Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer
This study is currently recruiting participants.
Verified March 2012 by The Second People's Hospital of Sichuan
Sponsor:
The Second People's Hospital of Sichuan
Collaborator:
Biotech Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
LANG Jin-yi, The Second People's Hospital of Sichuan
ClinicalTrials.gov Identifier:
NCT01516996
First received: January 11, 2012
Last updated: March 18, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.
| Condition | Intervention | Phase |
|---|---|---|
|
Oropharyngeal Cancer Hypopharyngeal Cancer |
Drug: docetaxel and cisplatin Radiation: IMRT Biological: Nimotuzumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx |
Resource links provided by NLM:
Further study details as provided by The Second People's Hospital of Sichuan:
Primary Outcome Measures:
- Objective response rate [ Time Frame: 3 months after all the treatment ending ] [ Designated as safety issue: No ]Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
- The Number of Participants with Adverse Events [ Time Frame: Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks ] [ Designated as safety issue: Yes ]Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0 as the two measure of safety.
Secondary Outcome Measures:
- Overall Survival [ Time Frame: From date of randomization until the date of death from any cause,assessed up to 5 years ] [ Designated as safety issue: No ]
- Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years ] [ Designated as safety issue: No ]
- Evaluate the Local control Rate in 1 to 5 years. [ Time Frame: Participants will be followed every year for the duration of 5 years ] [ Designated as safety issue: No ]To evaluate each year until 5 years later
- Tumor-Free Survival [ Time Frame: From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years ] [ Designated as safety issue: No ]
- Non-metastatic Rate [ Time Frame: The time from randomization until distant relapse occur,assessed up to 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Neoadjuvant and CCRT |
Drug: docetaxel and cisplatin
IMRT is administered with chemotherapy from week 7 to week 13
Other Name: CCRT
|
| Experimental: Neoadjuvant and CCRT and Nimotuzumab |
Drug: docetaxel and cisplatin
IMRT is administered with chemotherapy from week 7 to week 13
Other Name: CCRT
Biological: Nimotuzumab
Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13~14 weeks
|
Detailed Description:
Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires combined-modality therapy. Recent studies have showed that induction chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent benefit in local control rates, but its impact on distant failure is inconsistent. Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN. Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent form
- Histologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx
- The tumor mass had to be measurable
- Karnofsky performance status ≥70
- Life expectancy estimated than 6 months
- Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L；
- Hepatic: AST/ALT＜1.5 times upper limit of normal (ULN)；serum bilirubin<1.5 times ULN;
- Renal: Creatinine＜1.5 times ULN；
Exclusion Criteria:
- Known distant metastases
- Primary tumor and nodes received surgery(except of biopsy)
- Received other anti EGFR monoclonal antibody treatment
- Previous chemotherapy or radiotherapy
- Participation in other interventional clinical trials within 1 month
- Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix)
- History of serious allergic or allergy
- History of Serious lung or heart disease
- Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516996
Locations
| China, Gansu | |
| Gansu Province Medical Science Institute | Active, not recruiting |
| Lanzhou, Gansu, China, 730050 | |
| China, Guangxi | |
| Guangxi Tumor Hospital | Active, not recruiting |
| Nanning, Guangxi, China, 530021 | |
| China, Guizhou | |
| GuiZhou Cancer Hospital | Active, not recruiting |
| Guiyang, Guizhou, China, 550004 | |
| China, Neimenggu | |
| Neimenggu Tumor Hospital | Active, not recruiting |
| Baotou, Neimenggu, China, 014030 | |
| China, Ningxia | |
| The Tumor Affiliated Hospital of Ningxia Medical University General Hospita | Active, not recruiting |
| Yinchuan, Ningxia, China, 750004 | |
| China, Qinghai | |
| Qinghai Five Hospital | Active, not recruiting |
| Xining, Qinghai, China | |
| China, Shanxi | |
| Xijing Hospital | Active, not recruiting |
| Xi-an, Shanxi, China, 710032 | |
| ShanXi Cancer Hospital | Active, not recruiting |
| Xian, Shanxi, China, 710061 | |
| China, Sichuan | |
| The Second People's Hospital of Sichuan | Recruiting |
| Chengdu, Sichuan, China, 610041 | |
| Contact: Peng Xu, M.D. 15828312322 xupeng4618@163.com | |
| West China Hospital, Sichuan University | Active, not recruiting |
| Chengdu, Sichuan, China, 610041 | |
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Active, not recruiting |
| Chongqing, Sichuan, China, 400042 | |
| China, Xinjiang | |
| Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University | Active, not recruiting |
| Wulumuqi, Xinjiang, China, 830000 | |
| China, Yunnan | |
| Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University | Active, not recruiting |
| Kunming, Yunnan, China, 652100 | |
Sponsors and Collaborators
The Second People's Hospital of Sichuan
Biotech Pharmaceutical Co., Ltd.
Investigators
| Principal Investigator: | Yi J Lang, M.D. | Radiotherapy department |
More Information
No publications provided
| Responsible Party: | LANG Jin-yi, Professor of radiotherapy department, The Second People's Hospital of Sichuan |
| ClinicalTrials.gov Identifier: | NCT01516996 History of Changes |
| Other Study ID Numbers: | BT-IST-SCCHN-036 |
| Study First Received: | January 11, 2012 |
| Last Updated: | March 18, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by The Second People's Hospital of Sichuan:
|
Neoadjuvant Concurrent Chemoradiotherapy,CCRT Nimotuzumab Locoregionally Advanced Oropharynx |
Hypopharynx cancer Randomized Multicenter |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Oropharyngeal Neoplasms Hypopharyngeal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms |
Neoplasms by Site Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Docetaxel Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013