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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Diagnostic Active 18 and over Other 07-151 NCT00574353

Trial Description

Summary

When used with a different radioactive tracer called FMISO, a PET scan can find areas of low oxygen in the tumor. We think that having areas of low oxygen is a reason why some tumors are hard to treat with radiation.

FMISO PET scans have been done in 6 patients with rectal cancer. These patients had cancer that could not be operated on and that had spread to other areas. In this group of patients, FMISO PET scans were able to find the low oxygen areas in their tumors. But this study included only a few patients. In the present study, we want to use FMISO PET scans in patients who have tumors that can be operated on. This group of patients will have radiation, chemotherapy or both before they have their surgery. We want to see if FMISO PET can find low oxygen areas in this distinct group of patients.

Further Study Information

Hypoxia is a characteristic feature of malignant solid tumors associated with poor prognosis and resistance to chemotherapy and radiation. It has also been shown (6) that the presence of hypoxia may reduce long-term survival post surgery. Hypoxia renders tumor cells up to three times more resistant to ionizing radiation than aerobic cells. The presence of hypoxic regions within tumors may be one factor leading to local failure after treatment with standard pre-operative radiotherapy doses. If these regions could be identified and verified using a non-invasive imaging technique prior to surgery, they could be specifically targeted using sophisticated planning techniques such as intensity modulated radiation therapy (IMRT) to deliver higher doses ionizing radiation with preoperative radiotherapy. Future studies using IMRT to "dose paint" areas of hypoxia within tumors will build upon the results of this feasibility study. Ultimately, by the delivery of differential dose of radiation to the tumor, in combination with surgery, the local control rates of rectal cancer patients may further be improved.

Eligibility Criteria

Inclusion Criteria:

• Able to provide written informed consent

• Histologically confirmed diagnosis of Stage 2 or Stage 3 rectal carcinoma requiring preoperative radiation, chemotherapy or both, per treating physician

• 18 years of age or older

• Karnofsky performance status ≥ 70

Exclusion Criteria:

• Patients who underwent surgical resection for the same disease (except for biopsy)

• Any prior radiotherapy to the pelvis

• Prior chemotherapy or radiotherapy within the last 3 years

• Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Jose Guillem, MD

Principal Investigator

Jose Guillem, MD		Ph: 212-639-8278
		Email: guillemj@mskcc.org

John Humm, PhD		Ph: 212-639-7367
		Email: hummj@mskcc.org

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Jose Guillem, MD	Ph: 212-639-8278
			Email: guillemj@mskcc.org
		Jose Guillem, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00574353
Information obtained from ClinicalTrials.gov on October 03, 2008