Study for Wait and Watch Suitable in Rectal Cancer
ConditionRectal Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorTata Memorial Centre
About this trial
One of the standard treatment options offered to patients of locally advanced rectal cancer is neoadjuvant (treatment given before surgery) radiotherapy \& chemotherapy followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the wait and watch strategy is also an option. This is another standard treatment option for patients of locally advanced rectal cancers. In this, the patient is monitored after treatment completion. In this study, investigators are only going to observe the patient's response to treatment, monitor their side-effects due to treatment and assess their quality of life using standardized quality of life questionnaires. No additional tests or hospital visits will be required as a part of this study. The patient will be followed up, as per standard follow-up protocol, for at least 2 years after the completion of their treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age more than 18 years.
Patients diagnosed with locally advanced rectal cancer and suitable for wait and watch as per international consensus guidelines [3,1]
Biopsy-proven adenocarcinoma (non-signet or non-mucinous) T1-4a or N0-2, plus Limited metastatic disease (metastases in 1to 2 organs OR 1to 2 metastases involving a single organ)
Non-circumferential disease with CCL less than 7 cm
Disqualifiers
Not eligible as per the above inclusion criteria
Trial population
Locally Advanced Rectal Cancer Patients.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
260 Participants
are grouped into 4 trial groupsGroup A: Retrospective LCRT
Group B: Retrospective SCRT
Group C: Prospective LCRT
Group D: Prospective SCRT
Trial outcomes
Primary outcomes
1
1. Successful organ preservation rate
Percentage of patient avoiding surgery at median of follow up of 3 years.
Time frame
3 years.2
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CR29 (Colorectal)
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of CR29 (Colorectal).
Time frame
3 years3
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire C30 (Cancer)
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of C30 (Cancer).
Time frame
3 years4
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire SH22 (Sexual Health)
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of SH22 (Sexual Health)
Time frame
3 yearsSecondary outcomes
1
Local regrowth rates
Percentage of patients developing local regrowth, earlier deemed complete or near complete clinical response
Time frame
3 years2
Total Mesorectal Excision rates
Percentage of patients requiring TME-based surgical management.
Time frame
3 years3
Loco-regional control
Responce is assessed by comparing the presence or absence of disease between the baseline and response evaluation scan/scopy. Response evaluation will be done by clinical, radiological and endoscopic assessment and disease will be restaged with TNM.
Time frame
3 Years4
Disease-free survival
From the date of start of treatment till the date of diagnosis of disease progression at any site
Time frame
3 YearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov