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.
The standard treatment options offered to patients of locally advanced rectal cancer are neoadjuvant (treatment given before surgery), radiotherapy \& chemotherapy, followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the watch and wait or non-operative management is an option. In this, the patient is monitored after treatment completion. In this study, investigators will only 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. The patient will be followed up, as per standard follow-up protocol, for at least two years after the completion of their treatment.
Study Type
OBSERVATIONAL
Enrollment
260
Tata Memorial centre
Mumbai, Maharashtra, India
RECRUITING1. Successful organ preservation rate
Percentage of patient avoiding surgery at median of follow up of 3 years.
Time frame: 3 years.
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 years
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 years
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 years
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire PRT 20 (Proctitis).
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of PRT 20 (Proctitis)
Time frame: 3 yeasrs
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CIPN 20 (Chemotherapy induced peripheral neuropathy).
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of CIPN 20 (Chemotherapy induced peripheral neuropathy).
Time frame: 3 years
Low Anterior Resection Syndrome Score (LARS)
The LARS score is a validated and frequently used tool measuring bowel dysfunction after sphincter sparing surgery for rectal cancer. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time frame: 3 years
International Prostate Symptom Score (IPSS)
This health tool aims to collect and analyse the perceived symptoms of patients suffering from urinary tract dysfunctions and benign prostatic hyperplasia (BPH)..The overall score in the I-PSS ranges between 0 and 35, from asymptomatic to very symptomatic status.
Time frame: 3 years
Local regrowth rates
Percentage of patients developing local regrowth, earlier deemed complete or near complete clinical response
Time frame: 3 years
Total Mesorectal Excision rates
Percentage of patients requiring TME-based surgical management.
Time frame: 3 years
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 Years
Disease-free survival
From the date of start of treatment till the date of diagnosis of disease progression at any site
Time frame: 3 Years
Overall survival.
from the date of start treatment till date of death (any cause)
Time frame: 3 years.
Colostomy-free survival.
From the date of start of treatment till the date of permanent colostomy procedure.
Time frame: 3 years
Total Mesorectal Excision free survival
From the date of start of treatment till the date of TME-based surgery
Time frame: 3 years
Treatment-related toxicities
Acute and late treatment-related Gastro Intestinal, Genito Urinary or any other Common Terminology Criteria for Adverse Events toxicities of grade 3 or higher. Grade refers to the severity of the Adverse Events. And it graded as grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life-threatening consequences and grade 5 is death.
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Time frame: 3 years