Phase 2
N=25
Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00592501 ↗Enrolled (actual)
25
Serious AEs
4.4%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants With Acute Toxicity — 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Proton/Photon Radiotherapy (Radiation); Cisplatin (Drug); Fluorouracil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Toxicity |
23 | — |
| PRIMARY Participant Compliance Rate to Assigned Treatment Intervention |
100; 75; 83 | — |
| PRIMARY Sialometry to Evaluate Xerostomia (Dry Mouth) |
1.89; 0.95 | — |
| PRIMARY Penetration-aspiration Scale to Evaluate Swallowing Function |
1.04; 1.36 | — |
| PRIMARY Serial Measurements of Maximal Inter-incisal Distance to Evaluate Trismus (Lockjaw) |
51.4; 43.8 | — |
| PRIMARY ChemoSensory Questionnaire (CSQ) to Evaluate Smell and Taste Function |
17; 18 | — |
| PRIMARY Number of Participants With Speech Problems Assessed by Head and Neck Health Status Assessment Inventory (HNHSAI) |
— | — |
| PRIMARY Health Related Quality-of-Life Outcomes Using Validated Quality-of-Life Instrument EORTC QLQ-C30 |
83 | — |
| PRIMARY Health Related Quality-of-life Outcomes Using Validated Quality-of-life Instrument EORTC-QLQ-H&N |
11.4 | — |
| SECONDARY Rate and Pattern of Locoregional Tumor Recurrence |
2; 3 | — |
Summary
Photon beam radiation is the standard type of radiation used to treat nasopharyngeal carcinoma. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor and leaves the body through healthy tissue. Proton beam radiation has been shown to have the same effect on tumors as photon beam radiation but it enters the body, passes through healthy tissue, and encounters the tumor but then stops. This means less healthy tissue is affected by proton beam treatment than by photon beam treatment. The purpose of this study is to determine the effectiveness of proton beam radiation in treating nasopharyngeal cancer and reducing the acute and long-term side effects from the treatment. This study will also test to see if the sparing of the healthy tissue can improve quality of life
Eligibility Criteria
Inclusion Criteria
- Biopsy proven greater than or equal to T2b and/or node positive non-metastatic, squamous cell carcinoma of the nasopharynx, types WHO I-III.
- No head and neck surgery of the primary tumor or lymph nodes except incisional or excisional biopsies.
- Zubrod performance status 0-1 or Karnofsky 70 or above.
- All patients must undergo pre-treatment evaluation of tumor extent and tumor measurement.
- Nutritional and general physical condition must be considered compatible with the proposed chemoradiation treatment
- Patients must have adequate platelet and renal function as outlined in protocol.
- 18 years of age or above.
- No active alcohol addiction.
- Women of childbearing potential must have a negative pregnancy test.
Exclusion Criteria
- Stage IVC or evidence of distant metastases
- Previous irradiation for head and neck tumor
- Patient is on other experimental therapeutic cancer treatment
- Other malignancy except non-melanoma skin cancer or carcinomas of head and neck origin and have been controlled for at least 5 years.
- Active untreated infection
- Major medical or psychiatric illness
- Prophylactic use of amifostine or pilocarpine
- Pregnant or breast feeding women
- Symptomatic peripheral neuropathy of grade 2 or greater by NCI CTCAE
- Symptomatic altered hearing > grade 2 by CTCAE
Data sourced from ClinicalTrials.gov (NCT00592501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.