Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer

NCT01953952 | Withdrawn Phase 2

• 4 other identifiers: RTOG 1221NCI-2013-00939RTOG-1221U10CA021661
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.

Conditions

Stage III Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Tongue Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Estimated for both arms using the Kaplan-Meier method. The distribution will be compared between arms with a one-sided log rank test.

  Up to 5 years

Secondary Outcomes (7)

• Patterns of local, regional, and distant failure

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Rate of grade 4-5 oropharyngeal hemorrhage and involved surgical margin for all patients and patients with selected T3 tumors

  Up to 5 years

• Objective swallowing function

  Up to 2 years

• Shoulder function

  Up to 2 years

Study Arms (2)

Arm I (surgery, risk-based adjuvant therapy)

EXPERIMENTAL

Patients undergo eHNS. Depending on post-operative pathology findings, patients may undergo IMRT QD five days a week for 6 weeks, beginning within 6 weeks after surgery. High-risk patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy.

Procedure: therapeutic conventional surgery; Radiation: intensity-modulated radiation therapy; Drug: cisplatin; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Arm II (chemoradiotherapy)

ACTIVE COMPARATOR

Patients undergo IMRT QD five days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy.

Radiation: intensity-modulated radiation therapy; Drug: cisplatin; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Interventions

therapeutic conventional surgery PROCEDURE

Undergo transoral eHNS

Arm I (surgery, risk-based adjuvant therapy)

intensity-modulated radiation therapy RADIATION

Undergo IMRT

Also known as: IMRT

Arm I (surgery, risk-based adjuvant therapy); Arm II (chemoradiotherapy)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Arm I (surgery, risk-based adjuvant therapy); Arm II (chemoradiotherapy)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (surgery, risk-based adjuvant therapy); Arm II (chemoradiotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (surgery, risk-based adjuvant therapy); Arm II (chemoradiotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, localized to the tonsil, glossopharyngeal sulcus, and tongue-base within 6 weeks (42 days) of registration
• The primary tumor must be resectable through a transoral endoscopic head and neck surgery with anticipation of resection free margins (resection does not require total or subtotal glossectomy or total laryngectomy); specifically, patients must (1) not have trismus, (2) not have interincisor opening less than 2.5 cm, and (3) not have poor transoral exposure of the tumor itself nor surrounding soft-tissue margins, regardless of etiology
• Clinical stage III-IV; T1-2, N1-2b; T3, N0-2b, with only well-lateralized exophytic T3 tumors not approaching within 1 cm of midline, and amenable to transoral eHNS
• p16 protein (p16) negative by immunohistochemistry (documented by the institution's pre-enrollment biomarker screening at a Clinical Laboratory Improvement Amendments \[CLIA\]-certified lab), defined as absent, weak, and/or only focal nuclear and cytoplasmic staining in less than 70% of the tumor cells
• Appropriate stage for protocol entry, including no distant metastases or adenopathy below the clavicles, based upon the following minimum diagnostic workup:
• History/physical examination by the treating physician (radiation oncologist, medical oncologist, or head and neck surgeon) within 30 days prior to registration
• Imaging of the head and neck (CT with contrast, positron emission tomography \[PET\]/CT, and/or magnetic resonance imaging \[MRI\]) within 30 days prior to registration; a CT scan with contrast is mandatory (unless contraindicated, e.g. contrast allergy, etc.); note that a PET/CT scan alone (unless performed with contrast) is not sufficient
• Chest CT scan (with or without contrast) or PET/CT of chest (with or without contrast) within 30 days prior to registration
• Modified barium swallow (MBS) to assess swallowing function within 30 days prior to registration
• Preoperative Mallampati assessment as documented by attending surgeon within 30 days prior to registration
• Zubrod performance status 0-1 within 30 days prior to registration
• Absolute neutrophil count (ANC) \>= 1,800 cells/mm\^3 based upon complete blood count (CBC)/differential
• Platelets \>= 100,000 cells/mm\^3 based upon CBC/differential
• Hemoglobin \>= 8.0 g/dl based upon CBC/differential (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
• Total bilirubin =\< 2 mg/dl

You may not qualify if:

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast or cervix are all permissible)
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Severe, active co-morbidity, defined as follows:
• \> 2 based on the American Society of Anesthesiologists (ASA) physical status classification system
• 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 within 30 days before registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immuno-compromised patients
• Prior allergic reaction to cisplatin
• Radiographic evidence of retropharyngeal metastasis

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (1)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Floyd C. Holsinger

  Radiation Therapy Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: December 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

US (1)