Radiotherapy for Rectal Cancer

(ROBIN Trial)

Recruiting at 5 trial locations

Overseen By Fabiana Gregucci, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must not be taking: Immunosuppressants, Anticancer, Experimental drugs

Disqualifiers: Recurrent cancer, Unresectable cancer, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if a specific treatment can help the body's defenses fight a type of cancer more effectively. It focuses on patients who usually receive this treatment as part of their care. The study aims to see if the treatment not only targets cancer cells but also helps the body's defenses attack them.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic immunosuppressive medication or other anticancer or experimental therapies. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Short Course Radiation Therapy (scRT) for rectal cancer?

Research shows that preoperative short-course radiation therapy (SCRT) is an important option for treating rectal cancer, with studies indicating it can help reduce the chance of cancer returning after surgery. However, the best timing for surgery after SCRT and its comparison to other treatments like long-course radiochemotherapy is still debated. ^{1 2 3 4 5}

Is short-course radiation therapy (SCRT) safe for humans?

Research shows that preoperative short-course radiation therapy (SCRT) for rectal cancer is generally safe, with studies indicating good disease control and manageable toxicity levels. ^{1 2 3 5 6}

How is short-course radiation therapy (scRT) different from other treatments for rectal cancer?

Short-course radiation therapy (scRT) for rectal cancer is unique because it involves a shorter, more intense period of radiation before surgery, which may influence the timing and outcomes of surgery. Unlike long-course radiochemotherapy, scRT is often used in combination with chemotherapy and can be part of a nonoperative management strategy, offering a different approach to treatment. ^{1 2 3 4 5}

Research Team

Silvia Formenti, M.D.

Principal Investigator

Weill Medical College of Cornell University

Encouse Golden, M.D., Ph.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

Adults over 18 with a specific type of rectal cancer that hasn't spread far or been treated yet. They must be in good health, not pregnant, and willing to use birth control. People can't join if they've had certain treatments before, have more advanced cancer, are on strong immune system drugs, or have other serious health issues.

Inclusion Criteria

My diagnosis is rectal adenocarcinoma.

I am not on antibiotics for an infection.

I am fully active or can carry out light work.

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment would make them inappropriate candidates for entry into this study

My rectal cancer has come back.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive short course radiation therapy (scRT) of 25Gy over 5 days for localized rectal cancer

1 week

5 visits (in-person)

Surgery

Surgical procedure to assess pathological response and collect biospecimens

Week 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Short Course Radiation Therapy (scRT)
• Total Mesenteric Excision (TME)

Trial Overview The trial is testing how standard short course radiation therapy affects the immune response in rectal cancer patients who will also undergo surgery called Total Mesenteric Excision. It's for those whose cancer hasn't spread too much and aims to understand treatment effects better.

Participant Groups

Group I: Single cohort Experimental Treatment 2 Interventions

Eligible patients will receive short course radiation therapy (scRT) of 25Gy over 5 days (fractions) for their localized rectal cancer. Research bloods stool and tissue will be collected at three time points: Baseline, end of radiation therapy and at surgery.

Short Course Radiation Therapy (scRT) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Short Course Radiation Therapy for:

• Rectal cancer
• Locally advanced rectal cancer

Approved in United States as Short Course Radiation Therapy for:

• Rectal cancer
• Locally advanced rectal cancer

Approved in Canada as Short Course Radiation Therapy for:

• Rectal cancer
• Locally advanced rectal cancer

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 3469 rectal cancer patients who underwent preoperative short-course radiotherapy (SCRT), the majority (76%) had surgery within 7 days of treatment, but the timing did not affect postoperative outcomes such as mortality or length of hospital stay.

The findings indicate that the interval between SCRT and surgery does not significantly influence 30-day postoperative mortality or 1-year survival, providing important real-world evidence that can help guide treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time to Surgery Following Short-Course Radiotherapy in Rectal Cancer and its Impact on Postoperative Outcomes. A Population-Based Study Across the English National Health Service, 2009-2014. Levick, BA., Gilbert, AJ., Spencer, KL., et al.[2021]

In a study of 57 patients with locally advanced rectal cancer, neoadjuvant short-course radiation therapy (SCRT) showed similar effectiveness in tumor response and safety outcomes whether surgery was performed immediately or after a delay, indicating SCRT is well-tolerated regardless of timing.

Patients who had surgery delayed after SCRT experienced significantly higher rates of nodal downstaging (64.7% vs. 18.2%), suggesting that delaying surgery may enhance certain aspects of tumor response without increasing toxicity or complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathologic Response and Postoperative Complications After Short-course Radiation Therapy and Chemotherapy for Patients With Rectal Adenocarcinoma. Avila, S., Chang, GJ., Dasari, NA., et al.[2021]

In a clinical trial involving 19 patients with nonmetastatic rectal adenocarcinoma, short-course radiation therapy (SCRT) followed by chemotherapy achieved a high clinical complete response (cCR) rate of 68% at one year, indicating its efficacy as a nonoperative treatment option.

Patients who achieved cCR had significantly better 2-year disease-free survival (93% vs 67%) and overall survival (100% vs 67%) compared to those who did not, while maintaining intact anorectal function and experiencing no severe late effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonoperative Rectal Cancer Management With Short-Course Radiation Followed by Chemotherapy: A Nonrandomized Control Trial. Kim, H., Pedersen, K., Olsen, JR., et al.[2022]

In a study of 1606 rectal cancer patients, the overall local recurrence rate after potentially curative surgery was only 4.0%, suggesting that the risk of recurrence is low.

The findings indicate that routine preoperative short-course radiotherapy may not be necessary for all patients, as selective use could be more beneficial, especially when local recurrence rates are already low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low rates of local recurrence after surgical resection of rectal cancer suggest a selective policy for preoperative radiotherapy. Senapati, A., O'Leary, DP., Flashman, KG., et al.[2012]

A meta-analysis of 11 studies involving 1984 patients found that preoperative short-course radiotherapy (SCRT) is as effective as long-course radiochemotherapy (LCRT) for long-term survival in locally advanced rectal cancer, with no significant differences in overall survival, disease-free survival, or local recurrence rates.

SCRT may be a preferable option in situations with long waiting lists or limited medical resources, as it provides similar efficacy to LCRT while potentially reducing treatment time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative short-course radiotherapy and long-course radiochemotherapy for locally advanced rectal cancer: Meta-analysis with trial sequential analysis of long-term survival data. Wang, X., Zheng, B., Lu, X., et al.[2019]

Preoperative short-course radiation therapy (SCRT) followed by immediate surgery has shown high efficacy in treating rectal cancer, with 5-year locoregional control at 95.9%, disease-free survival at 76.4%, and overall survival at 84.6% based on a study of 202 patients with clinical stage I-III disease.

The treatment was found to be safe, with a late severe toxicity rate of only 11.4%, suggesting that SCRT could be a viable option for rectal cancer patients in the U.S., especially as national guidelines begin to support its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative short-course radiation therapy for rectal cancer provides excellent disease control and toxicity: Results from a single US institution. Roy, A., Mahasittiwat, P., Weiner, AA., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Time to Surgery Following Short-Course Radiotherapy in Rectal Cancer and its Impact on Postoperative Outcomes. A Population-Based Study Across the English National Health Service, 2009-2014. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Pathologic Response and Postoperative Complications After Short-course Radiation Therapy and Chemotherapy for Patients With Rectal Adenocarcinoma. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Nonoperative Rectal Cancer Management With Short-Course Radiation Followed by Chemotherapy: A Nonrandomized Control Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Low rates of local recurrence after surgical resection of rectal cancer suggest a selective policy for preoperative radiotherapy. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Preoperative short-course radiotherapy and long-course radiochemotherapy for locally advanced rectal cancer: Meta-analysis with trial sequential analysis of long-term survival data. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Preoperative short-course radiation therapy for rectal cancer provides excellent disease control and toxicity: Results from a single US institution. [2022]