Head and neck cancer: which chemo combo works best?
NCT ID NCT01154920
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two chemotherapy combinations for people with advanced head and neck cancer that hasn't been treated yet. One group gets paclitaxel, carboplatin, and cetuximab weekly; the other gets cetuximab, docetaxel, cisplatin, and fluorouracil in cycles. The goal is to see which combination helps patients live longer without the cancer growing, and to compare side effects. About 128 participants will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy drugs (paclitaxel, carboplatin, cetuximab, docetaxel, cisplatin, fluorouracil)
- What this could lead to
- If successful, this trial could identify a more effective chemotherapy regimen for advanced head and neck cancer, potentially improving survival and quality of life.
- What could go wrong
- This is a phase 2 trial with only 128 participants, so results may not apply to all patients. Chemotherapy side effects can be severe, and the better regimen may still have limited long-term benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2010
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx. 2. Biopsy material sufficient for HPV status determination available 3. Patients should have stage IV disease, stage T0-4 N2b-2c/3 M0 (for nasopharynx patients, stage N1 is eligible). Measurable disease in either the T or N site by RECIST is required. 4. Patients with stage Tx primary disease are eligible if there is N2b-c/3 lymphadenopathy 5. ECOG PS 0-1 6. Age \>/= 18 years 7. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC \>/= 1500 cells/mm\^3 and platelet count \>/= 100,000 cells/mm\^3; adequate hepatic function with bilirubin \</= ULN (excluding Gilbert's disease), AST and ALT may be up to 2.5 x ULN if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4 x ULN if AST and ALT are normal. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. 8. Creatinine clearance \>/=40 ml/min determined by 24 hour collection or nomogram:CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 or CrCl female = 0.85 x (CrCl male) 9. Patients should have no serious acute or chronic co-morbid condition, or acute infection, which in the judgment of the attending physician would affect administration of the induction chemotherapy regimens. 10. Patients must sign a study-specific informed consent form Exclusion Criteria: 1. Histology other than squamous cell carcinoma 2. Proven distant metastases (below the clavicle) by clinical or radiographic measures 3. ECOG\>1 4. Prior chemotherapy, within the previous 3 years 5. Prior radiotherapy to the head and neck 6. Prior cetuximab therapy or prior therapy with any other drug that targets the EGFR pathway 7. Initial surgical resection rendering the patient clinically and radiologically disease free 8. Simultaneous primary invasive cancers, excluding superficial non-melanoma skin cancers 9. Patients with a history of another malignancy (excluding non melanoma skin cancers, and cancers treated \> 3 years prior for which patient remains continuously disease free 10. Men and women of childbearing potential (WOCBP) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter 11. Women who are pregnant or breastfeeding 12. Pre-existing peripheral neuropathy CTCAE Grade 2 or worse 13. Hemoglobin \< 8.0g/dL 14. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, 20115, United States
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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