To hear about similar clinical trials, please enter your email below
Trial Title:
Study for Wait and Watch Suitable in Rectal Cancer
NCT ID:
NCT06252142
Condition:
Rectal Neoplasms
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Rectal Cancer
Wait and Watch
SCRT
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose
Description:
Short Course radiotherapy followed by eighteen weeks of chemotherapy in between sandwich
brachy therapy followed by observation.
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
Locally Advanced Rectal Cancer Patients.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
- Lower - mid rectum starting upto 7 cm from Anal verge
- Previously treated with the intent of wait-and-watch with TNT with or without
brachytherapy and completed TNT part of treatment (for retrospective cohort)
- Patients not consenting to ongoing interventional studies, such as the SCOTCH study
or any future studies, will be considered and offered
- Consent to be on standard regular follow-up and answer quality of life
questionnaires
Exclusion Criteria:
- Not eligible as per the above inclusion criteria
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tata Memorial centre
Address:
City:
Mumbai
Country:
India
Status:
Recruiting
Contact:
Last name:
RAHUL KRISHNATRY, MD
Email:
krishnatry@gmail.com
Start date:
April 1, 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Tata Memorial Centre
Agency class:
Other
Source:
Tata Memorial Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06252142
