Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/23/2018 |
| Start Date: | October 2006 |
| End Date: | December 2019 |
A Phase II Study of Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
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
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
- Before beginning study treatment, participants will be asked to fill out a Quality of
Life (QOL) questionnaires, a Speech Assessment, a ChemoSensory Questionnaire, a Patient
Swallowing Diary, A Swallowing Study, Salivary Tests and a Trismus Assessment.
Participants will need to go to the Massachusetts Eye and Ear Infirmary (MEEI) or
Massachusetts General Hospital (MGH) for these tests.
- Radiation therapy will be given once a day, five days a week, for seven weeks. This will
be given as outpatient care at the Northeast Proton Therapy Center (proton component)
and Massachusetts General Hospital (photon component).
- During radiation treatments, participants will receive cisplatin intravenously once
every three weeks. This three-week period is called a cycle of treatment.
- After the completion of radiation, participants will receive cisplatin intravenously
once every 4 weeks along with fluorouracil as a continuous infusion over 4 days starting
on the day cisplatin is given, for three cycles.
- Participants will have a physical exam and blood work drawn weekly to monitor their
health.
- An MR/CT scan of the head and neck will be done 2 months after the radiation treatment.
- Follow-up visits will occur once every three months for 2 years, then once every 6
months during years 3-5, then annually. During these follow-up visits, participants will
have the following tests and procedures: physical examination; blood work; chest CT scan
and CT/MRI of the head and neck will be repeated once every 6 months during the first
three years; swallow study; salivary study; QOL questionnaires; speech assessment;
ChemoSensory Questionnaire; and Trismus Assessment.
Life (QOL) questionnaires, a Speech Assessment, a ChemoSensory Questionnaire, a Patient
Swallowing Diary, A Swallowing Study, Salivary Tests and a Trismus Assessment.
Participants will need to go to the Massachusetts Eye and Ear Infirmary (MEEI) or
Massachusetts General Hospital (MGH) for these tests.
- Radiation therapy will be given once a day, five days a week, for seven weeks. This will
be given as outpatient care at the Northeast Proton Therapy Center (proton component)
and Massachusetts General Hospital (photon component).
- During radiation treatments, participants will receive cisplatin intravenously once
every three weeks. This three-week period is called a cycle of treatment.
- After the completion of radiation, participants will receive cisplatin intravenously
once every 4 weeks along with fluorouracil as a continuous infusion over 4 days starting
on the day cisplatin is given, for three cycles.
- Participants will have a physical exam and blood work drawn weekly to monitor their
health.
- An MR/CT scan of the head and neck will be done 2 months after the radiation treatment.
- Follow-up visits will occur once every three months for 2 years, then once every 6
months during years 3-5, then annually. During these follow-up visits, participants will
have the following tests and procedures: physical examination; blood work; chest CT scan
and CT/MRI of the head and neck will be repeated once every 6 months during the first
three years; swallow study; salivary study; QOL questionnaires; speech assessment;
ChemoSensory Questionnaire; and Trismus Assessment.
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
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