Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00011999
First received: March 3, 2001
Last updated: October 8, 2013
Last verified: October 2013

March 3, 2001
October 8, 2013
March 2001
February 2004   (final data collection date for primary outcome measure)
Patient tolerance of the treatment regimen [ Time Frame: From registration to end of treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00011999 on ClinicalTrials.gov Archive Site
  • Frequency of grade 5 and acute non-hematologic grade 4 toxicity [ Time Frame: From start of induction chemotherapy to 90 days after start of radiation therapy ] [ Designated as safety issue: Yes ]
  • Frequency of other acute and late toxicity [ Time Frame: From start of induction chemotherapy to last follow-up ] [ Designated as safety issue: Yes ]
  • Local-regional control [ Time Frame: From registration to date of failure (local or regional progression) or death or last follow-up. Analysis occurs after patients have been followed for at least 2 years. ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: From registration to date of failure (local, regional, or distant progression, or second primary or death) or last follow-up. Analysis occurs after patients have been followed for at least 2 years. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after patients have been followed for at least 2 years. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

OBJECTIVES:

  • Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck.
  • Determine the disease-free and overall survival of patients treated with this regimen.
  • Determine the acute and chronic toxicity of this regimen in these patients.
  • Determine the patterns of failure in patients treated with this regimen.

OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5 weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: cisplatin
  • Drug: paclitaxel
  • Procedure: conventional surgery
  • Radiation: radiation therapy
Experimental: Surgery, chemotherapy and radiation therapy
Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
Interventions:
  • Drug: cisplatin
  • Drug: paclitaxel
  • Procedure: conventional surgery
  • Radiation: radiation therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
June 2010
February 2004   (final data collection date for primary outcome measure)

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 Characteristics
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00011999
RTOG-H-0024, CDR0000068469
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Randal S. Weber, MD Abramson Cancer Center of the University of Pennsylvania
Radiation Therapy Oncology Group
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP