A Study of Chemoradiation Associated With Nimotuzumab as the Treatment of Locally Advanced Esophageal Cancer (NICE)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Adenocarcinoma |
Drug: Nimotuzumab Drug: Cisplatin Drug: Fluorouracil Radiation: Radiotherapy |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- Overall survival and assessment of the complete endoscopic response [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- 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.
| Estimated Enrollment: | 104 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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);
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).
Contacts and Locations| Brazil | |
| Hospital Universitário de Brasília | |
| Brasília, DF, Brazil | |
| Hospital Evangélico do Cachoeiro do Itapemirim | |
| Cachoeiro do Itapemirim, ES, Brazil | |
| Santa Casa de Misericórdia de BH | |
| Belo Horizonte, MG, Brazil | |
| Hospital Erasto Gaetner | |
| Curitiba, PR, Brazil | |
| Instituto Nacional do Câncer (INCA) | |
| Rio de Janeiro, RJ, Brazil | |
| Hospital Geral de Bonsucesso | |
| Rio de Janeiro, RJ, Brazil | |
| Hospital da cidade de Passo Fundo | |
| Passo Fundo, RS, Brazil | |
| Hospital Nossa Senhora da Conceição | |
| Porto Alegre, RS, Brazil | |
| Hospital de Clínicas de Porto Alegre | |
| Porto Alegre, RS, Brazil | |
| Centro de Novos Tratamentos de Itajaí | |
| Itajaí, SC, Brazil | |
| Hospital Municipal São José | |
| Joinville, SC, Brazil | |
| Hospital Amaral Carvalho | |
| Jau, SP, Brazil | |
| Centro Oncológico Mogi das Cruzes | |
| Mogi das Cruzes, SP, Brazil | |
| Faculdade de Medicina do ABC / CEPHO | |
| Santo André, SP, Brazil | |
| Centro de Estudos de Investigações Clíncas (CEIC) | |
| São Caetano do Sul, SP, Brazil | |
| Hospital de Base | |
| São José do Rio Preto, SP, Brazil | |
| Hospital São Paulo (UNIFESP) | |
| São Paulo, SP, Brazil | |
| Instituto do Câncer do Estado de São Paulo | |
| São Paulo, SP, Brazil | |
| Hospital Santa Marcelina | |
| São Paulo, SP, Brazil | |
More Information
No publications provided
| Responsible Party: | Dr. Gilberto Castro / Dr. Rafael Schimmerling, HCFMUSP |
| ClinicalTrials.gov Identifier: | NCT01249352 History of Changes |
| Other Study ID Numbers: | EF024-201 |
| Study First Received: | November 25, 2010 |
| Last Updated: | December 23, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research Brazil: National Health Surveillance Agency |
Keywords provided by Eurofarma Laboratorios S.A.:
|
Esophageal Cancer Nimotuzumab EF024 EF024-201 |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Esophageal Diseases Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 19, 2013