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A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors



- Determine the feasibility of conducting a cooperative group prospective clinical trial
in patients with resected malignant salivary gland tumors.

- Acquire preliminary efficacy data comparing postoperative radiotherapy alone to
concurrent chemotherapy and radiation using weekly cisplatin.


- Compare the acute toxicities of these 2 adjuvant treatments.

- Compare long-term efficacy results at 5 years and late treatment-related adverse events
in patients receiving postoperative radiation to those receiving concurrent

- Investigate quality of life and patient-reported outcomes in patients enrolled in the

- Identify the histopathology and tumor marker expression from patients enrolled on this
trial and assemble a tissue bank for future correlative studies.

- Establish a Radiation Therapy Oncology Group (RTOG) baseline database for salivary
gland malignancies to serve as a resource for future exploration of innovative and/or
targeted approaches for this disease.

OUTLINE: This is a multicenter study. Patients are stratified according to histology
(high-grade mucoepidermoid carcinoma vs salivary duct carcinoma vs high-grade
adenocarcinoma) and nodal status (N0 vs N1-3). Patients are randomized to 1 of 2 treatment

- Arm I: Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or
intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also
receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during

- Arm II: Patients undergo 3D-CRT or IMRT as in arm I. Tissue and blood samples may be
collected for translational research studies. Patients may complete quality-of-life
assessments periodically.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, and 24 months,
every 6 months for 2 years, and then annually thereafter.

Inclusion Criteria


- Pathologically proven diagnosis of a malignant major salivary gland tumor of the
following histologic subtypes:

- High-grade mucoepidermoid carcinoma

- Salivary duct carcinoma

- High-grade adenocarcinoma

- Surgical resection with curative intent within 8 weeks prior to registration

- All patients must have a Medical Oncology evaluation within 4 weeks prior to

- Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 1mm) or microscopically
positive surgical margin; patients must be free of distant metastases based upon the
following minimum diagnostic workup:

- History/physical examination within 8 weeks prior to registration

- Radiologic confirmation of the absence of hematogenous metastasis within 12
weeks prior to registration; at a minimum, contrast CT imaging of the chest is
required (PET/CT is acceptable)

- No patients with residual macroscopic disease after surgery

- No patients with salivary gland malignancies originating from the minor salivary

- No patients with histologies other than high-grade mucoepidermoid carcinoma,
high-grade adenocarcinoma, or salivary duct carcinoma


- Zubrod performance status 0-1

- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3

- Platelets ≥ 100,000 cells/mm^3

- Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve
hemoglobin ≥ 8.0 g/dL is acceptable)

- Serum creatinine < 2.0 mg/dL

- Total bilirubin < 2 x the institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the
institutional ULN

- Negative serum pregnancy test within 2 weeks prior to registration for women of
childbearing potential

- Women of childbearing potential and male participants who are sexually active must
practice adequate contraception during treatment and for 6 weeks following treatment

- Not pregnant or nursing

- Patients must be deemed able to comply with the treatment plan and follow-up schedule

- Patients must provide study specific informed consent prior to study entry, including
consent for mandatory tissue submission for central review

- No prior invasive malignancy (except non-melanomatous skin cancer) unless disease
free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral
cavity, or cervix are all permissible)

- No severe, active co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
(coagulation parameters are not required for entry into this protocol)

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for
Disease Control (CDC) definition (HIV testing is not required for entry into
this protocol)

- Protocol-specific requirements may also exclude immunocompromised patients

- Pre-existing ≥ grade 2 neuropathy

- No significant pre-existing hearing loss, as defined by the patient or treating


- See Disease Characteristics

- No prior systemic chemotherapy or radiation therapy for salivary gland malignancy
(prior chemotherapy for a different cancer is allowable)

- No prior radiotherapy to the region of the study cancer that would result in overlap
of radiation therapy fields

- No prior organ transplant

- No concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during

- No concurrent erythropoiesis-stimulating agents

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years

Outcome Time Frame:

From randomization to 2 years.

Safety Issue:


Principal Investigator

Cristina P. Rodriguez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Federal Government

Study ID:

RTOG 1008



Start Date:

January 2011

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage I salivary gland cancer
  • stage II salivary gland cancer
  • stage III salivary gland cancer
  • high-grade salivary gland mucoepidermoid carcinoma
  • salivary gland adenocarcinoma
  • stage IVA salivary gland cancer
  • stage IVB salivary gland cancer
  • stage IVC salivary gland cancer
  • Head and Neck Neoplasms
  • Salivary Gland Neoplasms



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