RADIATION THERAPY ONCOLOGY GROUP
0225
RTOG
A PHASE II STUDY OF INTENSITY MODULATED RADIATION THERAPY (IMRT) +/-
CHEMOTHERAPY FOR NASOPHARYNGEAL CANCER
Study Chairmen
Radiation Oncology Nancy Lee, M.D.
Sloan-Kettering
Memorial
Cancer Center
1275 York Avenue
Radiation Oncology Box #22
New York, NY 10021
212-639-3342
Fax: 212-794-3188
Garden,
M.D.
Adam
792-3400
713-
713-794-5573
Fax:
agarden@du
Medical Oncology Alan Kramer, M.D
415-885-8600
Fax:
415-885-8680
Medical Physics Ping Xia, Ph.D.
415-353-7194
Fax: 415-353-9883
xia@radonc17.ucsf.edu
Activation Date:February 21, 2003
22,
November
2005
Closure
Date:
Update Date: February 21, 2003
Version Date: May 26, 2005
Includes Amendments 1- 5
(Broadcast 6/16/05)
RTOG HQ/ Statistical Center
215-574-3189
800-227-5463 Ext. 4189
This protocol was designed and developed by the Radiation Therapy Oncology
Group (RTOG) of the American College of Radiology (ACR). It is intended to be
ud only in conjunction with institution-specific IRB approval for study entry.
No other u or reproduction is authorized by RTOG nor does RTOG assume
any responsibility for unauthorized u of this protocol.
INDEX
Schema
Check
Eligibility
1.0 Introduction
2.0 Objectives
3.0 Patient Selection
4.0 Pretreatment Evaluations
5.0 Registration Procedures
6.0 Radiation Therapy
7.0 Drug Therapy
8.0 Surgery
Therapy
9.0 Other
10.0 Pathology
Asssments
11.0 Patient
Collection
12.0 Data
13.0 References
Appendix I - Sample Connt Form
Appendix II - Performance Status
Appendix III - Staging System
Appendix IV - Toxicity Criteria
Appendix V - IMRT Quality Assurance Guidelines
Appendix VI - Management of Dental Problems
RADIATION THERAPY ONCOLOGY GROUP
RTOG0225
A PHASE II STUDY OF INTENSITY MODULATED RADIATION THERAPY (IMRT) +/-
CHEMOTHERAPY FOR NASOPHARYNGEAL CANCER
SCHEMA
Treatment Plan:
Planning target volumes (PTVs) of the primary tumor, lymph node metastas, lymph nodes at
risk
R of metastatic dia, critical organs and the major salivary glands will be outlined on planning CT scans. IMRT technique will be utilized. Gross dia PTV do will be 70 Gy / 33 fractions
E and subclinical PTV do, 59.4 Gy / 33 fractions. The major salivary glands will be spared
according to specified criteria (e Section 6.4.5). Saliva output will be measured before and
therapy.
G following
I Chemotherapy:
≥ T2b and/or node positive patients will receive chemotherapy concurrent with IMRT and Stage
S adjuvant following IMRT
T Concurrent with IMRT:
Cisplatin 100 mg/m2 I.V. on days 1, 22, and 43
E
Adjuvant following IMRT:
R 5-FU 1,000 mg/m2 per 24 hours as a 96 hour continuous infusion on days 71-74, 99-102, and 127- 130
Cisplatin 80 mg/m2 I.V. on days 71, 99, and 127
NOTE: Prophylactic u of amifostine and pilocarpine is not allowed (e Sections 3.2.9 and 9.0)
Eligibility: (See Section 3.0 for details) [7/6/04]
-Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO I-III, Stage I-IVB, requiring primary irradiation
-No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
-≥ 18 years of age
-Zubrod performance status 0-1
≥ 4,000/µl, platelets ≥ 100,000/µl; rum creatinine ≤ 1.6 mg/dl or 24 hr. calculated creatinine
- WBC
clearance ≥ 60 ml/min (e Section 3.1.6)
-Must undergo pre-treatment evaluation of tumor extent and tumor measurement
-Nutritional and general physical condition must be considered compatible with the propod radio-therapeutic treatment
-No prior radiotherapy to the head and neck or any prior chemotherapy ≤ 6 months prior to study entry
-No other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin ≤ 5 years -No evidence of distant metastasis
-Not on any other experimental therapeutic cancer treatment
-No active untreated infection
-No major medical or psychiatric illness
-No pregnant women if node positive or Stage ≥ T2b
-Signed study-specific connt form prior to study entry
Required Sample Size: 64
RTOG Institution #
RTOG 0225 ELIGIBILITY CHECKLIST (7/6/04)
Ca # (page 1 of 2)
(Y) 1. Is the primary tumor site arising from the nasopharynx?
(Y) 2. Is the confirmed histology squamous cell cancer?
the biopsy proven stage?
(I-IVB) 3. What
is
(Y/N) 4. Was there surgery on the primary tumor or lymph nodes?
________(Y) If yes, was surgery limited to incisional or excisional
biopsies?
(Y) 5. Is the patient ≥ 18 years of age?
6. What is the Zubrod performance status?
(Y) 7. Has the patient undergone pretreatment evaluation of tumor for extent and
measurement?
(N)8. Does the patient have any rious medical or psychiatric illness that would
preclude informed connt?
(N)9. Is the patient on any other therapeutic treatment for head and neck cancer?
(N)10. Is there evidence of distant metastas?
(N) 11. Did the patient have any previous irradiation for head and neck cancer ≤ 6
months prior to study entry?
(Y/N) 12. Is there planned concurrent chemotherapy? (except patients with node positive
and/or Stage ≥ T2b)?
(Y) 13. If node positive or Stage ≥ T2b, will the patient receive chemotherapy as per
Section 7.0 of the protocol?
_____________(N) 14. Has the patient received chemotherapy for any reason ≤ 6 months prior to study
entry?
(Y/N) 15. Any prior malignancy (other than non-melanomatous skin cancer)?
If yes, has the patient been continuously dia-free for ≥ 5
years ?
(N) 16. Does the patient have an active, untreated infection ?
(N) 17. Has the patient taken amifostine or pilocarpine prophylactically ?
(Y) 18. Have all pretreatment studies in Section 4.0 been obtained in the time frame
indicated ?
(Y) 19. Is the WBC ≥ 4,000/mm3 ?
(Y) 20. Is the platelet count ≥ 100,00/mm3 ?
RTOG Institution #
RTOG 0225 ELIGIBILITY CHECKLIST (5/26/05)
Ca # (page 2 of 2)
(Y) 21. Is the rum creatinine ≤ 1.6 mg/dl or 24 hour or calculated creatinine clearance
≥ 60 ml/min ? (e Section 3.1.6)
(Y) 22. Is your institution pre-approved for IMRT studies by the Image-Guided Therapy
Center (ITC) and the Radiological Physics Center ?
The following questions will be asked at Study Registration:
1. Name of institutional person registering this ca?
(Y) 2. Has the Eligibility Checklist (above) been completed?
(Y) 3. Is the patient eligible for this study?
4. Date the study-specific Connt Form was signed? (must be prior to study
entry)
Initials
5. Patient’s
Physician
6. Verifying
7. Patient’s ID Number
8. Date of Birth
Race
9.
10. Ethnic Category (Hispanic or Latino, Not Hispanic or Latino, Unknown)
11. Gender
12. Patient’s Country of Residence
Code
Zip
13.
14. Patient’s Insurance Status
15. Will any component of the patient’s care be given at a VA or military
hospital?
Oncologist
16.
Medical
17. Treatment Start Date
(Y/N) 18. Is patient Stage ≥ T2b and/or node positive?
The Eligibility Checklist must be completed in its entirety prior to web registration. The completed, signed, and dated checklist ud at study entry must be retained in the patient’s study file and will be evaluated during an institutional NCI/RTOG audit.
by Date
Completed
