Clinical trial · Interventional
A Pilot Study of Induction Chemotherapy Followed by Surgery for Locally Advanced Resectable Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of enrollment
Summary
Brief summary (as posted)
This is a non-randomized open-label investigator initiated pilot study comparing follow-up therapy of advanced head and neck cancer subjects initially treated with triple induction chemotherapy. Subjects will receive surgical treatment or combined chemoradiation therapy based on the subject's apparent clinical response. Spared use of radiation therapy for selective patients who have a complete response to induction chemotherapy could improve well being of this patient population without compromising survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conservation surgery | Procedure | — | UNRESOLVED |
| radiation combined with weekly carboplatin | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- radiation and weekly carboplatin
- interventionNames
- Other: radiation combined with weekly carboplatin
- type
- OTHER
- label
- conservation surgery
- interventionNames
- Procedure: conservation surgery
Primary outcomes (1)
- measure
- Rate of pathologic complete response
- timeFrame
- 42 months
- description
- To assess the rate of pathologic complete response of subjects (based on analysis of the surgical specimen), in both the primary site as well as the lymph nodes, with resectable stage III-IV squamous cell carcinoma of the oropharynx treated with TPF induction chemotherapy followed by conservation (organ preservation) surgery for clinically complete responders
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent document. 2. Histologically confirmed Stage III-IV (T1, T2, T3) (N0-N2) squamous cell carcinoma of the oropharynx staged according to AJCC guidelines. 3. The subject must be considered surgically resectable via a transoral approach at the time of presentation. 4. Age \>18 years 5. Life expectancy \>/= 5 years 6. ECOG performance status \<2 7. Subject must have measurable disease, at least one lesion accurately measured in at least one dimension as \>10 mm with CT scan. 8. Hematologic Absolute neutrophil count \> 1,000/mm3, Hemoglobin \> 8.0 g/dl Platelet count \> 100,000/mm3 Leukocytes \>3,000/mcL 9. Hepatic Total Bilirubin ≤ ULN; AST and ALT and Alkaline Phosphatase within the eligible range 10. Renal - creatinine within normal institutional limits or \>60 mL/min/1.73 m2 creatinine \> institutional normal 11. Women of childbearing potential with negative pregnancy test. 12. Men and women of childbearing age willing to use effective contraception Exclusion Criteria: 1. N3 nodal disease according to AJCC guidelines 2. Retropharyngeal nodal involvement 3. Trismus 4. Second primary head and neck tumor unless it is/was a basal or squamous cell skin cancer 5. Prior surgery, chemotherapy, biologic or radiotherapy for a head or neck malignancy 6. Concurrent investigational agent or intervention (within 90 days of screening visit) 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxol, cisplatin, 5- fluorouracil, or carboplatin. 8. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80 9. Breastfeeding women 10. Pre-existing peripheral neuropathy grade \> 3 11. Evidence of distant metastatic disease 12. Unknown primary site 13. Prior or concurrent malignancies (excluding adequately treated basal or squamous cell skin cancer, in situ cervical cancer, stage I or II cancer from which the subject has been in complete remission for at least 12 months (excluding head and neck), any cancer from which the subject has been cancer free for 5 years) 14. History of allergies to any of the pre-medications. 15. Investigator consideration based upon screening interview and/or procedures 16. Evidence of bone invasion/destruction 17. Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 18. Pregnant women 19. History of HIV, hepatitis B, hepatitis C, or delta antigen 20. Known allergy to India Ink or methylene blue
References
Publications (5)
- BACKGROUNDRobbins KT, Howell SB, Williams JS. Intra-arterial chemotherapy for head and neck cancer: is there a verdict? Cancer. 2010 May 1;116(9):2068-70. doi: 10.1002/cncr.24930. No abstract available. PMID 20186833
- BACKGROUNDMalone J, Robbins KT. Neck dissection after chemoradiation for carcinoma of the upper aerodigestive tract: indications and complications. Curr Opin Otolaryngol Head Neck Surg. 2010 Apr;18(2):89-94. doi: 10.1097/MOO.0b013e32833693e7. PMID 20125024
- BACKGROUNDMalone JP, Gerberi MA, Vasireddy S, Hughes LF, Rao K, Shevlin B, Kuhn M, Collette D, Tennenhouse J, Robbins KT. Early prediction of response to chemoradiotherapy for head and neck cancer: reliability of restaging with combined positron emission tomography and computed tomography. Arch Otolaryngol Head Neck Surg. 2009 Nov;135(11):1119-25. doi: 10.1001/archoto.2009.152. PMID 19917925
- BACKGROUNDRogers LQ, Rao K, Malone J, Kandula P, Ronen O, Markwell SJ, Courneya KS, Robbins KT. Factors associated with quality of life in outpatients with head and neck cancer 6 months after diagnosis. Head Neck. 2009 Sep;31(9):1207-14. doi: 10.1002/hed.21084. PMID 19360748
- BACKGROUNDRobbins KT, Homma A. Intra-arterial chemotherapy for head and neck cancer: experiences from three continents. Surg Oncol Clin N Am. 2008 Oct;17(4):919-33, xi. doi: 10.1016/j.soc.2008.04.015. PMID 18722926