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Head and Neck CancerPhase 3NCT00002670

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

A Phase 3 study testing chemotherapy, cisplatin and low-LET cobalt-60 gamma ray therapy in people with Head and Neck Cancer, run by Radiation Therapy Oncology Group at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
chemotherapy, cisplatin and low-LET cobalt-60 gamma ray therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
459 participants
Where
23 sitesin 2 countries
Study dates
Sep 1995to Nov 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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

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

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

United States22 sites

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Veterans Affairs Medical Center - Nashville

    Nashville, Tennessee, 37212

  • Vanderbilt Cancer Center

    Nashville, Tennessee, 37232-6838

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - Sooner State

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

Other trials in United States

South Africa1 site

  • Pretoria Academic Hospital

    Pretoria, 0001

Other trials in South Africa

About this study

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

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy plus cisplatin is more effective than radiation therapy alone in treating patients with head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with head and neck cancer that has been removed during surgery.

Read the detailed description

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.

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.

PROJECTED ACCRUAL: 438 patients will be entered over approximately 5 years.

Being tested
chemotherapy, cisplatin, low-LET cobalt-60 gamma ray therapy, low-LET electron therapy, low-LET photon therapy
Keywords
stage II squamous cell carcinoma of the lip and oral cavity, 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 III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma 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 II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chemotherapyDrug

  • cisplatinDrug

  • low-LET cobalt-60 gamma ray therapyRadiation

  • low-LET electron therapyRadiation

  • low-LET photon therapyRadiation

Study groups in NCT00002670
Study groupRoleWhat they receive
Radiation therapyActive comparatorRadiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week)
Receives: Radiation: low-LET cobalt-60 gamma ray therapy; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy
Radiation therapy plus cisplatinExperimentalRadiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week) plus Cisplatin-100 mg/m2 i.v. on days 1,22 and 43 with radiation therapy.
Receives: Drug: chemotherapy; Drug: cisplatin; Radiation: low-LET cobalt-60 gamma ray therapy; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2004 (estimated)
  2. Study startSep 1995
  3. Primary completionJul 2002
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002670
Sponsor's protocol ID
RTOG-9501
Other IDs
CDR0000064279, E-R9501, SWOG-9515
Status last verified
Jan 2014
First submitted
1 Nov 1999
Last updated
24 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18794100

  • Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefebvre JL. 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. 2005 Oct;27(10):843-50. doi: 10.1002/hed.20279.

    PubMed 16161069

  • Cooper JS, Zhang Q, Pajak TF, Forastiere AA, Jacobs J, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Lustig R, Ensley JF, Thorstad W, Schultz CJ, Yom SS, Ang KK. Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1198-205. doi: 10.1016/j.ijrobp.2012.05.008. Epub 2012 Jun 30.

    PubMed 22749632

  • 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, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.

    PubMed 15128893

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing chemotherapy, cisplatin and low-LET cobalt-60 gamma ray therapy in people with Head and Neck Cancer, run by Radiation Therapy Oncology Group at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002670, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.

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