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Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?


N/A
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Rectum

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Trial Information

Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?


Inclusion Criteria:



- Aged > 18

- Informed written consent

- Histological confirmation of adenocarcinoma of rectum

- Undergoing pre-operative radiotherapy/ chemotherapy

- Completion of pre-operative treatment

Exclusion Criteria:

- Aged < 18

- Absence of pre-operative RT/CT

- Medical/ psychiatric conditions that compromise the patients ability to give informed
consent

- Contra-indications to MRI, i.e. hip prothesis, cardiac pacemaker

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The proportion of patients downstaged by T stage will be expressed as a percentage with 95% confidence interval (95% CI) for each treatment arm and compared between the two arms using the Fisher's exact test.

Outcome Time Frame:

6-12 weeks

Safety Issue:

No

Principal Investigator

Diana Tait

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

CCR3227

NCT ID:

NCT01037049

Start Date:

October 2009

Completion Date:

February 2012

Related Keywords:

  • Adenocarcinoma of the Rectum
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms

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