Study for Wait and Watch Suitable in Rectal Cancer

Rectal Neoplasms Clinical Trial

— ARROW  

Official title:

Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch Treated With Total Neoadjuvant Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06252142
• Other study ID #: 4307
• Status: Not yet recruiting
• Start date: February 19, 2024
• Est. completion date: February 19, 2028

Study information

• Verified date: February 2024
• Source: Tata Memorial Centre
• Contact: Dr Rahul Krishnatry, MD
• Phone: 022-24177000
• Email: krishnatry[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: February 19, 2028
• Est. primary completion date: February 19, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Other:
• Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose
Short Course radiotherapy followed by eighteen weeks of chemotherapy in between sandwich brachy therapy followed by observation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Successful organ preservation rate	Percentage of patient avoiding surgery at median of follow up of 3 years.	3 years.
Primary	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).	3 years
Primary	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).	3 years
Primary	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)	3 years
Primary	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)	3 yeasrs
Primary	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).	3 years
Primary	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.	3 years
Primary	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.	3 years
Secondary	Local regrowth rates	Percentage of patients developing local regrowth, earlier deemed complete or near complete clinical response	3 years
Secondary	Total Mesorectal Excision rates	Percentage of patients requiring TME-based surgical management.	3 years
Secondary	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.	3 Years
Secondary	Disease-free survival	From the date of start of treatment till the date of diagnosis of disease progression at any site	3 Years
Secondary	Overall survival.	from the date of start treatment till date of death (any cause)	3 years.
Secondary	Colostomy-free survival.	From the date of start of treatment till the date of permanent colostomy procedure.	3 years
Secondary	Total Mesorectal Excision free survival	From the date of start of treatment till the date of TME-based surgery	3 years
Secondary	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.	3 years