Clinical trial · Interventional
Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer
Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck
NCT00011999CI-TRIAL-00019805completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy following surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgery, chemotherapy and radiation therapy
- description
- Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
- interventionNames
- Drug: cisplatin
- Drug: paclitaxel
- Procedure: conventional surgery
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Patient tolerance of the treatment regimen
- timeFrame
- From registration to end of treatment
Secondary outcomes (5)
- measure
- Frequency of grade 5 and acute non-hematologic grade 4 toxicity
- timeFrame
- From start of induction chemotherapy to 90 days after start of radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx
* Gross total resection completed or planned
* No less than gross total resection
* No disease requiring staging surgery
* Prior gross total resection completed with one or more of the following risk factors:
* Histologically proven multiple lymph node metastases
* At least 1 lymph node with extracapsular extension of tumor
* Positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection OR
* Gross total resection planned within 14 days of study enrollment with anticipated need for postoperative radiotherapy for one of the following:
* Multiple clinically/radiologically evident lymph nodes of at least 1.5 cm
* Single clinically/radiologically evident lymph node of at least 3 cm
* Histologically proven lymph node metastases
* No T3, N0 glottic cancer
* No nasopharyngeal or paranasal sinus carcinoma
* No distant metastases
PATIENT CHARACTERISTICS:
Age:
* 21 and over
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* White blood cell (WBC) at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than 1.5 times ULN
Renal:
* Creatinine no greater than 1.5 ULN
Cardiovascular:
* No unstable angina
* No myocardial infarction within the past 6 months unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty
* No uncontrolled arrhythmia
* No second or third degree heart block or other clinically significant conduction system abnormality unless pacemaker is in place
Pulmonary:
* No severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pre-existing grade 2 or greater peripheral neurotoxicity
* No other prior malignancy within the past 3 years except low-risk nonmelanomatous skin cancer; carcinoma in situ (e.g., breast, cervix, or bladder); or stage T1-2, low to moderate grade prostate cancer
* No significant wound infection
* No fistula
* No major wound dehiscence
* Nutritional status adequate
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Concurrent colony-stimulating factors for neutropenic fever during study chemoradiotherapy allowed
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy to head and neck
Surgery:
* See Disease CharacteristicsReferences
Publications (2)
- RESULTRosenthal DI, Harris J, Forastiere AA, Weber RS, Ridge JA, Myers JN, Garden AS, Kuettel MR, Sidhu K, Schultz CJ, Trotti A, Ang KK. Early postoperative paclitaxel followed by concurrent paclitaxel and cisplatin with radiation therapy for patients with resected high-risk head and neck squamous cell carcinoma: report of the phase II trial RTOG 0024. J Clin Oncol. 2009 Oct 1;27(28):4727-32. doi: 10.1200/JCO.2008.21.4197. Epub 2009 Aug 31. PMID 19720915
- RESULTRosenthal DJ, Harris J, Forastiere AA, et al.: Early postoperative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy (RT) (phase II trial RTOG H-0024) is well tolerated for patients with resected, high-risk squamous carcinoma of the head and neck (HNSCC). [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-1111, S322, 2004.