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
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Patient tolerance of the treatment regimen [ Time Frame: From registration to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: March 2001
Study Completion Date: June 2010
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: cisplatin Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011999

  Show 234 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Randal S. Weber, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
Publications:
Rosenthal DJ, Harris J, Forastiere AA, et al.: Early postoperative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy (RT) (phase II trial RTOG H-0024) is well tolerated for patients with resected, high-risk squamous carcinoma of the head and neck (HNSCC). [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-1111, S322, 2004.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00011999     History of Changes
Other Study ID Numbers: RTOG-H-0024, CDR0000068469
Study First Received: March 3, 2001
Last Updated: October 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 14, 2014