Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer

NCT00608205 | Completed Phase 3 Results DMC

• 2 other identifiers: CASE3307NCI-2010-01197
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the larynx

Outcome Measures

Primary Outcomes (1)

• Relapse Free Survival

  Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..

  at 2 yrs from start of study

Secondary Outcomes (41)

• Patterns of Failure

  2 years from start of study

• Overall Survival

  2 yrs from start of study

• Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor

  at 12 weeks after completing chemoradiotherapy

• Number of Patients With a Pathological(Final)Complete Response

  at 12 weeks after completing chemoradiotherapy and surgery

• Disease Recurrence

  2 years after start of study

Study Arms (2)

Arm A: Radiation with concurrent Cisplatin

ACTIVE COMPARATOR

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Drug: cisplatin; Radiation: radiation therapy

Arm B: Radiation with concurrent 5-FU and Cisplatin

EXPERIMENTAL

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Drug: cisplatin; Drug: fluorouracil; Radiation: radiation therapy

Interventions

cisplatin DRUG

Given IV

Also known as: CDDP

Arm A: Radiation with concurrent Cisplatin; Arm B: Radiation with concurrent 5-FU and Cisplatin

fluorouracil DRUG

Given IV

Arm B: Radiation with concurrent 5-FU and Cisplatin

radiation therapy RADIATION

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks

Also known as: radiation

Arm A: Radiation with concurrent Cisplatin; Arm B: Radiation with concurrent 5-FU and Cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible.
• Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years.
• Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible.
• Patients who might be a poor-compliance risk are ineligible.
• Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (2)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Fluorouracil; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Dr. David Adelstein
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

adelstd@ccf.org

216-444-9310

Study Officials

• David J. Adelstein, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Panayiotis Savvides, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: August 1, 2016
• Last Updated: August 6, 2020
• Results First Posted: September 19, 2013

Record last verified: 2020-07

Locations

US (2)