Phase 3
Completed N=940
Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Source: ClinicalTrials.gov NCT00265941 ↗Enrolled (actual)
940
Serious AEs
49.9%
Results posted
Dec 2017
Primary outcomePrimary: Progression-free Survival (PFS) (3-year Rate Reported) — 61.2; 58.9 percentage of participants — p=0.76
◆ Published Evidence
Highly cited
832citations · ~69 / year
Randomized phase III trial of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III to IV head and neck carcinoma: RTOG 0522.
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin may also make tumor cells more sensitive to radiation therapy. 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 radiation therapy and cisplatin together with cetuximab may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without cetuximab in treating head and neck cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy, cisplatin, and cetuximab to see how well they work compared to radiation therapy and cisplatin in treating patients with stage III or stage IV head and neck cancer.
Linked Publications (5)
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Randomized phase III trial of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III to IV head and neck carcinoma: RTOG 0522.
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Metabolic tumor volume as a prognostic imaging-based biomarker for head-and-neck cancer: pilot results from Radiation Therapy Oncology Group protocol 0522.
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Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Accelerated Radiation Plus Cisplatin With or Without Cetuximab for Locally Advanced Head and Neck Carcinoma: NRG Oncology Radiation Therapy Oncology Group 0522.
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Long-Term Update of NRG/RTOG 0522: A Randomized Phase 3 Trial of Concurrent Radiation and Cisplatin With or Without Cetuximab in Locoregionally Advanced Head and Neck Cancer.
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Treatment Interruption and Outcomes in Head and Neck Cancer: A Secondary Analysis of 3 Randomized Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) (3-year Rate Reported) |
61.2; 58.9 | 0.76 |
| SECONDARY Overall Survival (OS) (3-year Rate Reported) |
72.9; 75.8 | 0.32 |
| SECONDARY Local-regional Failure (LRF) (3-year Rate Reported) |
19.9; 25.9 | 0.97 |
| SECONDARY Rate of Mucositis Toxicity ≥ Grade 3 |
33.3; 43.2 | — |
| SECONDARY Rate of Other Toxicity ≥ Grade 3 (Not Mucositis) |
89.3; 91.9 | — |
| SECONDARY Rate of Patients Who Tolerated Treatment |
84.8; 70.7 | — |
| SECONDARY Rate of Deaths ≤ 30 Days After Discontinuation of Protocol Treatment |
1.8; 2.0 | — |
| SECONDARY Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D) |
0.78; 0.77; 0.84; 0.84 | 0.74 |
| SECONDARY Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50 |
0.80; 0.85; 0.37; 0.37; 0.62; 0.63 | 0.13 |
| SECONDARY Quality of Life as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-HN) at 12 Months |
-0.41; -5.11 | 0.016 sig |
| SECONDARY Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF |
63.5; 60.3; 76.7; 75.0; 21.7; 19.2 | 0.60 |
| SECONDARY Correlation of Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) With PFS, OS, and LRF |
55.9; 85.3; 85.3; 91.2; 32.4; 11.8 | 0.01 sig |
| SECONDARY 2-year Nodal Relapse Rates in Clinical N2-3 Patients by Post-treatment PET/CT Finding and Nodal Response |
3.9; 33.3; 16.7; 11.1 | — |
Eligibility Criteria
Inclusion criteria
- Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oropharynx, hypopharynx, or larynx;
- Selected stage III or IV disease (T2N2-3M0, T3-4 any N M0); Note: Patients with T1, any N, or T2N1 tumors are not eligible.
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination within 4 weeks prior to registration, including assessment of weight and weight loss in past 6 months and an examination by a Medical Oncologist;
- Chest x-ray (or Chest CT scan or PET/CT scan) within 6 weeks prior to registration;
- CT scan or MRI of the head and neck (of the primary tumor and neck nodes) or PET/CT scan within 6 weeks prior to registration; see Section 6.11 for details of PET scans. Note: A PET/CT can only be used instead of a CT scan or MRI if the CT is a high quality scan with contrast.
- Left ejection fraction determined by echocardiogram and/or multiple gated acquisition (MUGA) technique within 12 weeks of registration;
- Zubrod Performance Status 0-1;
- Age > 18;
- Adequate bone marrow function, defined as follows:
- Absolute neutrophil count (ANC) > 1, 800 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study;
- Platelets > 100, 000 cells/mm3 based upon complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study;
- Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.)
- Adequate hepatic function, defined as follows:
- Bilirubin 12.5 mg/dl;
- Glucose 250 mg/dl;
- Magnesium 3 mg/dl;
- Potassium 6 mmol/L;
- Sodium 155 mmol/L
- Pregnant or lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Prior allergic reaction to the study drug(s) involved in this protocol;
- Prior therapy that specifically and directly targets the EGFR pathway;
- Prior severe infusion reaction to a monoclonal antibody.
Data sourced from ClinicalTrials.gov (NCT00265941) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.