Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 10/27/2018 |
| Start Date: | January 2010 |
| End Date: | January 2022 |
A Phase II Study on Treatment De-Intensification in Favorable Squamous Cell Carcinoma of the Oropharynx
This research is being done to try to reduce radiation side effects that happen with the
standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy
are standard treatment for people with squamous cell carcinoma of the oropharynx.
The study will look at giving a slightly smaller dose of radiation (de-intensification) to
see if regularly expected late toxicities (two years after receiving treatment) can be
reduced. This study will also try to see if the smaller dose of radiation is equally
effective at treating the cancer and to see if it improves quality of life. Along with this
radiation treatment plan some participants in this study will have surgery on their tumor and
or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy
will be up to the participant's doctor.
Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is
required for this study. Some studies have suggested that HPV-related cancer is biologically
and clinically different as compared to non-HPV-related cancer. Some studies have found that
patients with HPV-related oropharynx cancer have a better response to treatment. This test
will help researchers learn more about HPV-related cancer.
standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy
are standard treatment for people with squamous cell carcinoma of the oropharynx.
The study will look at giving a slightly smaller dose of radiation (de-intensification) to
see if regularly expected late toxicities (two years after receiving treatment) can be
reduced. This study will also try to see if the smaller dose of radiation is equally
effective at treating the cancer and to see if it improves quality of life. Along with this
radiation treatment plan some participants in this study will have surgery on their tumor and
or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy
will be up to the participant's doctor.
Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is
required for this study. Some studies have suggested that HPV-related cancer is biologically
and clinically different as compared to non-HPV-related cancer. Some studies have found that
patients with HPV-related oropharynx cancer have a better response to treatment. This test
will help researchers learn more about HPV-related cancer.
Inclusion Criteria:
- Biopsy-proven SCC of the oropharynx (tonsil, base of tongue, pharyngeal wall or
palate).
- Tumor positive for infection with human papilloma virus (HPV) virus.
- T stage: 1, 2 or T3. Surgery of the primary tumor is limited to incisional or
excisional biopsies (i.e tonsillectomy) even without macroscopic disease left.
Positive resection margins and/or gross residual disease at the primary site are
allowed.
- Any N stage, but resectable; lymph nodes in both sides of the neck are at risk of
metastatic disease, according to clinical judgment, and require irradiation;
pretreatment surgery in the neck in the forms of incisional/excisional biopsy or a
multilevel neck dissection is allowed only if there is gross tumor left at the primary
site.
- No other malignancy except for non-myelomatous skin cancer, early stage prostate
cancer (T<2a and PSA<10 and GLS<7) or a carcinoma not of head and neck origin disease
free for > 5 yrs.
- Cannot have distant metastasis (M0)
- ECOG performance status 0-1.
- Patient's nutritional and general physical condition must be considered compatible
with the proposed radiotherapeutic treatment.
- Patient is judged to be mentally reliable to follow instructions and to keep
appointments.
- Patient is on no other treatment for head and neck cancer.
- Signed study-specific informed consent prior to registration.
Exclusion Criteria:
- Evidence of distant metastases.
- Absence of macroscopic disease after upfront surgery
- Previous irradiation for head and neck tumor; concurrent chemotherapy other than the
treatment per protocol; previous chemotherapy ≤ 3 months from start of RT.
- Active untreated infection.
- Major medical or psychiatric illness, which in the investigators' opinions would
interfere with either completion of therapy and follow-up or with full and complete
understanding of the risks and potential complications of the therapy.
- Prophylactic use of amifostine or pilocarpine is not allowed.
- Patients with greater than 1- pack years of smoking history and/or currently a smoker
at the time of treatment
We found this trial at
1
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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