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Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037049
First Posted: December 21, 2009
Last Update Posted: June 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
December 18, 2009
December 21, 2009
June 23, 2015
October 2009
June 2015   (Final data collection date for primary outcome measure)
The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI]. [ Time Frame: 6-12 weeks ]
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. [ Time Frame: 6-12 weeks ]
Complete list of historical versions of study NCT01037049 on ClinicalTrials.gov Archive Site
  • Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI]. [ Time Frame: 3 months ]
  • Difference in proportion of patients in each arm undergoing sphincter saving surgery. [ Time Frame: 3 months ]
  • Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity. [ Time Frame: 3 months ]
  • An analysis will also be undertaken using multivariate and linear regression analysis to evaluate the association of ypT and ypN stage as a potential independent predictors of SUV (max) baseline and after radiotherapy (pre-surgery) in the two arms. [ Time Frame: 3 months ]
  • Local and distant recurrence rates. [ Time Frame: 5 years ]
  • Radiotherapy related toxicity rates. [ Time Frame: 5 years ]
  • Patients showing reduction in a) T stage, b) N stage and c) Tumour regression. [ Time Frame: 3 months ]
  • Patients having sphincter sparing surgery compared by Fisher's exact test. [ Time Frame: 3 months ]
  • Morbidity, 30 day mortality and CRM positivity will be compared using Fisher's exact test or the Chi squared test. [ Time Frame: 3 months ]
  • An analysis will also be undertaken using multivariate and linear regression analysis to evaluate the association of ypT and ypN stage as a potential independent predictors of SUV (max) baseline and after radiotherapy (pre-surgery) in the two arms. [ Time Frame: 3 months ]
Not Provided
Not Provided
 
Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks
Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?

The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks.

Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
  • Adenocarcinoma of the Rectum
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Neoplasms, Glandular and Epithelial
  • Neoplasms by Histologic Type
  • Neoplasms
  • Neoplasms, Cystic, Mucinous, and Serous
  • Colorectal Neoplasms
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Intestinal Diseases
  • Rectal Diseases
Other: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
  • No Intervention: Group 1
    Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy
  • Experimental: Group 2
    Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
    Intervention: Other: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
237
July 2019
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   Cyprus,   United Kingdom
 
 
NCT01037049
CCR3227
Yes
Not Provided
Not Provided
Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Not Provided
Principal Investigator: Diana Tait Royal Marsden NHS Foundation Trust
Principal Investigator: Gina Brown Royal Marsden Hospitals NHS Foundation Trust
Royal Marsden NHS Foundation Trust
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP