Node-Sparing Chemo-Radiation for Anal Cancer
(INSPIRE Trial)
Recruiting in Palo Alto (17 mi)
Overseen byKurian Joseph, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AHS Cancer Control Alberta
Disqualifiers: Prior pelvic radiation, Pregnancy, Metastases, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing if skipping certain radiation treatments is as effective as giving them for early-stage anal cancer patients without lymph node involvement. The goal is to reduce side effects and improve quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Node-Sparing Chemo-Radiation for Anal Cancer?
Chemoradiotherapy (CRT) is considered the standard treatment for anal cancer, allowing patients to maintain anal function. Studies have shown that CRT is effective for locally advanced anal carcinoma, and it is also used successfully in HIV-positive patients with anal cancer.
12345Is chemoradiotherapy (CRT) generally safe for humans?
Chemoradiotherapy (CRT) for anal cancer is associated with substantial toxicity, including acute organ toxicity, which can sometimes lead to discontinuation of treatment due to adverse effects. However, it is a standard treatment and has been used in various studies, indicating it is generally considered safe enough for clinical use, though side effects are common.
13678How is node-sparing chemo-radiation treatment for anal cancer different from other treatments?
Node-sparing chemo-radiation treatment for anal cancer is unique because it involves a reduced radiation dose to uninvolved lymph nodes, which may help minimize side effects while still effectively treating the cancer. This approach contrasts with standard treatments that typically apply higher radiation doses to both the tumor and surrounding lymph nodes.
12359Eligibility Criteria
This trial is for adults over 18 with early-stage anal cancer (T1-3 N0 M0) who haven't had pelvic radiation, chemotherapy, or surgery for it except biopsy. They must be able to consent and have a good performance status. Women can't be pregnant/breastfeeding and must test negative for pregnancy; men agree not to donate sperm. All participants should commit to effective birth control and have no other health issues that could affect the study.Inclusion Criteria
I am a woman who can have children and have a negative pregnancy test.
My cancer is confirmed to be squamous cell carcinoma.
My scans show no cancer in the groin lymph nodes.
+10 more
Exclusion Criteria
Pregnancy or lactation
I am a T1N0 patient planning to have my first surgery.
I have had radiation therapy to my pelvic area before.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Radiotherapy with concurrent 5-fluorouracil and mitomycin-C combination treatment. Radiotherapy consists of 5400 cGy delivered in 30 fractions over 6 weeks.
6 weeks
Weekly visits for radiotherapy sessions
Follow-up
Participants are monitored for disease-free survival and quality of life. Follow-up includes PET/CT imaging and quality of life assessments.
36 months
Every 3 months for 2 years, then every 6 months for another year
Participant Groups
The study tests if avoiding groin radiation in patients with normal sentinel node biopsies and PET-CT scans is as effective as preventative groin radiation in treating anal canal cancer. It also examines whether this approach reduces side effects and improves quality of life.
1Treatment groups
Experimental Treatment
Group I: chemo-radiation treatmentExperimental Treatment1 Intervention
Radiotherapy with concurrent 5-fluorouracil and mitomycin-C combination treatment.
Radiotherapy consists of 5400 cGy delivered in 30 fractions over 6 weeks. The investigators will be using the current standard regimen for the study or no change in the current CCI treatment regimen. However, the radiotherapy target will be smaller than current practice since the investigators will be omitting prophylactic inguinal irradiation.
Chemo-Radiation Treatment is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Chemoradiation for:
- Anal cancer
- Rectal cancer
- Colorectal cancer
🇺🇸 Approved in United States as Chemoradiation for:
- Anal cancer
- Rectal cancer
- Colorectal cancer
🇨🇦 Approved in Canada as Chemoradiation for:
- Anal cancer
- Rectal cancer
- Colorectal cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cross Cancer InstituteEdmonton, Canada
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Who Is Running the Clinical Trial?
AHS Cancer Control AlbertaLead Sponsor
References
Results of Surgical Salvage Treatment for Anal Canal Cancer: A Retrospective Analysis with Overview of the Literature. [2018]Chemoradiotherapy (CRT) is the gold standard treatment for anal cancer, which permits the maintenance of the anal function. However, about 30-40% of patients develop local disease progression, for which surgery represents a good salvage therapy. The aim of this study is to evaluate survival and morbidity rate in patients who undergo salvage surgery in our single institution, with an overview of the literature.
Volumetric intensity-modulated arc therapy vs. 3-dimensional conformal radiotherapy for primary chemoradiotherapy of anal carcinoma: Effects on treatment-related side effects and survival. [2018]Primary chemoradiotherapy (CRT) is the standard treatment for locally advanced anal carcinoma. This study compared volumetric intensity-modulated arc therapy (VMAT) to 3-dimensional conformal radiotherapy (3DCRT) in terms of treatment-related side effects and survival.
Concurrent chemoradiotherapy with 5-fluorouracil and mitomycin C for invasive anal carcinoma in human immunodeficiency virus-positive patients receiving highly active antiretroviral therapy. [2022]To report the clinical outcomes of chemoradiotherapy (CRT) for anal carcinoma in human immunodeficiency virus (HIV)-infected patients receiving highly active antiretroviral therapy.
HIV-specific differences in outcome of squamous cell carcinoma of the anal canal: a multicentric cohort study of HIV-positive patients receiving highly active antiretroviral therapy. [2022]To define clinical outcome after definitive chemoradiotherapy (CRT) of anal carcinoma in HIV-infected patients treated with highly active antiretroviral therapy (HAART).
Postoperative versus definitive chemoradiation in early-stage anal cancer. Results of a matched-pair analysis. [2021]The goal of the present study was to comparatively assess the results of definitive chemoradiation (CRT) with or without previous macroscopically complete resection in patients with early-stage node-negative (T1-2 N0) anal carcinoma.
Prospective evaluation of acute toxicity and patient reported outcomes in anal cancer and plan optimization. [2019]Chemoradiotherapy (CRT) is the standard therapy for localized anal cancer (AC), but this treatment is associated with substantial toxicity. However, there is a lack of prospectively collected toxicity and patient reported outcome (PRO) data from larger cohorts. The purpose was to prospectively collect and determine agreement between physician assessed toxicity (CTCAE) and PRO during and after CRT and to compare IMRT, VMAT and proton-based planning in a subgroup of patients.
Acute organ toxicity correlates with better clinical outcome after chemoradiotherapy in patients with anal carcinoma. [2021]Previous studies have shown that acute organ toxicity to (chemo)radiotherapy (CRT) is associated with improved oncological outcome in various tumor types. The aim of the present study was to investigate the relationship of toxicity with clinical outcome in a large cohort of 223 patients with anal squamous cell carcinoma (ASCC) treated with standard CRT.
[Three cases of anal squamous cell carcinoma treated with chemoradiotherapy]. [2015]We reviewed the clinical records of 3 patients with anal squamous cell carcinoma treated with chemoradiotherapy (CRT). Case 1: The patient was diagnosed with StageI (T1N0M0) and treated with cisplatin (CDDP)+5-FU+radiation. Chemotherapy was discontinued after the second course because of adverse effects. She achieved partial response(PR), and underwent a salvage surgery. Seven months after the surgery, she died from other comorbidities. Case 2: The patient was diagnosed with Stage I (T1N0M0) and treated with CDDP+5-FU+radiation. Chemotherapy was discontinued after the second course because of adverse effects. He achieved PR, and underwent a salvage surgery. Three years and 7 months after the surgery, he died from other comorbidities. Case 3: The patient was diagnosed with Stage IIIB (T4N1M0) and treated with MMC+S-1+radiation. Chemotherapy was discontinued after the first course because of adverse effects. She achieved complete response (CR) and is still surviving without cancer recurrence. We conclude that CRT is an effective treatment for anal squamous cell carcinoma.
Reduced radiation dose for elective nodal irradiation in node-negative anal cancer: back to the roots? [2018]Chemoradiation (CRT) is the standard of care in patients with node-positive (cN+) and node-negative (cN0) anal cancer. Depending on the tumor size (T-stage), total doses of 50-60 Gray (Gy) in daily fractions of 1.8-2.0 Gy are usually applied to the tumor site. Inguinal and iliac lymph nodes usually receive a dose of ≥ 45 Gy. Since 2010, our policy has been to apply a reduced total dose of 39.6 Gy to uninvolved nodal regions. This paper provides preliminary results of the efficacy and safety of this protocol.