Know Cancer

or
forgot password

The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Locally Advanced Rectum Cancer

Thank you

Trial Information

The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer


Inclusion Criteria:



- Histopatologically verified adenocarcinoma in the rectum

- T4 tumor eller T3 tumor < 10 cm from the anus and < 5 mm from the mesorectal fascie
measured by MR scan. At the distal part of the rectum the distance to the mesorectal
fascie is < 5 mm and therefore all T3 tumors are included in this area

- Suitable for preoperative radiation and chemotherapy

- No distant metastases

- Age >18 years

- Hematology ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.

- Biochemistry Bilirubin ≤ 3 x UNL. ALAT ≤ 5 x UNL

- Creatinine ≤ UNL

- Contraception for fertile women

- Written and orally informed consent

Exclusion Criteria:

- Other malignant disease within 5 years, excl. non-melanotic skin cancer

- Previous radiation treatment of the pelvis

- Pregnant or breastfeeding women

- Surgery within 6 weeks prior to enrollment

- Serious concurrent medical disease

- Enrollment in study "A prospective observational study of patients with rectum cancer
after concomitant radiation and chemotherapy", where the patients are potientially
not operated.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Response to chemoradiotherapy measured by TRG

Outcome Time Frame:

8 weeks after chemoradiation treatment

Safety Issue:

No

Authority:

Denmark: Ethics Committee

Study ID:

S-20100054

NCT ID:

NCT01257035

Start Date:

November 2010

Completion Date:

August 2012

Related Keywords:

  • Locally Advanced Rectum Cancer
  • Rectum cancer
  • FAZA
  • 18F-FAZA-PET/CT
  • Radiotherapy
  • Chemoradiotherapy
  • Rectal Neoplasms

Name

Location