Clinical trial · Interventional
Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)
A Randomized Phase III Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatinum-Based Chemoradiotherapy [PARADIGM TRIAL]
NCT00095875CI-TRIAL-00012685completedPhase 3Results postedClinicalTrials.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, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in 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 may kill more tumor cells. It is not yet known which regimen of chemotherapy and radiation therapy is most effective in treating head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have 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 |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
- interventionNames
- Drug: carboplatin
- Drug: cisplatin
- Drug: docetaxel
- Drug: fluorouracil
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
List of Inclusion Criteria:
* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
* Stage III or IV\* disease
* One of the following primary tumor sites:
* Oral cavity
* No mandible invasion
* Oropharynx
* Hypopharynx
* Larynx
* The following primary tumor sites are excluded:
* Nasal cavity
* Paranasal cavity
* Nasopharynx NOTE: \*No evidence of distant metastases by chest x-ray, abdominal ultrasound, or CT scan (for patients with liver function test abnormalities) or bone scan (for patients with local symptoms)
* At least 1 uni- or bi-dimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin \> 10 g/dL
Hepatic
* Bilirubin normal
* AST or ALT within eligibility range
* Alkaline phosphatase within eligibility range
Renal
* Creatinine clearance \> 60 mL/min
Cardiovascular
* No unstable cardiac disease despite treatment
* No myocardial infarction within the past 6 months
Pulmonary
* No chronic obstructive pulmonary disease, defined as requiring hospitalization for pneumonia or respiratory decompensation within the past year
* Obstruction caused by the tumor allowed
Neurologic
* No symptomatic peripheral neuropathy \> grade 2
* No symptomatic altered hearing \> grade 2
* No history of significant neurologic or psychiatric disorders, including dementia or seizures
Other
* No active drug addiction, including alcohol, cocaine, or intravenous drugs within the past 6 months
* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or other cancer curatively treated by surgery alone
* No active, clinically significant, uncontrolled infection
* No autoimmune disease requiring therapy
* No unhealed or clinically active peptic ulcer disease
* No hypercalcemia
* No other serious illness or medical condition
* No involuntary weight loss \> 25% of body weight within the past 2 months
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
Surgery
* No prior organ transplantation
* No prior surgery for this cancer
* Biopsy allowed
Other
* More than 30 days since prior participation in another investigational study
* No other concurrent anticancer therapyReferences
Publications (1)
- RESULTHaddad R, O'Neill A, Rabinowits G, Tishler R, Khuri F, Adkins D, Clark J, Sarlis N, Lorch J, Beitler JJ, Limaye S, Riley S, Posner M. Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial. Lancet Oncol. 2013 Mar;14(3):257-64. doi: 10.1016/S1470-2045(13)70011-1. Epub 2013 Feb 13. PMID 23414589