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NCT00771641 · CITED IN SOURCE DOCUMENTS

Fractionated Radiation Therapy in Treating Advanced Squamous Cell Carcinoma of the Head and Neck

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2014-01-24

RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Standard Fractionation: 2 Gy/Fx, Q.D. 5 Days/wk, Total Dose: 70 Gy/35 Fx x 7 wks
    intervention Names
    1. Procedure: conventional surgery
    2. Radiation: low-LET cobalt-60 gamma ray therapy
    3. Radiation: low-LET electron therapy
    4. Radiation: low-LET photon therapy
    5. Radiation: radiation therapy
    label
    Standard Fractionation
    type
    ACTIVE_COMPARATOR
  2. description
    Hyperfractionation: 1.2 Gy/Fx, b.i.d. (\> 6 hours apart, 5 days/wk) Total Dose: 81.6 Gy/68 Fx/7 weeks
    intervention Names
    1. Procedure: conventional surgery
    2. Radiation: low-LET cobalt-60 gamma ray therapy
    3. Radiation: low-LET electron therapy
    4. Radiation: low-LET photon therapy
    5. Radiation: radiation therapy
    label
    Hyperfractionation
    type
    EXPERIMENTAL
  3. description
    Accelerated Hyperfractionation with split: 1.6 Gy/Fx b.i.d. (\> 6 hours apart), 5 days/wk, Total Dose: 67.2 Gy/42 Fx/6 wks with a 2 week rest after 38.4 Gy
    intervention Names
    1. Procedure: conventional surgery
    2. Radiation: low-LET cobalt-60 gamma ray therapy
    3. Radiation: low-LET electron therapy
    4. Radiation: low-LET photon therapy
    5. Radiation: radiation therapy
    label
    Accelerated Hyperfractionation with split
    type
    EXPERIMENTAL
  4. description
    Accelerated fractionation with concomitant boost
    intervention Names
    1. Procedure: conventional surgery
    2. Radiation: low-LET cobalt-60 gamma ray therapy
    3. Radiation: low-LET electron therapy
    4. Radiation: low-LET photon therapy
    5. Radiation: radiation therapy
    label
    Accelerated fractionation with concomitant boost
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Accelerated Hyperfractionation with split
    2. Accelerated fractionation with concomitant boost
    3. Hyperfractionation
    4. Standard Fractionation
    name
    conventional surgery
    type
    PROCEDURE
  2. arm Group Labels
    1. Accelerated Hyperfractionation with split
    2. Accelerated fractionation with concomitant boost
    3. Hyperfractionation
    4. Standard Fractionation
    name
    low-LET cobalt-60 gamma ray therapy
    type
    RADIATION
  3. arm Group Labels
    1. Accelerated Hyperfractionation with split
    2. Accelerated fractionation with concomitant boost
    3. Hyperfractionation
    4. Standard Fractionation
    name
    low-LET electron therapy
    type
    RADIATION
  4. arm Group Labels
    1. Accelerated Hyperfractionation with split
    2. Accelerated fractionation with concomitant boost
    3. Hyperfractionation
    4. Standard Fractionation
    name
    low-LET photon therapy
    type
    RADIATION
  5. arm Group Labels
    1. Accelerated Hyperfractionation with split
    2. Accelerated fractionation with concomitant boost
    3. Hyperfractionation
    4. Standard Fractionation
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1113
type
ACTUAL
Registered outcome plans (not posted results)
Full study description
brief Summary
RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available
detailed Description
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.
Source references
references
  1. citation
    Gillison ML, Zhang Q, Jordan R, Xiao W, Westra WH, Trotti A, Spencer S, Harris J, Chung CH, Ang KK. Tobacco smoking and increased risk of death and progression for patients with p16-positive and p16-negative oropharyngeal cancer. J Clin Oncol. 2012 Jun 10;30(17):2102-11. doi: 10.1200/JCO.2011.38.4099. Epub 2012 May 7.
    pmid
    22565003
    type
    BACKGROUND
  2. citation
    Dilling TJ, Bae K, Paulus R, Watkins-Bruner D, Garden AS, Forastiere A, Kian Ang K, Movsas B. Impact of gender, partner status, and race on locoregional failure and overall survival in head and neck cancer patients in three radiation therapy oncology group trials. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):e101-9. doi: 10.1016/j.ijrobp.2011.01.013. Epub 2011 May 5.
    pmid
    21549515
    type
    BACKGROUND
  3. citation
    Coyne JC, Pajak TF, Harris J, Konski A, Movsas B, Ang K, Watkins Bruner D; Radiation Therapy Oncology Group. Emotional well-being does not predict survival in head and neck cancer patients: a Radiation Therapy Oncology Group study. Cancer. 2007 Dec 1;110(11):2568-75. doi: 10.1002/cncr.23080.
    pmid
    17955501
    type
    BACKGROUND
  4. citation
    Schumaker L, Nikitakis N, Goloubeva O, Tan M, Taylor R, Cullen KJ. 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. 2008 Sep 15;14(18):5877-83. doi: 10.1158/1078-0432.CCR-08-0998.
    pmid
    18794100
    type
    BACKGROUND
  5. citation
    Siddiqui F, Pajak TF, Watkins-Bruner D, Konski AA, Coyne JC, Gwede CK, Garden AS, Spencer SA, Jones C, Movsas B. Pretreatment quality of life predicts for locoregional control in head and neck cancer patients: a radiation therapy oncology group analysis. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):353-60. doi: 10.1016/j.ijrobp.2007.06.024. Epub 2007 Sep 24.
    pmid
    17889449
    type
    BACKGROUND
  6. citation
    Spiegel D, Kraemer HC. Emotional well-being does not predict survival in head and neck cancer patients: a Radiation Therapy Oncology Group study. Cancer. 2008 May 15;112(10):2326-7; author reply 2327-8. doi: 10.1002/cncr.23435. No abstract available.
    pmid
    18338746
    type
    BACKGROUND
  7. citation
    Sanabria A, Carvalho AL, Kowalski LP. Is nutrition support related to a poor prognosis in head and neck cancer patients? Thoughts about the secondary analysis of RTOG trial 90-03. Head Neck. 2007 May;29(5):518-9; author reply 519-20. doi: 10.1002/hed.20617. No abstract available.
    pmid
    17390379
    type
    BACKGROUND
  8. citation
    Konski AA, Pajak T, Movsas B, et al.: Socio-demographic variables influence outcome in Radiation Therapy Oncology Group head and neck trials. [Abstract] Proceedings of the American Society of Clinical Oncology 22 (Suppl 14): A-6043, 529s, 2004.
    type
    BACKGROUND
  9. citation
    Kumar P, Harris J, Garden AS, et al.: Outcome comparisons of four Radiation Therapy Oncology Group (RTOG) trials in patients with stage IV-T4 head and neck (H/N) cancer: encouraging results using intra-arterial (IA) cisplatin (P) and concurrent radiation therapy (RT). [Abstract] J Clin Oncol 22 (Suppl 14): A-5527, 494s, 2004.
    type
    BACKGROUND
  10. citation
    Movsas B, Konski A, Pajak T, et al.: Quality of life (QOL) variables influence local regional control in Radiation Therapy Oncology Group (RTOG) headsneck trials (9003 and 9111). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-199, S252, 2004.
    type
    BACKGROUND
  11. citation
    Owen JB, Grigsby PW, Caldwell TM, Konski AA, Johnson DJ, Demas WF, Movsas B, Jones CU, Wasserman TH. Can costs be measured and predicted by modeling within a cooperative clinical trials group? Economic methodologic pilot studies of the radiation therapy oncology group (RTOG) studies 90-03 and 91-04. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):633-9. doi: 10.1016/s0360-3016(00)00770-7.
    pmid
    11172943
    type
    BACKGROUND
  12. citation
    Chung CH, Dignam JJ, Hammond ME, Klimowicz AC, Petrillo SK, Magliocco A, Jordan R, Trotti A, Spencer S, Cooper JS, Le QT, Ang KK. Glioma-associated oncogene family zinc finger 1 expression and metastasis in patients with head and neck squamous cell carcinoma treated with radiation therapy (RTOG 9003). J Clin Oncol. 2011 Apr 1;29(10):1326-34. doi: 10.1200/JCO.2010.32.3295. Epub 2011 Feb 28.
    pmid
    21357786
    type
    RESULT
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    Preserved source evidence · Not medical advice