles, always after nimotuzumab. Drug: Fluorouracil 1,000 mg/m2, IV dose in a 24-hour continuous infusion, from D1 to D4, every chemotherapy cycle, for 4 cycles. Radiation: Radiotherapy Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day |
- Overall survival and assessment of the complete endoscopic response [ Time Frame: 2 years ]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.
- Complete clinical response rate [ Time Frame: 2 years ]
- Time to tumor progression (TTP);
- Complete clinical response rate, defined as the proportion of patients with absence of visible disease in the high endoscopy and in the chest and abdomen computerized tomography, in the population assessable for response;
- Complete endoscopic response rate, defined as the absence of visible disease in the high endoscopy;
- Resectability rate;
- Safety:
- Quality of life, according to the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire;
- Relationship between efficacy and safety and the tumor characteristics.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years;
- Histological prove of SCC or esophageal adenocarcinoma;
- T1N1M0, T2N1M0, T3N0M0, T4N0M0, T3N1M0, T4N1M0, qqTqqNM1a stage, according to the TNM system42;
- Life expectation above 6 months;
- 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);
- Performance status 0, 1, or 2, according to the Eastern Cooperative Oncology Group criteria44 (ECOG) (see Appendix C);
- Creatinine clearance ≥ 60 ml/min, according to the Cockcroft and Gault formula45 (see Appendix D);
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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;
- Adequate calorie ingestion, at the investigator's discretion;
- He/she must have signed the informed consent form
Exclusion Criteria:
- Previous or planned treatment of esophageal carcinoma with surgery, radiotherapy, chemotherapy, or antineoplastic biological therapy;
- Presence of active infection;
- Knowledge of the presence of HIV seropositivity;
- 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;
- Presence of a significant neurological or psychiatric disease, including dementia and seizures, as per the investigator's judgment;
- History of malignant neoplasm, except for adequately treated skin basal carcinoma or SCC, and cervical carcinoma in situ;
- Presence of peripheral neuropathy;
- Knowledge of the presence of hypersensitivity or allergy to drugs that will be administered in this protocol;
- History of severe allergic reaction;
- Pregnancy or lactation;
- Presence of aerodigestive fistula (trachea and/or bronchia);
- Evident presence of trachea and/or bronchia infiltration by the tumor;
- Presence of uncontrolled hypercalcaemia ≥ 2.9 mmol/L (or grade >1, according to the NCI-CTCAE, version 3.0).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249352
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| Responsible Party: | Dr. Gilberto Castro / Dr. Rafael Schimmerling, HCFMUSP |
| ClinicalTrials.gov Identifier: | NCT01249352 |
| Other Study ID Numbers: |
EF024-201 |
| First Posted: | November 29, 2010 Key Record Dates |
| Last Update Posted: | January 6, 2014 |
| Last Verified: | January 2014 |
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Esophageal Cancer Nimotuzumab EF024 EF024-201 |
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Esophageal Neoplasms Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Fluorouracil |
Nimotuzumab Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological |