NCT00095875 · REGISTRY CONDITION SEARCH

Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2013-11-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival and Disease-specific Survival as Assessed by Disease Progression or Death and Log Rank Tests at the Median, and 2, 3, and 5 Years

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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 therapy
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: carboplatin
Drug: cisplatin
Drug: docetaxel
Drug: fluorouracil
label
Arm I
type
EXPERIMENTAL
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.
intervention Names
Drug: cisplatin
label
Arm II
type
EXPERIMENTAL

interventions

arm Group Labels
Arm I
description
Given IV
name
carboplatin
other Names
Paraplatin
type
DRUG
arm Group Labels
Arm I
Arm II
description
Given IV
name
cisplatin
other Names
Platinol
type
DRUG
arm Group Labels
Arm I
description
Given IV
name
docetaxel
other Names
Taxotere
type
DRUG
arm Group Labels
Arm I
description
Given IV
name
fluorouracil
other Names
Efudex
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 145
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
To compare the 3-year survival achieved by docetaxel/cisplatin/5-FU based sequential therapy with platinum based chemo radiotherapy in patients with locally advanced SCCHN. Overall survival is defined as the time from date of randomisation to death from any cause. Patients alive at the time of current analysis were censored at the date last known to be alive.Kaplan-Meier method was used to estimate overall survival
measure
Overall Survival
time Frame
3-years

secondary Outcomes

description
Progression free survival was defined as the time from date of randomisation to disease progression or death from any cause without progression whichever occurred first; otherwise, patients were censored at the date last known to be free of progression.
measure
Progression-free Survival and Disease-specific Survival as Assessed by Disease Progression or Death and Log Rank Tests at the Median, and 2, 3, and 5 Years
time Frame
5 years

Full study description

brief Summary: 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.
detailed Description: OBJECTIVES: Primary * Compare 3-year survival of patients with previously untreated stage III or IV squamous cell carcinoma of the head and neck treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by radiotherapy and carboplatin or docetaxel vs radiotherapy and cisplatin only. Secondary * Compare 2-year progression-free status in patients treated with these regimens. * Compare 5-year survival of patients treated with these regimens. * Compare 3- and 5-year progression-free survival of patients treated with these regimens. * Compare the complete response rate in patients treated with these regimens. * Compare tumor site-specific survival in patients treated with these regimens. * Compare functional organ preservation in patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. * Correlate tissue and germline markers with response, local/regional control, and the development of distant metastases in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I: 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. * Arm II: Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks. Quality of life is assessed at baseline and then at 3, 12, and 24 months. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.

Source references

references

citation
Haddad 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
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice