Know Cancer

or
forgot password

Phase III Randomized Comparison of Radiotherapy Fractionation in Advanced Squamous Cell Carcinoma of the Head and Neck: Twice-Daily Hyperfractionation vs Split-Course Accelerated Hyperfractionation vs Accelerated Fractionation With Concomitant Boost vs Standard Fractionation


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

Phase III Randomized Comparison of Radiotherapy Fractionation in Advanced Squamous Cell Carcinoma of the Head and Neck: Twice-Daily Hyperfractionation vs Split-Course Accelerated Hyperfractionation vs Accelerated Fractionation With Concomitant Boost vs Standard Fractionation


OBJECTIVES: I. Determine whether hyperfractionation and/or accelerated fractionation
(split-course or with a concomitant boost) improves the locoregional control rate over
standard fractionation radiotherapy in patients with advanced squamous cell carcinomas of
the head and neck. II. Determine the disease-free survival and overall survival of these
patients treated with different radiotherapy fractionation schemes. III. Determine the acute
and late toxicities of each fractionation schedule. IV. Compare the quality of life on the
two regimens.

OUTLINE: Randomized study. Arm I: Radiotherapy. Irradiation of primary tumor and involved
and at-risk nodal areas using linear accelerators with photon energies of 1.25-6.0 MV (dual
energy arrangements may also use a beam greater than 6.0 MV), electrons of 4-25 MV, or Co60.
Standard fractionation. Arm II: Radiotherapy. Targets and equipment as in Arm I.
Hyperfractionation. Arm III: Radiotherapy. Targets and equipment as in Arm I. Accelerated
split-course hyperfractionation. Arm IV: Radiotherapy. Targets and equipment as in Arm I.
Accelerated fractionation with concomitant boost.

PROJECTED ACCRUAL: A total of 1,080 patients (270/arm) will be accrued over 5.75 years. If
excessive toxicity is noted in any arm after entry of 324 and 634 patients, that arm may be
closed.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and
neck, including lymphoepithelioma and anaplastic carcinoma Biopsy from the primary or
regional nodes acceptable No adenocarcinomas The following stages and sites are eligible:
Stage III/IV oral cavity, including: Anterior 2/3 of the tongue Buccal mucosa Floor of
mouth Hard palate Gingiva Retromolar trigone Stage III/IV oropharynx, including: Tonsil
and pillars Faucial arch and soft palate Posterolateral pharyngeal walls Stage II/III/IV
base of the tongue and hypopharynx Stage III/IV supraglottic larynx, including:
Ventricular band Arytenoid Supra- and infrahyoid epiglottis Aryepiglottic fold (tumors at
glottic and subglottic sites excluded) Nonpalpable nodes detected only on CT or MRI must
be at least 1.0 cm in diameter or contain necrosis to prove N+ disease No metastasis below
the clavicle clinically or radiologically

PATIENT CHARACTERISTICS: Age: At least 18 Performance status: Karnofsky 60-100%
Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Medically
able to withstand radiotherapy No second malignancy within 5 years except nonmelanomatous
skin cancer Follow-up by participating radiotherapist required

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head
and neck No planned combined external beam and interstitial boost irradiation Surgery: No
prior surgery (other than biopsy) No planned combined pre- or postoperative programs
Radical neck dissections allowed if lymph nodes are greater than 3 cm prior to
radiotherapy or involvement persists after treatment Resection of persistent disease at
the primary site may be performed 6 weeks after completion of radiotherapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

K. Kian Ang, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000076475

NCT ID:

NCT00771641

Start Date:

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the oropharynx
  • stage II lymphoepithelioma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • stage II squamous cell carcinoma of the hypopharynx
  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location