Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

NCT00057785 | Completed Phase 2 Results DMC

• 2 other identifiers: RTOG-0225CDR0000269314
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 17

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.

Conditions

Head and Neck Cancer; Oral Complications of Radiation Therapy; Radiation Toxicity

Keywords

oral complications of radiation therapy; radiation toxicity; stage I squamous cell carcinoma of the nasopharynx; stage II squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx

Outcome Measures

Primary Outcomes (1)

• Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered

  Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.

  From start of treatment to end of treatment

Secondary Outcomes (5)

• Rate of Xerostomia at 1 Year (Grade ≥ 2)

  From start of treatment to 1 year

• Rate of Locoregional Control at 2 Years

  From registration to 2 years

• Whole Mouth Saliva Output Relative to Pretreatment Measurements

  From start of treatment to 1 year

• Other Acute and Late Toxicities

  From start of treatment to last follow-up

• Chemotherapy Compliance

  From start of treatment to end of treatment

Study Arms (1)

IMRT +/- chemotherapy

EXPERIMENTAL

Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+

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

Interventions

cisplatin DRUG

100 mg/m\^2 intravenously on days 1, 22, and 43 and 80 mg/m\^2 intravenously on days 71, 99, and 127

IMRT +/- chemotherapy

fluorouracil DRUG

1000 mg/m\^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130

IMRT +/- chemotherapy

Intensity modulated radiation therapy RADIATION

The gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume \[CTV\] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days.

IMRT +/- chemotherapy

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx * WHO I-III * No stage IVC disease * No evidence of distant metastasis * Measurable or evaluable disease * Must have been treated with primary radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * White blood cell count (WBC) at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Not specified Renal * Creatinine no greater than 1.6 mg/dL * Creatinine clearance at least 60 mL/min Other * Not pregnant (If stage T2b or greater or node-positive disease) * Negative pregnancy test (If stage T2b or greater or node-positive disease) * No other prior head and neck cancer * No other malignancy within the past 5 years except nonmelanoma skin cancer * No active untreated infection * No other major medical or psychiatric illness that would preclude study entry * Nutritional and general physical condition compatible with radiotherapy NOTE: \*If stage T2b or greater or node-positive disease PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 6 months since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 6 months since prior radiotherapy for head and neck cancer Surgery * No prior head and neck surgery to the primary tumor or lymph nodes except incisional or excisional biopsies Other * No other concurrent experimental therapy for cancer * No amifostine or pilocarpine during or for 3 months after radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (17)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California Davis Cancer Center

Davis, California, 95616, United States

Location

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, 95815, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Albuquerque Regional Medical Center at Lovelace Sandia Health System

Albuquerque, New Mexico, 87102, United States

Location

Akron City Hospital

Akron, Ohio, 44304, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase-Temple Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• Chen A, Lee N, Yang C, Liu T, Narayan S, Vijayakumar S, Purdy J. Comparison of intensity-modulated radiotherapy using helical tomotherapy and segmental multileaf collimator-based techniques for nasopharyngeal carcinoma: dosimetric analysis incorporating quality assurance guidelines from RTOG 0225. Technol Cancer Res Treat. 2010 Jun;9(3):291-8. doi: 10.1177/153303461000900308.

  PMID: 20441239 RESULT

• Lee N, Harris J, Garden AS, Straube W, Glisson B, Xia P, Bosch W, Morrison WH, Quivey J, Thorstad W, Jones C, Ang KK. Intensity-modulated radiation therapy with or without chemotherapy for nasopharyngeal carcinoma: radiation therapy oncology group phase II trial 0225. J Clin Oncol. 2009 Aug 1;27(22):3684-90. doi: 10.1200/JCO.2008.19.9109. Epub 2009 Jun 29.

  PMID: 19564532 RESULT

• Lee NY, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT ± chemotherapy for nasopharyngeal carcinoma (RTOG 0225): preliminary results. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-23, S13-14, 2007.

  RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiation Injuries

Interventions

Cisplatin; Fluorouracil; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

Study Officials

• Nancy Lee, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: February 1, 2003
• Primary Completion: February 1, 2007
• Study Completion: December 1, 2016
• Last Updated: February 17, 2017
• Results First Posted: October 13, 2014

Record last verified: 2016-12

Locations

US (17)