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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by King Faisal Specialist Hospital & Research Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01488838
First received: December 7, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

A Randomized Phase II study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation alone in Resected High-Risk Malignant Salivary Gland Tumors


Condition Intervention Phase
Malignant Salivary Gland Tumors
Drug: Cisplatin: 40 mg/m2 weekly during radiation
Radiation: Radiation: 60-66 Gy in 2 Gy daily fractions
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1:
Radiation: 60-66 Gy in 2 Gy daily fractions Cisplatin: 40 mg/m2 weekly during radiation for 7 doses
Drug: Cisplatin: 40 mg/m2 weekly during radiation
Cisplatin: 40 mg/m2 weekly during radiation for 7 doses
Active Comparator: Arm 2:
Radiation: 60-66 Gy in 2 Gy daily fractions
Radiation: Radiation: 60-66 Gy in 2 Gy daily fractions
Radiation: 60-66 Gy in 2 Gy daily fractions

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically proven diagnosis of a malignant major salivary gland tumor of the following histologic subtypes: high grade mucoepidermoid carcinoma, salivary duct carcinoma or high grade adenocarcinoma;
  2. Surgical resection with curative intent within 8 weeks prior to registration;
  3. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤1mm) or microscopically positive surgical margin (AJCC, 7th ed.; see Appendix IV); patients must be free of distant metastases based upon the following minimum diagnostic workup:
  4. Zubrod Performance Status 0-1; 3.1.5 Age ≥ 18; 3.1.6 CBC/differential obtained within 4 weeks prior to registration, with adequate bone marrow function 3.1.7 Adequate renal and hepatic function within 4 weeks prior to registration 3.1.8 Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; 3.1.9 Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment. 3.1.10 Patients must be deemed able to comply with the treatment plan and follow-up schedule.

Exclusion Criteria:

3.2.1 Patients with residual macroscopic disease after surgery; 3.2.2 Patients with salivary gland malignancies originating from the minor salivary glands; 3.2.3 Patients with histologies other than high grade mucoepidermoid carcinoma, high grade adenocarcinoma or salivary duct carcinoma; 3.2.4 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); 3.2.5 Prior systemic chemotherapy or radiation therapy for salivary gland malignancy; note that prior chemotherapy for a different cancer is allowable; 3.2.6 Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; 3.2.7 Severe, active co-morbidity, defined as follows: 3.2.7.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; 3.2.7.2 Transmural myocardial infarction within the last 6 months; 3.2.7.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; 3.2.7.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; 3.2.7.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol. 3.2.7.6 Acquired Immune Deficiency Syndrome (AIDS) 3.2.7.7 Pre-existing ≥ grade 2 neuropathy; 3.2.7.8 Prior organ transplant. 3.2.8 Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary; 3.2.9 Significant pre-existing hearing loss, as defined by the patient or treating physician.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488838

Locations
Saudi Arabia
King Faisal Specialist Hospital& Research Center Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Nasser AlRajhi, MD    966-1-442-24575    nrajhi@kfshrc.edu.sa   
Contact: Fazal Hussain, MD    966-1-4423949    fhussain@kfshrc.edu.sa   
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Radiation Therapy Oncology Group
  More Information

No publications provided

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01488838     History of Changes
Other Study ID Numbers: 2111-096
Study First Received: December 7, 2011
Last Updated: December 7, 2011
Health Authority: Saudi Arabia: Ethics Committee

Additional relevant MeSH terms:
Salivary Gland Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014