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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Natural history/Epidemiology, Treatment	Active	18 and over	Other	J-06109 NCT00414232

Trial Description

Summary

Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy.

Further Study Information

STUDY PLAN

1. Only the principal investigator, sub-investigators, and research nurse will be approaching potential participants. The above listed also will be the only consentors for the study. The recruitment process will occur during the outpatient visits being held at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. HIPAA guidelines and good clinical practice will be followed at all times to ensure that the privacy of participants included in the recruitment process are strictly guarded.

2. Patients will be registered by the Radiation Oncology clinical subjects coordinator after eligibility is confirmed and informed consent is obtained.

3. The EORTC QLQ-C30, QLQ-CR38, and QLQ-CR29 forms will be completed by patients at the following time point:

1. Within 3 weeks prior to start of radiotherapy

2. During the 4th week of radiotherapy (when treatment-related symptoms are expected to peak)

3. Approximately one month after completion of radiotherapy during a follow-up visit

4. The QOL forms (QLC-C30, QLQ-CR38, and CR29) will be self-administered surveys. A nurse or other healthcare provider will be available to help the patient with any questions regarding the QOL forms.

5. The symptom inventory will be collected in an interview by a nurse or other healthcare provider at the following time points: d. Within 3 weeks prior to start of radiotherapy e. Once weekly during radiotherapy f. Approximately one month after completion of radiotherapy during a follow-up visit.

Eligibility Criteria

Inclusion Criteria:

• All of the following questions must be answered "yes" for a patient to be eligible for this protocol.

1. Is there a working diagnosis of rectal cancer? YES NO

2. Will the patient be receiving neoadjuvant concurrent chemotherapy and pelvic radiation? YES NO

3. Is the pelvic radiation planned for a dose of 45-54 Gy and will it be delivered using a standard 3-field technique? YES NO

4. Is the patient ≥ 18 years of age? YES NO

5. Can the patient give informed consent? YES NO

Exclusion Criteria:

• All of the following questions must be answered "no" for a patient to be eligible for this protocol.

1. Has there been prior radiation to the pelvis? YES NO

2. Is the patient in the "special category" designated by the Public Health Service (patients younger than 18, pregnant women, and prisoners)? YES NO

Trial Contact Information

Trial Lead Organizations/Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Joseph Herman, M.D.

Principal Investigator

Joseph Herman, M.D.		Ph: 410-502-3823
		Email: jherman15@jhmi.edu

U.S.A.
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Joseph Herman, M.D.	Ph: 410-502-3823
			Email: jherma15@jhmi.edu
		Terrence Caldwell	Ph: 443-287-1889
			Email: caldwte@jhmi.edu

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00414232
Information obtained from ClinicalTrials.gov on May 13, 2009