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Rectal NeoplasmsARROWNCT06252142

Study for Wait and Watch Suitable in Rectal Cancer

An observational study of Rectal Neoplasms, run by Tata Memorial Centre at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Rectal Neoplasms
How many people
260 participants
Where
1 siteIndia
Study dates
1 Apr 2024to Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Locally Advanced Rectal Cancer Patients.

Who may be able to join

  • 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 or LCRT with or without brachytherapy and completed TNT part of treatment till March 2024(for retrospective cohort).
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  • 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
  • Patients on lost to follow up will be included if they have completed treatment and taking follow up locally, accepting telephonically to participate.

Who cannot join

  • Not eligible as per the above inclusion criteria

Trial locations and contacts

1 site in 1 country.

Rahul Krishnatry, MD contact

022-24177000 ext. . 7028

krishnatry@gmail.com

India1 site, 1 recruiting

  • Tata Memorial centre

    Mumbai, Maharashtra

    RAHUL KRISHNATRY, MD, krishnatry@gmail.com

    Recruiting

Other trials in India

About this study

Official title: Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch (ARROW)

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.

Read the 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.

Keywords
Rectal Cancer, Wait and Watch, SCRT, LCRT
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06252142
Study groupRoleWhat they receive
Retrospective LCRTNot described
Retrospective SCRTNot described
Prospective LCRTNot described
Prospective SCRTNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Successful organ preservation rate

    Percentage of patient avoiding surgery at median of follow up of 3 years.

    Measured: 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).

    Measured: 3 years

  3. 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).

    Measured: 3 years

  4. 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)

    Measured: 3 years

  5. 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)

    Measured: 3 yeasrs

  6. 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).

    Measured: 3 years

  7. 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.

    Measured: 3 years

  8. 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.

    Measured: 3 years

Secondary outcomes (8)

  1. Local regrowth rates

    Percentage of patients developing local regrowth, earlier deemed complete or near complete clinical response

    Measured: 3 years

  2. Total Mesorectal Excision rates

    Percentage of patients requiring TME-based surgical management.

    Measured: 3 years

  3. 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.

    Measured: 3 Years

  4. Disease-free survival

    From the date of start of treatment till the date of diagnosis of disease progression at any site

    Measured: 3 Years

  5. Overall survival.

    from the date of start treatment till date of death (any cause)

    Measured: 3 years.

  6. Colostomy-free survival.

    From the date of start of treatment till the date of permanent colostomy procedure.

    Measured: 3 years

  7. Total Mesorectal Excision free survival

    From the date of start of treatment till the date of TME-based surgery

    Measured: 3 years

  8. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2024
  2. Study start1 Apr 2024
  3. Primary completionFeb 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06252142
Sponsor's protocol ID
4307
Acronym
ARROW
Status last verified
Sep 2024
First submitted
1 Feb 2024
Last updated
10 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Neoplasms, run by Tata Memorial Centre at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rahul Krishnatry, MD (022-24177000 ext. . 7028, krishnatry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Successful organ preservation rate (time frame: 3 years.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06252142.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.

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