Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer That Has Been Removed During Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	RTOG-9501 E-R9501, SWOG-9515, NCT00002670, RTOG-95-01

Objectives

I.  Evaluate locoregional control rates, patterns of first failure, and 
overall and disease-free survival in patients with advanced squamous cell 
carcinoma of the head and neck at high risk of locoregional recurrence who are 
treated postoperatively with concurrent cisplatin and radiotherapy.

II.  Compare the toxicity of concurrent chemoradiotherapy vs. radiotherapy 
alone in the postoperative setting.

Entry Criteria

Disease Characteristics:

Biopsy-proven squamous cell carcinoma of one of the following sites:
  Hypopharynx
  Larynx
  Oral cavity
  Oropharynx

At least 1 of the following high-risk factors required:
  Histologic extracapsular nodal extension
  Histologic involvement of 2 or more regional lymph nodes
  Microscopically positive mucosal margins

Complete resection of all visible and palpable disease
  Therapy must begin within 8 weeks of tumor-related surgery
  Bilateral resections may or may not be performed simultaneously
     Eligibility window begins with first definitive surgery
  Neck dissection not required for T4 N0, truly midline supraglottic tumors

No tumors of the lip, nasopharynx, or sinuses

No synchronous or concurrent head and neck tumors

No evidence of distant metastasis

Concurrent registration on Fixed Tumor Repository Study allowed

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy 

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy to head and neck region

Surgery:
  See Disease Characteristics

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 60%-100%

Hematopoietic:
  WBC at least 3,500
  Platelets at least 100,000

Hepatic:
  Not specified

Renal:
  Creatinine clearance greater than 50 mL/min

Other:
  No medical contraindication to protocol therapy
  No second malignancy within 5 years
  No pregnant or nursing women

Expected Enrollment

438 patients will be entered over approximately 5 years.

Outline

Randomized study.

Arm I:  Radiotherapy.  Involved-field irradiation using Co60, 1-6 MV photons, 
or electrons.

Arm II:  Radiotherapy plus Single-Agent Chemotherapy.  Irradiation as in Arm 
I; plus Cisplatin, CDDP, NSC-119875.

Cooper JS, Pajak TF, Forastiere AA, et al.: Long-term survival results of a phase III intergroup trial (RTOG 95-01) of surgery followed by radiotherapy vs. radiochemotherapy for resectable high risk squamous cell carcinoma of the head and neck. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-25, S14-5, 2006.

Cooper JS, Pajak TF, Forastiere AA, et al.: Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med 350 (19): 1937-44, 2004.[PUBMED Abstract]

Cooper JS, Pajak TF, Forastiere AA, et al.: Postoperative concurrent radiochemotherapy in high-risk SCCA of the head and neck: initial report of RTOG 9501/intergroup phase III trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-903, 2002.

Cooper JS, Pajak TF, Forastiere AA, et al.: Patterns of failure for resected advanced head & neck cancer treated by concurrent chemotherapy and radiation therapy: an analysis of RTOG 9501/intergroup phase III trial. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): 2, 2002.

Cullen KJ, Nikitakis N, Goloubeva O, et al.: Effect of elevated expression of GST-π and p53 on prognosis in head and neck cancer patients treated with chemoradiotherapy but not radiotherapy alone: An analysis of RTOG trials 9003 and 9501. [Abstract] J Clin Oncol 26 (Suppl 15): A-6013, 2008.

Schumaker L, Nikitakis N, Goloubeva O, et al.: Elevated expression of glutathione S-transferase pi and p53 confers poor prognosis in head and neck cancer patients treated with chemoradiotherapy but not radiotherapy alone. Clin Cancer Res 14 (18): 5877-83, 2008.[PUBMED Abstract]

Bernier J, Cooper JS, Pajak TF, et al.: Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck 27 (10): 843-50, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Jay Cooper, MD, FACR, FACRO, Protocol chair(Contact information may not be current)		Ph: 212-263-6485 Email: jay.cooper@med.nyu.edu

Eastern Cooperative Oncology Group

James Endicott, MD, PA, Protocol chair(Contact information may not be current)		Ph: 813-745-4261; 888-663-3488

Southwest Oncology Group

Julie Kish, MD, FACP, Protocol chair(Contact information may not be current)		Ph: 313-916-1850; 888-734-5322

Registry Information
Official Title		PHASE III INTERGROUP TRIAL OF SURGERY FOLLOWED BY (1) RADIOTHERAPY VS. (2) RADIOCHEMOTHERAPY FOR RESECTABLE HIGH RISK SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
Trial Start Date		1995-09-05
Registered in ClinicalTrials.gov		NCT00002670
Date Submitted to PDQ		1995-09-05
Information Last Verified		2008-09-22
NCI Grant/Contract Number		U10-CA21661

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